cancer trials in ireland 2021 - hrb · hrb cancer trials in ireland 2021 5 2 aims and objectives...

Key Dates & Times:

Call opens 04 August 2020 Virtual Q&A October 2020 Application Closing Date 13:00, 15 January 2021

Cancer trials in Ireland 2021

Guidance Notes

Applications must be completed and submitted through the HRB online Grant E-Management System (GEMS) (https://grants.hrb.ie), and this system will close automatically at the stated deadline and

timeline listed above. Applicants are strongly advised to read the ‘Detailed guidance notes for applicants’ appended to this document prior to completing the application forms.

https://grants.hrb.ie/

HRB Cancer trials in Ireland 2021

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Cancer trials in Ireland 2021

Guidance Notes

Table of Contents 1 Introduction ........................................................................................................................................................... 3

2 Aims and Objectives .............................................................................................................................................. 5

3 Scope ..................................................................................................................................................................... 5

4 HRB Oversight and monitoring .............................................................................................................................. 9

5 Funding and Duration of Awards ......................................................................................................................... 10

6 Eligibility............................................................................................................................................................... 12

7 Governance.......................................................................................................................................................... 16

8 Trial Registration and Reporting .......................................................................................................................... 16

9 FAIR Data Management and Stewardship ........................................................................................................... 17

10 Public and Patient Involvement (PPI) in research .......................................................................................... 17

11 General Data Protection Regulation ............................................................................................................... 18

12 Application, Review Process and Assessment Criteria ................................................................................... 19

13 Conflict of Interest .......................................................................................................................................... 21

14 Timeframe ...................................................................................................................................................... 22

15 Contact ........................................................................................................................................................... 22

Appendix I: Detailed Guidance on the Application Form for Clusters ................................................... 23

Appendix II: Detailed Guidance on the National Cancer Clinical Trials Network Application Form ........... 47

Appendix III: FAIR Data Management ......................................................................................................... 68

Appendix IV: References/Useful Links ........................................................................................................ 71


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1 Introduction

The Health Research Board (HRB) Strategy 2016 – 2020: Research. Evidence. Action.1 sets out the aim to

support the design, conduct and evaluation of healthcare intervention studies in order to improve

health outcomes and health service delivery. Our current strategy commits the organisation to

consolidate and build on progress made in constructing a coherent and integrated clinical trials

infrastructure nationally (including facilities, equipment, coordination, research support, and networks)

to deliver such interventions. The upcoming strategy 2021 – 2030 sets out the vision to build a strong

and supportive environment for health research in Ireland building on the achievements made.

The Strategy recognises that healthcare interventions, including trials, are an essential step in translating

research discoveries into improvements in health and health services. Patients benefit from having

access to high quality clinical trials and overall outcomes are better in health systems that support

clinical trials2,3. The economy also benefits from clinical trials by supporting enterprise development in

areas such as pharma, medical devices and diagnostics; this in turn creates jobs and delivers significant

benefits to the exchequer through direct and indirect savings.

Since 2010, HRB has been driving the growth of clinical trials in Ireland and putting in place the

supporting infrastructure. In that period the HRB has invested over €100m in clinical trials

infrastructures with the overall aim of facilitating clinical trials and clinical research in Ireland that can

benefit patients, the health system and the economy.

Investment to date has been made in three Clinical Research Facilities in Ireland, to provide the

infrastructure (facilities, expert advice, research nursing support etc.) to conduct trials in any area of

health. Individual Clinical Trial Networks (CTNs) have been funded to support communities of

researchers in specific disease or health areas to develop and deliver a portfolio of trials. HRB-Clinical

Research Coordination Ireland was established as a national resource to develop Ireland as location for

clinical trials by making it easier, more efficient and faster to set up and conduct multi-centre studies.

Finally, HRB-TMRN has been funded as a national network to improve the quality of trials by driving

trials methodology research on the island of Ireland, advising researchers, and engaging in education

and capacity-building in trial methodology.

The HRB has provided funding to Cancer Trials Ireland, previously All-Ireland Cooperative Oncology

Research Group (ICORG), since 2002. Over that period the HRB has invested over €60 million to build

and enhance the capacity of hospitals with significant cancer services to conduct high-quality clinical

trials of cancer therapies in an all-island context.

1 http://www.hrb.ie/publications/hrb-publication/publications//702/ 2 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118253 3 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/414107

http://www.hrb.ie/publications/hrb-publication/publications/702/

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118253

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/414107


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Cancer Trials Ireland was established before any other clinical research infrastructures were in place and

broadly reflects the organisation of cancer services in Ireland, with a strong overlap with the footprint of

the cancer centres of excellence and their smaller satellite centres. Cancer trials are delivered in

oncology units within cancer-treating hospitals rather than through Clinical Research Facilities (CRFs)

and the absence of any national structures to support clinical trials in Ireland prior to 2007 has meant

that some of the functions now found in CRFs or HRB-Clinical Research Coordination Ireland (HRB-CRCI)

are carried out independently by cancer trials units or by the Group Central Office of Cancer Trials

Ireland.

The National Cancer Strategy (2017-2026)4, published by the Department of Health in July 2017, set a

target of doubling the number of patients on clinical trials by 2020, from 3% to 6%. Metrics gathered by

Cancer Trials Ireland show that this target is not being achieved and that the number of cancer patients

on trials has been in decline in recent years; it was at a level of about 2% in 2018.

In 2018, a scientific renewal review of Cancer Trials Ireland, by an International Panel of experts advised

that the current funding model, which is based on a credit system for hospital sites, is not optimal and

that funding is spread too thinly. As such, the panel recommended that the funding model be

restructured.

In 2020, HRB is launching a number of calls for new investment in clinical trials infrastructure. In this

next phase of investment, HRB will build on national investments and adopt a co-investment model with

the Health Service Executive (HSE), universities and other stakeholders to develop a world-class clinical

trials infrastructure with the capacity to deliver high-quality clinical trials.

As a key piece of the national clinical trials infrastructure investment, HRB is now launching a new

national call for cancer trials in Ireland which will support the establishment of cancer trial delivery

Clusters and a National Cancer Clinical Trials Network with the aim of enabling the development and

delivery of a high-quality portfolio of cancer clinical trials with relevance to health and care needs in

Ireland.

The HRB are now inviting applications to support cancer trials in Ireland as outlined below.

4 National Cancer Strategy http://health.gov.ie/wp-content/uploads/2017/07/National-Cancer-Strategy-2017-2026.pdf

http://health.gov.ie/wp-content/uploads/2017/07/National-Cancer-Strategy-2017-2026.pdf

http://health.gov.ie/wp-content/uploads/2017/07/National-Cancer-Strategy-2017-2026.pdf


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2 Aims and Objectives

The overall goal of the new funding model for HRBs investment in cancer trials in Ireland is to support

an appropriate infrastructure; enabling Irish patients to access a diverse portfolio of high-quality, safe

and compliant cancer clinical trials in Ireland.

In order to achieve this goal, essential features of the funding call include:

• a more efficient, coordinated and focused infrastructure that enables greater access to specific

expertise for the design and development, efficient and timely activation, conduct, completion

and reporting of cancer clinical trials, meeting all regulatory requirements,

• strengthened scientific excellence in cancer clinical trials by continuing to network and integrate at a national level, the critical mass of expertise and resources needed to provide Irish leadership in investigator-led and commercial cancer clinical trials,

• a more strategic approach to the portfolio of cancer clinical trials in Ireland developed or adopted within the “Clusters”,

• Strengthening of existing partnerships between the hospital sites, clinical research facilities/centres and academic partners of each cluster, to enhance governance, advance cancer clinical trials and provide appropriate incentives for clinicians to engage in cancer clinical trials,

• a more integrated and embedded system of cancer clinical research activity within the HSE/NCCP, as measured through leveraged support from the HSE/NCCP. Co-investment will be required in the form of support for core staff and/or in-kind contributions towards the operation of the clusters, which will need to be verifiable under accounting standards,

• greater transparency in all financial and governance matters related to trial activity; ensuring that the appropriate financial and underpinning governance measures are in place,

• increased number of high-quality cancer clinical trials (investigator and industry-led) in Ireland that lead to improvements in patient outcomes and/or clinical care, as measured through a formal assurance framework with clear metrics, and

• embedding patient and public involvement in all cancer clinical trials.

The investment will potentially support between 5-7 cancer delivery Clusters (one in Paediatrics) aligned with the Hospital Groups and a national Cancer Clinical Trials Network.

3 Scope

Investments are intended to build on positive achievements of our previous investment in cancer clinical

trials and other clinical trials infrastructures. Activities must complement and coordinate with other

national clinical trials infrastructure investments.

This award will provide HRB funding of up to a maximum of €21 million (inclusive of overheads) over a

five year period for the establishment of cancer trial delivery Clusters and a national Cancer Clinical

Trials Network to support cancer clinical trials in Ireland.


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3.1 Cancer trial delivery “Clusters”

The existing 11 HRB-funded cancer trial units at various hospital sites are invited by the HRB to

assemble as a “Cluster”, in partnership with each other or alone, aligned to the hospital group

delineation.

Our Lady’s Children’s Hospital Crumlin (OLCHC), soon to become Children’s Health Ireland, are issued a

specific invitation to apply as a Cluster for Paediatrics. A portion of funds is ringfenced for this purpose,

including resources to cover the governance activities currently carried out at OLHC.

Radiation oncology was highlighted, in the feedback from the oncology research community, as a

specific clinical speciality that necessitates acting as a stand-alone Cluster, separate to the medical

oncology Clusters. In this case, the HRB expect a single application for a Radiation Oncology Cluster and

that the case for a separate Cluster with national reach for cancer patients is articulated in the

application.

All applications for a Cluster must be submitted on behalf of each Hospital Group, aligned to one of the

seven named Clinical Research Facility/Centres (CRF/C’s) in Ireland (see section 5.1 for further details),

with applications being submitted through the associated HRB Host Institution (Academic partner).

Into the future, it is envisaged that support for Cancer Clusters will be merged into the HRB’s funding

support for Clinical Research Facilities as a specific cancer arm of the Clinical Research Facility, quality

permitting. This will ensure economies of scale, will avoid duplication and ensure continued consistent

governance for the conduct of safe and high-quality cancer clinical trials. The current model is designed

to enable this change in an incremental fashion.

Cluster applications must be made in partnership with a selected Cancer Clinical Lead and CRF/C

Director, with support from both the lead Hospital or Hospital Group CEO and a University Partner.

The HRB will contract directly with the nominated academic partner of each Cluster.

Clusters will be expected to:

• Partner with an academic host institution and local Clinical Research Facility/Centre based on

hospital group delineation

• Demonstrate a level of co-investment from the HSE/NCCP or other combination that is verifiable

in accounting terms

• Show a degree of strategic alignment with the regional integrated care organisations

• Demonstrate a previous track record of working together to develop and successfully deliver

cancer clinical trials over the previous funding period (2017-2020)

• Contribute to partnerships with Collaborative groups, Charities and Industry, as appropriate to

the portfolio


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• Provide expertise in the design, development, conduct and delivery of a portfolio of high-quality

clinical trials,

• Deliver a portfolio of trials within and or across the Clusters, supported by a well-functioning

referral system, to provide equitable access for all cancer patients to high quality cancer trials

• Deliver high-quality regulated and un-regulated trials, working closely with the Cancer Clinical

Trial Network as appropriate

• Avail of other clinical trial infrastructure supports (HRB-funded or otherwise) – e.g. clinical

research facilities/centres, HRB-Trial Methodology Research Network, new PPI Network etc.

• Use a centralised data management system, such as ‘CRF Manager’, aligned with other clinical

research infrastructures, for trial management and reporting

• Report all metrics as required by the HRB as a prerequisite for continued funding

• Train, educate and support all personnel working on clinical trials in the cluster aligned with

supports within existing clinical trials infrastructures.

3.2 National Cancer Clinical Trials Network

The scheme will provide support for an appropriate entity with a previous track record of providing

clinical trial services and supports to act as the national Cancer Clinical Trials Network, to provide

sponsorship oversight, support services and networking activities to the approved Clusters.

Applications for a national Cancer Clinical Trials Network must be submitted on behalf of a nominated

national Cancer Clinical Lead with the support of a recognised HRB Host Institution.

A National Cancer Clinical Trials Network will be expected to:

• Partner with an academic host institution

• Provide Governance support as Sponsor for the conduct of multicentre regulated cancer clinical

trials

• Provide Support services for studies including project management, database design and build,

clinical trial data management, data analysis, statistical analysis plans and reports, monitoring,

reporting and administration of trial activity at each approved cluster where required. They will

also be mandated to report on trial delivery and performance.

• Provide Networking support for Clusters to;

o Network and integrate at a national level the critical mass of expertise and resources

needed to provide Irish leadership in Investigator-led and commercial cancer clinical

trials

o Pro-actively establish and grow partnerships with Collaborative groups, Charities and

Industry, as appropriate to the portfolio of cancer trials

o Design and develop a portfolio of high-quality cancer clinical trials

o Ensure policies on the:


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▪ study selection and prioritisation for the network as a whole

▪ peer review of clinical trials which do not come with external competitive

funding e.g. commercial trials

▪ procedure and criteria for stopping trials within the cancer portfolio that is

maintained and implemented

▪ management of contributions from industry collaborators including a charging

model/list of fees for commercial studies

o Embed public and patient involvement in all cancer clinical trials

o Provide network support to all trial delivery teams at sites by providing a

communication platform for all members e.g. development of a community of practice.

3.3 Relationship with other clinical trials infrastructures

As we enter a new phase of investment in national clinical trials infrastructure, it is critical that

coordination and synergies are enhanced across the system to maximise the value of this investment.

Cancer trials infrastructures are expected to work with other clinical trials infrastructures within the

system to collectively improve patient access to clinical trials, integrate relevant best practices where

necessary to support national performance for the benefit of the Irish clinical trials system. These

include Clinical Research Facilities/Centres, Trials Methodology Research Network and the National

Clinical Trials Coordination Programme.

The National Clinical Trials Coordination Programme is expected to provide streamlined processes for

the conduct of multicentre clinical trials, such as the national feasibility programme, which is dependent

on local resources within other clinical trials infrastructures.

Dedicated resources will be supported through this call to work with, and contribute to, the National

Clinical Trials Coordination Programme. These personnel provide an underpinning link between the

clinical trials infrastructures and the National Clinical Trials Coordination Programme. They are

responsible for providing local data and information from the clinical trials infrastructure to the National

Clinical Trials Coordination Programme and for leading local implementation of measures to support

national alignment.

HRB expectations will be underpinned through special contractual conditions in relevant grant contracts

and will be a core element in ongoing assessment of grant performance of any subsequent award.

Applicants will have to set out how they propose to engage clinical trials infrastructures, and what plans

they have for the term of the award. Letters of Support/Infrastructure Agreement Forms from the

relevant clinical trials infrastructure will need to be provided at time of application clarifying how the

programme will engage with them for the term of the award.


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HRBs investment through this specific instrument will not support;

• funding for individual cancer clinical trials as it is expected that trials should come with

competitive funding from sources with effective independent international peer review, such as

the HRB Definitive Interventions and Feasibility Awards, other national/international funding

sources, international collaborative groups and / or industry-funded studies

• costs associated with routine patient care or translational studies, biobanks, patient registries

and questionnaires

• establishing new premises, including building work, or fit-out of buildings.

4 HRB Oversight and monitoring

4.1 HRB Clinical Trials Infrastructure Expert Advisory Group For independent oversight and strategic leadership, the HRB will appoint a Clinical Trials Infrastructure

Expert Advisory Group to oversee our investments in Clinical Trials Infrastructure from 2021 onwards.

The Expert Advisory Group will be established to help guide the HRB and the clinical trials community to:

• work towards integrating clinical trials within the health system to ensure that they are

delivered as part of usual care,

• raise the standards of the clinical trials environment and their conduct in Ireland whilst, and

• safeguarding the HRB’s investment of approximately €60 million in Clinical Trials Infrastructure

over the next five years.

The Expert Advisory Group will work with the HRB to review performance of all clinical trials

infrastructures on an ongoing basis and will be instrumental in implementing corrective action where

needed.

4.2 Award monitoring

Mandatory metrics will be established for the successful awards which will be used by HRB to monitor

progress. These key metrics will be agreed with the HRB prior to issue of award contract and aligned

with the HRB Clinical Research Facility/Centre and Clinical Trial Network funding calls. Clear reporting of

metrics will be a pre-requisite for continued funding, which will be monitored on an annual basis and

evaluated at an interim point. Mandatory metrics will include information about e.g. the number and

type of clinical trials, study start up, registration, recruitment levels - time to target vs. global

recruitment, reporting, networking activity, supports provided to the Clusters, changes to clinical

guidelines/practice, research articles, educational resources, reports, policy briefs and other relevant

documents.

Awardees will have to report on activity as part of the national feasibility programme of the National

Clinical Trials Coordination Programme as required. This will form part of the contractual obligations to


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the HRB. Awardees will also be expected to report activity in relation to participation in or leadership of

National Clinical Trials Coordination Programme Working Groups, and adoption of the outputs.

Furthermore, awardees will be expected to report activity in relation to work with other clinical trial

infrastructures, including HRB-TMRN, HRB-funded clinical trials networks, and the National PPI Network.

5 Funding and Duration of Awards

5.1 HRB Funding

Total HRB funding for this call will be up to a maximum of €4,175,000 per annum inclusive of overheads

over five years. The overhead contribution is aligned to research activity per application and aligns with

that paid to other HRB infrastructures;

• 30% overhead contribution for Cluster applications (in line with CRFs), and

• 25% overhead contribution for the National Cancer Clinical Trial Network application (in line

with other CTNs).

The funding split between the two calls is 65:35. With 65% of the overall funding going towards Cluster

applications and 35% going towards the National Cancer Clinical Trial Network.

The duration of the awards will be 60 months with an interim review.

5.1.1 Cluster funding

Total HRB funding will be up to a maximum of €2,713,750 per annum inclusive of overheads for all the

Cluster applications (including the Paediatric Cluster). The funding envelope per Cluster will vary

depending on the hospital group delineation (i.e. the number of hospital partners involved) and

previous performance. Therefore, awards will range between €150k to €500k p.a. over five years.

A portion of funds, approximately €500K per annum, is ringfenced for the Paediatric Cluster, which

includes resources to cover the governance activities currently carried out at OLHC.

It is recognised that Clusters scale, structure and levels of activity will differ therefore different levels of

investment are expected. Requests for support should be closely aligned with evidence of previous

performance and future plans. Budgets will be set out in a modular fashion, and it is possible that the

International Expert Panel will recommend funding for some modules but not others.

There will be a maximum of between 5 and 7 clusters, depending on budget available and quality of

applications.

The award will predominantly offer support for operational costs such as salary for core staff members

within the cancer delivery units, for example a Programme manager (Cluster manager), clinical trial


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nurses and data managers. As applications are made in partnership between the Hospital Group or

Hospital and University partner, most appointments are expected to be supported through Health

Service Executive contracts. However, applications are encouraged to consider a number of joint

appointments for Principal Investigators and core staff such as clinical research nurses to enable greater

integration of clinical research into the health system.

Eligible running costs include but are not limited to attendance at training events and centralised data

management systems, such as ‘CRF Manager’.

Co-investment for Clusters is a requirement of this call. Co-investment is required in the form of

support for core staff and/or in-kind contributions towards the operation of the Clusters, which will

need to be verifiable under accounting standards. Cluster applications must show evidence of co-

investment from academic, hospital and / or other partners. A matched funding ratio of 2:1 (HRB:

Partners) is expected i.e. for every €2 HRB investment a minimum co-investment of €1 from academic

partner, hospital group, individual hospital or other partner is required for the duration of the award.

We expect the following:

• between five to seven awards, budget and quality permitting,

• HRB funding cannot displace existing hospital funding; this existing investment should be

captured as co-investment,

• a minimum level of co-investment of 2:1 (HRB: Partners),

• clusters with lower levels of trial activity (based on registered clinical trials between 2017 and

2019) will be expected to bid for lesser amounts,

• all clinical trials infrastructures receiving funding from the HRB will be expected to support and

contribute to, the National Clinical Trials Coordination Programme and resources should be

assigned for that purpose, and

• awards will commence in January 2022 for a period of five years with continued funding based

on performance to agreed metrics over that funding period.

Funding will be awarded on a claims-made basis. Should the budget allocation for a period not be

claimed in full, the balance cannot be carried over and will be lost to the award (+/- 10% rule will be

applied). Therefore, it is important when developing the budget that applicants plan carefully in order to

draw down of the full amount awarded.

5.1.2 National Cancer Clinical Trial Network funding This award will run over 60 months and the maximum amount available will be €1,461,250 per annum

(inclusive of 25% overheads).


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Funding for sponsorship, support services and network activity are allowed, to drive a coherent network

and integrate at a national level, the critical mass of expertise and resources needed to provide Irish

leadership in Investigator-led and commercial cancer clinical trials.

The award will predominantly offer support for operational costs such as, but not limited to salary for

• core staff in database design and build, clinical trial data management, data analysis, statistical

analysis, monitoring etc.

• administration support and project management support for the central function, and / or

• clinical lead buy-out time to strategically lead the Network (maximum salary contribution of

€100K per annum).

Eligible running costs include but are not limited to a communication platform for all members, travel,

meeting costs and networking events.

We expect the following:

• one award will be made, quality permitting,

• Published process for access to supports, with clear assessment criteria, and clear cut-off dates

for access to supports where applicable.

• Published process for study selection and prioritisation for the network as a whole

• Published process for peer review of any studies which do not come with external competitive

funding.

• Policy on the procedure and criteria for stopping trials.

• Charging model/list of fees provided for industry studies

• all clinical trials infrastructures receiving funding from the HRB will be expected to support and

contribute to, the National Clinical Trials Coordination Programme and resources should be

assigned for that purpose, and

• award will commence in January 2022 for a period of five years with continued funding based on

performance to agreed metrics over that funding period.

6 Eligibility

6.1 Cluster(s) Application

Applications must be made on behalf of a team which is made up of a selected Cancer Clinical Lead,

CRF/C Director and Site Leads from each of the associated hospital sites, and submitted through a HRB

Host Institution5 on behalf of a Hospital Group aligned to one of the seven below-named Clinical

Research Facility/Centres (CRF/C’s) in Ireland.

5 The Host Institution (HI) for the HRB award must be a HRB recognised host institution. It is normally that of the

Lead Applicant, but it may be another organisation/institution designated by the applicant team, where it is clearly

justified. An up to date list of HRB recognised host institutions can be found at all times at:


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The seven named CRF/Cs and associated academic partners are;

1. Wellcome Trust-HRB-CRF at St. James Hospital in Dublin (hosted by Trinity College Dublin)

2. HRB-CRF Cork at the Mercy Hospital and Cork University Hospital (hosted by University

College Dublin)

3. HRB-CRF Galway at University College Hospital Galway (hosted by the National University of

Ireland Galway)

4. University College Dublin CRCs at The Mater Misericordiae University Hospital and St

Vincent’s University Hospital (hosted by University College Dublin)

5. Royal College of Surgeons in Ireland CRC at Beaumont Hospital (hosted by Royal College of

Surgeons in Ireland)

6. The Health Research Institute Clinical Research Support Unit at Limerick University Hospital

(hosted by University of Limerick)

7. Children’s Health Ireland (various hosting partners).

The applicant team should consist of Co-Lead Applicants, a Cancer Clinical Lead and a CRF/C Director,

and Co-Applicants (Site Leads) from each of the associated hospital sites within the application.

The Cancer Clinical Lead will serve as the primary point of contact for the HRB during the review process

and the duration of any subsequent contract. If successful, they will have overall responsibility for

delivery of the objectives of the Cluster and primary fiduciary responsibility and accountability for

carrying out the cluster activities within the funding limits awarded and in accordance with the terms

and conditions of the HRB. The division of responsibilities between the Co-Leads and Site Leads should

be clearly outlined within the application.

The Co-Lead Applicant(s) must:

• Hold a post (permanent or a contract that covers the duration of the award) in a HRB recognised

Host Institution in the Republic of Ireland (the “Host Institution”) as an independent

investigator. For clinicians, an adjunct position in a HRB recognised Host Institution is

acceptable, OR

• Be an individual who will be recognised by the Host Institution upon receipt of an award as an

independent investigator who will have a dedicated office and research space for the duration

of award, for which he/she will be fully responsible. The Co-Lead Applicant does not necessarily

need to be employed by the Host Institution at the time of the application submission.

The Site Leads as Co-Applicants have a well-defined, critical and substantial role in terms of assisting the

Co-Lead Applicants with the leadership and management of the proposed Cluster. Site Leads are

https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-approval-of-

host-institutions/

https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-approval-of-host-institutions/




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expected to spearhead the activities in their Site. There should be a Site Lead at each hospital site within

the Cluster (if applicable). The Co-Lead Applicant can also be the Site Lead for their hospital site.

The Site Lead must:




acceptable, OR



of award, for which he/she will be fully responsible. The Site Lead does not necessarily need to

be employed by the Host Institution at the time of the application submission.

They must show the capability and authority to manage and supervise the cancer trial delivery team at

their Site.

6.2 National Cancer Clinical Trials Network Application

Applications will be accepted from established entities with a previous track record of providing services

and supports for the conduct and delivery of high quality, safe and compliant cancer clinical trials.

Applications will need to be coordinated at a national level. This may take the form of letters of support

from host institutions, hospital groups, CRF/Cs, Chairs of the Cancer Disease Specific Sub-Groups and

other relevant stakeholders.

The Network Applicant Group is defined as the combined set of Network Lead and Co-Applicants that

submit a proposal for funding under the call. A Network Applicant Group should have as its basis a pre-

existing group based on previous services for multi-centre cancer clinical trial work.

The applicant team must designate a Network Lead (Lead Applicant) for the network, which must be a

Cancer healthcare professional practising in Ireland. The Network Lead will serve as the primary point of

contact for the HRB during the review process and the duration of any subsequent contract. The

Network Lead has primary fiduciary responsibility and accountability for carrying out the network

activities within the funding limits awarded and in accordance with the terms and conditions of the HRB.

The Co-Applicants have a well-defined, critical and substantial role in terms of assisting the Network

Lead with the leadership and management of the Network. Public and Patient Involvement contributors

are encouraged as Co-applicants or Collaborators as appropriate. The division of responsibilities

between the Network Lead and Co-Applicants should be clearly outlined within the application.

The Cancer Clinical Trials Network may also include collaborators for network activity. An official

Collaborator is an individual who is committed to providing a focused contribution for a specific task.


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The Collaborator will serve under the direction of the Network Lead or a Co-Applicant and may receive

funding through the award where justified. Involvement of a Collaborator should add value to the

network (e.g. act in an advisory capacity); facilitate patient input or involvement; or contribute to the

dissemination of the results of the research. Collaborators can be based in academic institutions, private

enterprise, healthcare organisations or agencies, or come from the charity sector. If involved in genuine

scientific collaboration, commercial partners may be included as official Collaborators. Commercial

Collaborators will, in general, be expected to meet their own costs unless well justified.

The terms of any collaboration should be determined early, and relevant agreements should be in place

ideally by the onset of the award for successful awards, but no later than six months following the start

of the award. The HRB advise that consideration must be given to issues such as relative responsibilities,

governance arrangements, intellectual property rights, reporting and publishing, and access to data and

samples when developing collaboration agreements.

All HRB Host Institutions must subscribe to “Ireland’s National IP Protocol 2019: A Framework for

Successful Research Commercialisation” prepared by Government/Knowledge Transfer Ireland to

ensure transparent and consistent procedures for managing Intellectual Property from publicly funded

research. https://www.knowledgetransferireland.com/Reports-Publications/Ireland-s-National-IP-

Protocol-2019-.pdf

The Network Lead must:




acceptable, OR



of award, for which he/she will be fully responsible. The Co-Lead Applicant does not necessarily

need to be employed by the Host Institution at the time of the application submission.

The Network Lead must show evidence of achievement as an independent researcher in their chosen

research field by:

a) Demonstrating a record of research output, with at least three publications of original research

in peer reviewed journals and/or evidence of expertise in conducting trials matched to the

nature and context of the project. Where appropriate, they should also provide evidence of

other outputs such as published book chapters, reports to government and/or any other

relevant outputs that have resulted in a significant impact in their field.

b) Demonstrating a record of independence by showing that they have secured at least one peer-

reviewed research grant for a research project/s, as either the Lead Applicant or a Co-Applicant.

Funding received for travel to seminars/conferences and/or small personal bursaries will not be

considered in this regard.

https://www.knowledgetransferireland.com/Reports-Publications/Ireland-s-National-IP-Protocol-2019-.pdf

https://www.knowledgetransferireland.com/Reports-Publications/Ireland-s-National-IP-Protocol-2019-.pdf



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c) Show evidence that they possess the capability and authority to manage the network applicant

group.

Note: The Network Lead cannot act as a Cluster Lead, but they can act as a Site Lead within a Cluster

application.

6.3 Host Institution

The Host Institution (HI) for the HRB award must be a HRB recognised host institution. It is normally that

of the Network Lead (Lead Applicant), but it may be another organisation/institution designated by the

network applicant team, where it is clearly justified. An up to date list of HRB Approved Host Institutions

can be found at http://www.hrb.ie/research-strategy-funding/policies-guidelines-and-grant-

conditions/policies-and-position-statements/approval-of-host-institutions/.

7 Governance

HRB expects that both the Cluster and the national Cancer Clinical Trials Network applications will set

out appropriate governance arrangements that will form part of the award contract. Governance

structures should cover strategic and scientific oversight, reporting relationships, management and

external independent advice. The relationships and arrangements to support this should be clarified in

the applications.

8 Trial Registration and Reporting The HRB is a signatory of the AllTrials campaign (http://www.alltrials.net/) and supports the aim of

having all trials registered and all results reported. We extend this ambition to all interventions funded by

the HRB, as well as trials delivered by networks funded by the HRB. Therefore, and aligned to the HRB

Clinical Trials and Interventions Research Governance Policy6 we will require all interventions carried out

by HRB-funded clinical trials infrastructures to be registered in a publicly accessible register prior to

initiation of the study, as part of their contractual obligations. Results must be reported on the register

within twelve months of completion of the intervention. The HRB also expects that results (positive and

negative) of the intervention will be submitted for publication. These results must be posted to the results

section of the clinical trial registry where the trial was originally registered.

6 https://www.hrb.ie/fileadmin/1._Non-plugin_related_files/RSF_files/Policies_and_principles/Grant_Policies/HRB_Policy_on_Clinical_Trials_and_Interventions_Governance.pdf

http://www.hrb.ie/research-strategy-funding/policies-guidelines-and-grant-conditions/policies-and-position-statements/approval-of-host-institutions/

http://www.hrb.ie/research-strategy-funding/policies-guidelines-and-grant-conditions/policies-and-position-statements/approval-of-host-institutions/

http://www.alltrials.net/


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9 FAIR Data Management and Stewardship

Data management/stewardship plans (DMP) are nowadays widely accepted as part of good research

practice. The HRB supports open research7 and open publishing directly through the HRB Open

Research Platform8. The HRB are driving the making of research data FAIR (Findable, Accessible,

Interoperable and Re-usable) in order to benefit science by increasing the re-use of data and by

promoting transparency and accountability. The FAIR data principles9 provide a guideline for those

wishing to enhance the re-usability of their data holdings: these principles put specific emphasis on

enhancing the ability of machines to automatically find and use the data, in addition to supporting its re-

use by individuals.

For researchers, the move to FAIR and open data means researchers should consider data management

issues and identify suitable data repositories at the research planning stage. Applicants will have to

provide information about their plans for data management and data sharing at application stage.

10 Public and Patient Involvement (PPI) in research The HRB Strategy 2016-2020, Research. Evidence. Action., refers to Public and Patient Involvement (PPI)

as a core principle of research and contains the commitment to strengthen and develop PPI within the

HRB and in HRB-supported projects and programmes. The HRB is the first public funding agency in

Ireland to do so. The development of the next HRB Strategy 2021-2030 is progressing and putting the

public at the heart of the research that the HRB funds is emerging as a key theme.

The HRB is using the definition of PPI proposed by INVOLVE: Research carried out ‘with’ or ‘by’ members

of the public rather than ‘to’, ‘about’ or ‘for’ them. The HRB promotes the active involvement of

members of the public in the research that we fund10. Public involvement is distinct from and additional

to activities that raise awareness, share knowledge and create a dialogue with the public and it is also

distinct from recruitment of patients/members of the public as participants in research.

'Public involvement' represents an active partnership between members of the public and researchers in

the research process. This can include, for example, involvement in the choice of research topics,

assisting in the design, advising on the research project or in carrying out the research.

PPI contributors should be actively involved and part of decision making. Involving members of the

public in research can improve quality and relevance of research. It can:

7 http://www.hrb.ie/funding/policies-and-principles/open-research/ 8 https://hrbopenresearch.org/ 9 https://www.force11.org/group/fairgroup/fairprinciples 10 http://www.hrb.ie/funding/funding-schemes/public-and-patient-involvement-in-research/

http://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-open-access/

https://hrbopenresearch.org/

https://hrbopenresearch.org/

https://www.go-fair.org/fair-principles/


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• provide a different perspective - even if you are an expert in your field, your knowledge and

experience will be different to the experience of someone who is using the service or living with

a health condition,

• make the language and content of information such as questionnaires and information leaflets

clear and accessible,

• help to ensure that the methods proposed for the study are acceptable and sensitive to the

situations of potential research participants,

• help to ensure that the research uses outcomes that are important to the public,

• identify a wider set of research topics than if health or social care professionals had worked

alone, and

• help you increase participation in your research by making it more acceptable to potential

participants.

In addition to improving relevance and quality of research, it ensures that research is influenced by

broader principles of citizenship, accountability and transparency. PPI is an ethos as well as a practice. It

should be context-specific and should aim to ensure that all voices are heard. Where members of the

public or patients are involved, they must be compensated for their time and contributions.

During 2020, the HRB together with the Irish Research Council invited an application for a National PPI

Network, with local sites across Ireland. The new National PPI Network will be awarded in March 2021.

In the application, you are asked to describe how your clinical trials infrastructure will support

researchers’ PPI activities during the development of an application and during the conduct of a cancer

clinical trial.

PPI should play a critical role in cancer clinical trials. If there is currently no PPI strategy within the

national Cancer Clinical Trial Network this is an opportunity to develop an approach to embed PPI within

the work of the national network.

11 General Data Protection Regulation

The General Data Protection Regulation (GDPR) came into force on 25 May 2018. As a result, the

applicant teams will be asked through the HRB Grant E-Management System (GEMS) to consent that

personal data provided as part of this application, including but not limited to CV information, may be

shared with person(s) based outside of the European Economic Area (EEA) for the specific purpose of

obtaining panel reviews of this application. International reviewers play a vital role for the HRB in setting

standards and in benchmarking our scientific community to enable them to operate in a global context.

Panel reviewers are selected for their specific expertise in relation to submitted application and can be

based anywhere in the world.

Furthermore, by confirming participation, you will be asked to consent that the HRB uses the

information you provide (regarding all applicant team members) to consider your application, contact


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you about your application, and if you are successful, to manage your grant throughout its lifetime in

accordance with general T&C for research awards. This will include contacting you with regard to

monitoring of progress through written reporting and other means e.g. interim review. We will publish

some basic information on successful awards including PI, Host Institution, amount awarded and lay

summary on our website and may highlight individual awards or researchers in more detail (with specific

consent). We will also use the information you have provided to generate general statistics around our

current funding portfolio, and to evaluate our funding mechanisms and investment. After your grant has

ended, we will continue to keep your information on file (in accordance with HRB policies) to allow us to

evaluate the outcomes, outputs and impacts of HRB investment in your research.

Please note that we will also use information associated with unsuccessful applications for a number of

the purposes outlined above such as generating general statistics around our current funding portfolio,

and to evaluate our funding mechanisms and investment e.g. demographics of applicants, research

areas of applicants. Similarly, we will use the information provided about people employed on awards to

help evaluate our career support and capacity building initiatives.

12 Application, Review Process and Assessment Criteria The HRB is committed to an open and transparent process underpinned by quality, excellence and international peer review. To ensure the integrity of the assessment process, conflict of interest and confidentiality are applied rigorously at each stage of the process.

12.1 Grant E-Management System (GEMS)

All applications must be completed and submitted through the HRB online Grant E-Management

System (GEMS) (https://grants.hrb.ie). GEMS will close automatically at 1pm on Friday 15 January

2021.

The applications must have been reviewed and approved by the signatory approver at the research

office (or equivalent) in the host institution before it is submitted to the HRB. Therefore, applicants

should ensure that they give the signatory approver enough time before the scheme closing date to

review the application and approve it on GEMS. Please note that many host institutions specify internal

deadlines for this procedure.

12.2 Gender Policy

The HRB Gender Policy came into effect on 1 June 201611. In line with international best practice the

HRB has a responsibility to support both women and men to realise their full potential in order to

ensure equality of opportunity and to maximise the quantity and the quality of research. To ensure

11 http://www.hrb.ie/research-strategy-funding/policies-guidelines-and-grant-conditions/policies-and-position-statements/gender-policy/



20

fairness and equality to all applicants, each funding application received will be assessed as outlined in

the call guidance documentation for that particular funding round.

To ensure gender balance in decision-making, the HRB aims to reach the international best practice

target of 40% of the under-represented sex in all HRB panels where possible. Gender will also be

considered when appointing the position of Panel Chair.

Submitted applications will first be checked for eligibility by HRB staff against the minimum

requirements for this scheme: both eligibility of the team, as well as minimum requirements expected of

the Cluster and Network. Eligible applications will undergo a Panel assessment process as detailed

below.

12.3 Selection Panel

The Panel will comprise of an independent Chair and six to ten members. It is envisaged that some will

have served on previous HRB Panels. Panel members are selected based on the expertise and skillset

required.

Panel members will be assigned to review each application, and provide preliminary written feedback, in

addition to an initial score according to the agreed assessment criteria.

Interviews

Co-Lead Applicants/Network Lead and key team members will be invited to attend an interview. Initial

comments or questions from the international Panel will be provided to the Co-Lead

Applicants/Network Lead prior to the interview. This will provide the Co-Lead Applicants/Network Lead

and their team with an opportunity to address the key comments, suggestions, misconceptions, etc.

during the interview. The names of the Panel members will be provided to the candidates a few days

before the interview meeting.

The interview will begin with a short presentation by the applicant team followed by a Q&A session

where the applicant team should aim to address any concerns raised by Panel members. More details

on the interview will be provided to the applicant team closer to the time. The Panel will make a

recommendation to the HRB at the end of the meeting. The recommendations by the Panel will be

submitted to the Board of the HRB for approval.

The Panel will assess all applications based on the following assessment criteria, which have equal

weight. Successful applications must score highly in all criteria.

12.4 Review criteria The assessment criteria are equally weighted, and successful applications are expected to perform

highly on all;


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12.4.1 Clusters

• Strategic direction and Business plan - The extent to which the proposed activities and the

anticipated outputs and outcomes will ensure increased patient access to high quality clinical

trials.

• Operational Model - accessibility, referral system, inclusiveness and linkage to the national

cancer clinical trial network for study selection and supports.

• Governance structures and arrangements are appropriate.

• Expertise and fit of teams, including Leadership.

• Expertise and track record of team in delivering high quality clinical trials. The quality and

volume of cancer clinical trials undertaken within the Cluster.

• Support from the Host Institution, Clinical Research Facility/Centre and Hospital group or

Hospitals, as demonstrated through the level of co-investment and the appropriateness of the

facilities and supports made available to them to conduct these studies.

12.4.2 National Cancer Clinical Trials Network

• Strategy - the extent to which the proposed activities and the anticipated outputs, outcomes

and impacts on patients and/or public health and wellbeing and/or health care. How are cancer

trials prioritised, selected and conducted to ensure high quality cancer clinical trials.

• Business plan for the term of investment.

• Governance structures and arrangements are appropriate.

• The strength of the strategic partnerships, including those with industry, universities, and other

HRB-funded research infrastructure.

• Quality of proposed network and trials activities.

• Relevance for the academic and healthcare practitioner research community.

• Team and environment.

13 Conflict of Interest

Conflict of interest rules are applied rigorously. Where a conflict of interest exists, the reviewer is

requested to inform the HRB immediately so that an alternative reviewer may be appointed. International

peer reviewers will not provide comments or scores on any application on which they have a conflict of

interest.

Reviewers must adhere to high standards of integrity during the peer review process. They must respect

the intellectual property of applicants and may not appropriate and use as their own, or disclose to any

third party, ideas, concepts or data contained in the applications they review.


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14 Timeframe

Activity Timeline

Call Open

04 August 2020

Closing date

15 Jan 2021

Review period

Jan-mid March 2021

Panel meeting

April 2021

Recommendations to HRB Board

June 2021

Award Start Date

01 January 2022

The deadline for submission of applications through GEMS is Friday 15 January 2021 by 13:00 pm

15 Contact For further information on cancer trials in Ireland contact:

Amie Regan Oonagh Ward

Project Officer Programme Manager

Health Research Board Health Research Board

e [email protected] e [email protected]

It is the responsibility of the Lead Applicants to upload all supporting documentation prior to

submission. If the documentation is not received by the HRB on time, in the correct format or is not

properly signed or submitted, the application will be deemed ineligible without further review.

The HRB reserves the right to reject any application that does not meet the terms of this call. The

decision of the HRB Board in respect of any grant application is final and cannot be appealed or

reviewed.

The HRB’s procedure for appealing funding decisions is available at http://www.hrb.ie/funding/funding-schemes/before-you-apply/relevant-policies/

mailto:[email protected]

http://www.hrb.ie/funding/funding-schemes/before-you-apply/relevant-policies/


23

Appendix I: Detailed Guidance on the Application Form for Clusters

Only registered users of the GEMS system can apply for grants. In order to submit an online application

to the HRB, applicants are required to register at the following address:

https://grants.hrb.ie

Please refer to the GEMS Technical Guidance Note for further information.

Applications must be submitted on behalf of a team which is made up of a selected Cancer Clinical Lead,

CRF/C Director Co-Lead and Site Leads from each of the associated hospital sites and submitted through

an approved HRB Host Institution.

The Cancer Clinical Lead Applicant must create the application, but it can then be jointly completed with

the named CRF/C Director Co-Lead and Co-Applicants (Site Leads).

• Applications will be submitted on behalf of a team; lead by the Cancer Clinical Lead

Applicant and the CRF/C Director Co-Lead.

• The Cancer Clinical Lead Applicant must take on the role of submission to GEMs; their CV

and contact details will be pulled through from GEMs.

• The CRF/C Director Co-Lead Applicant must enter their details manually. The CRF/C Co-Lead

must review and approve the application prior to submission.

• Applicants can register on GEMS and they will receive an email to confirm their registration

and log in details. The Lead Applicant can then add information on their contact and CV

details in ‘Manage My Details’ section of GEMS.

• Applicants previously registered on GEMS can login to GEMS and update any information

regarding their contact and CV details in ‘Manage my details’.

Once logged in to GEMS applicants are taken directly to the Home page which is the starting point to

create a new Grant application.



Once the Cancer Clinical Lead Applicant selects the ‘Cancer Trials in Ireland- Network Application’

scheme on GEMS, s/he will be asked to confirm their agreement to share personal data in the

application.

The Cancer Clinical Lead Applicant will be then able to start the application.

Further details for completing each of the main sections of the application form are provided below:



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Cancer Clinical Lead Applicant Declaration

Agreement to share personal data in application

I understand that personal data provided as part of this application, including but not limited to CV

information, may be shared with person(s) based outside of the European Economic Area (EEA) for the

specific purpose of obtaining peer reviews of this application. Y/N

CRF Director Co-Lead Applicant Declaration





1 Host Institution and Signatory Notification

1.1 Host Institution

The Host Institution (HI) for the HRB award is a HRB recognised host institution. This is normally that of

the Lead Applicant, but it may be another organisation/institution designated by the research team,

where it is clearly justified. An up to date list of HRB recognised host institutions can be found at all

times at: https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-

policy-on-approval-of-host-institutions/

Applications must be submitted through a recognised HRB Host Institution on behalf of a Hospital

Group aligned to one of the following Clinical Research Facility/Centres in Ireland;

1. Wellcome Trust-HRB-CRF at St. James Hospital in Dublin (hosted by Trinity College Dublin)

2. HRB-CRF Cork at the Mercy Hospital and Cork University Hospital (hosted by University

College Dublin)

3. HRB-CRF Galway at University College Hospital Galway (hosted by the National University of

Ireland Galway)

4. UCD CRCs at The Mater Misericordiae University Hospital and St Vincent’s University

Hospital (hosted by University College Dublin)

5. Royal College of Surgeons in Ireland CRC at Beaumont Hospital (hosted by RCSI)

6. The Health Research Institute Clinical Research Support Unit at Limerick University Hospital

(hosted by University of Limerick) and

7. Children’s Health Ireland (various hosting partners).




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A list of the Host Institutions approved by the HRB at the time of this call going live is included as a PDF

on GEMS. In GEMS you will be asked to identify a Host Institution (from this list) and type it in full (do

not use acronyms such as UCD, TCD, NUIG). Once you have entered the first 3-4 characters of the HI,

you will be assisted with auto-select options. It is important that the HI name is entered in accurately

and in full, as an incorrect entry may result in delays attaining HI approval.

Note: In order to be eligible to apply for funding, an Institution must have been approved as a HRB Host

Institution no later than two calendar months before the closing date of a call, only pre-approved HIs

will appear in this list.

1.2 Signatory Notification (within Host Institution)

Once the Host Institution is selected at the initial stages of application creation this will allow the Lead

Applicant to notify the authorised signatory (Dean of Research or equivalent person authorised to

endorse research grant applications for the Host Institution) in that Host Institution of the Lead

Applicant’s intention to submit an application to the Cancer Trials in Ireland Call. The signatory’s details

are pre-populated in the system so the applicant just needs to click ‘NOTIFY’ within GEMS. We

recommend that you notify the HI signatory of your intention to apply as soon as possible in the

application process. The signatory will receive an email from GEMS with the name and email details of

the Lead Applicant and if they have any queries or clarifications they can engage directly to resolve them

with the Lead Applicant. The HI signatory must confirm their willingness to participate as HI for the

application through GEMS and once they do this a PDF of the application will be available for them to

review with a view to them ultimately approving the final version for submission to the HRB.

2 Cluster Overview

2.1 Cluster Name and Membership

The Lead Applicant and Co-Lead will be asked to name the members of the cluster including:

- Hospital sites involved (and site leads)

- Hospital group

- CRF/C

- Host institution

Multiple hospital sites may be listed in the same text box, separated by a comma.

2.2 Cluster Duration and Start date

Please indicate the expected start date. Please note that awards are 60 months in duration and all

awards are expected to commence during January 2022. Please note that the earliest start date will be

01 January 2022.


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2.3 Cluster Summary

Please provide a summary of the proposed activities of the Cluster and how they might contribute to the

provision of equitable access for all cancer patients to high quality cancer clinical trials across the island

of Ireland. Please also describe how this Cluster sits within the national context. The word limit is 500

words.

2.4 Lay Summary

Please provide a lay summary of the Cluster and its proposed activities. The lay summary needs to be

written as a plain English summary, such that it is a stand-alone document that is clear, easy to

understand, and is easily accessible to a broad lay audience. Avoid the use of highly technical terms. This

summary may be used when providing information to the public concerning the variety of research

funded by the HRB. The word limit is 300 words.

2.5 Cluster Infrastructure Support

Describe the infrastructure, facilities, specialist expertise and other support available at the Host

Institution and/or at other sites in the Cluster to carry out cancer clinical trials. Please give an overview

of salary supports and other direct financial supports provided from the Hospitals and Host Institution

and indicate duration of the support. Please include details of additional institutional supports in areas

such as business development, legal, marketing expertise where this is being provided above and

beyond the activities/expertise of members of the Cluster team.

What is the planned level of support and integration between sites within the Cluster?

If successful in this award what levels of infrastructure will be required for the successful delivery of the

proposed business plan? What reorganisation will be required to fulfil these requirements?

The word limit is 500 words.

3 Cluster Description

Please ensure that your application is focused, and that sufficient evidence is provided to enable the

international selection panel to reach a considered judgement as to how the proposed Cluster meets

each of the assessment criteria.

In addition to this there are a number of expectations set out in the guidance notes for Cluster. Please

ensure that you describe how this application will be used to meet the expectations of a Cluster under

the call for cancer trials in Ireland.

Clusters will be expected to:


27

• Partner with an academic host institution and local Clinical Research Facility/Centre based on

hospital group delineation

• Demonstrate a level of co-investment from the HSE/NCCP or other combination that is verifiable

in accounting terms

• Show a degree of strategic alignment with the regional integrated care organisations

• Demonstrate a previous track record of working together to develop and successfully deliver

cancer clinical trials over the previous funding period (2016-2019)

• Contribute to partnerships with Collaborative groups, Charities and Industry, as appropriate to

the portfolio

• Provide expertise in the design, development, conduct and delivery of a portfolio of high-quality

clinical trials,

• Deliver a portfolio of trials within and or across the Clusters, supported by a well-functioning

referral system, to provide equitable access for all cancer patients to high quality cancer trials

• Deliver high-quality regulated and un-regulated trials, working closely with the Cancer Clinical

Trial Network as appropriate

• Avail of other clinical trial infrastructure supports (HRB-funded or otherwise) – e.g. clinical

research facilities/centres, HRB-Trial Methodology Research Network, new PPI Network etc.

• Use a centralised data management system, such as ‘CRF Manager’, aligned with other clinical

research infrastructures, for trial management and reporting

• Report all metrics as required by the HRB as a prerequisite for continued funding

• Train, educate and support all personnel working on clinical trials in the cluster aligned with

supports within existing clinical trials infrastructures.

3.1 Vision and Mission

Please state the vision and mission of the Cluster, that includes the period 2022 - 2026. The word limit is

50 words

3.2 Strategic Direction

Briefly describe the strategic position of the Cluster. Detail key opportunities and strategic challenges for

the Cluster. Please describe the strategic objectives aligned with the vision and mission including

details of planned strategic alignment with the following:

- National Cancer Strategy 2017-202612,

- National Cancer Clinical Trials Network

- CRF/Cs

- regional integrated care organisations

- other collaborative groups, charities and industry as appropriate to the portfolio.

12 https://www.gov.ie/en/publication/a89819-national-cancer-strategy-2017-2026/

https://www.gov.ie/en/publication/a89819-national-cancer-strategy-2017-2026/


28


3.3 Management, Governance and Strategic Oversight

Provide a high-level description of the oversight, advisory or governance structures that will be put in

place for the Cluster. Please provide details about any reporting relationship with the HI/Hospital

Groups, Clinical Research Facility/Centre, and external governing bodies as appropriate. Include details

of Governance Board, Scientific Advisory Boards and any other committees as applicable, including the

scientific advisory groups of the national cancer clinical trial network (please detail

role/membership/frequency of meetings).

The Clusters and the National Cancer Clinical Trials Network are also expected to cooperate fully with

any HRB Clinical Trials Infrastructure Expert Advisory Group. This Expert Advisory Group is anticipated

to assist the HRB in the strategic oversight and performance monitoring of the Infrastructures,

networks and Interventions portfolio.


3.3.1 Organogram (mandatory upload)

Please include an organisational chart/organogram to illustrate the Cluster structure, management and

governance using the file upload option on GEMS.

3.4 Operational model

Describe the operational model which supports the cancer clinical trial portfolio at your Cluster. Please

describe how the current operational model is appropriate to the stage and scale of the proposed

activities.

3.4.1 Key Policies and Processes

Briefly describe key policies and processes. Please include references to patient flow and population,

accessibility, referral system, inclusiveness and linkage to the national cancer clinical trial network for

study selection and supports to deliver high quality regulated and un-regulated cancer clinical trials.


In the context of the Paediatric Cluster application or applications associated with the Paediatric Cluster

– please describe how adolescent/young adults patient populations will be addressed.



29

You may embed links to key policies and SOPs.

A file upload option is available to include an attachment to support your operational model description.

A maximum of 8 figures, which can be a combination of images, graphs, tables, scales, instruments or

surveys, may be uploaded as a single document on HRB GEMS. They must not be embedded within the

text of the operational model description. The maximum size is 2MB.

3.5 Financial Management support for Cluster

Please provide details about the financial management processes to manage Cluster income and

expenditure. Please include information on accounts to be used, processes such as invoicing, and

processes to enable income and expenditure to be reported on an annual basis.


3.6 Clinical Research Infrastructure Agreement Form (mandatory upload)

A Clinical Research Infrastructure Agreement Form must be completed for each Cluster and can be

downloaded from GEMS. The Form must be completed, signed, dated and uploaded on GEMS.

Electronic signatures are acceptable for letters/forms that are uploaded on GEMS.

4 Cluster Clinical Trial Performance to date

4.1 Registered clinical trials activity

Please list all registered cancer clinical trial activity at the Cluster from 1 Jan 2017 to 31 Dec 202013 from

earliest to most recent, in the accompanying Metrics Excel spreadsheet template. A full explanation of

terms is given in the “Clinical Trial Data Reference” document.

Please note that only registered trials can be captured in the spreadsheet. If there are multiple

registration numbers, please quote the ClinicalTrials.gov registration number.

Please upload the completed Excel spreadsheet to GEMS using the available upload function.

13 Due to the later submission date of January 2021 for this call, we are asking for registered clinical trial data up to 31 December 2020 to give a better picture of recent activity. We recognise that the data for this year may appear as an outlier due to the impact of Covid-19, however the HRB and the Panel will recognise this


30

4.2 Cancer Clinical trials: graphical analysis

As an overview of the Clusters clinical trials portfolio please upload a single two-page document

comprising 4 graphs of trial data from 1 Jan 2017 to 31 Dec 2020 from the spreadsheet, displaying:

a. All registered trials during period broken down by phase “Column H”

b. All registered trials during period broken down by disease area “Column L”

c. All registered trials during period broken down by Sponsor i.e. Industry v Academic v Cancer

Trials Ireland sponsored (2017-2020)

d. # of registered trials commencing recruitment14 at each site within the Cluster each year during

period 2017-2020

See example available for download on GEMS for format of graph to be used, for ease of comparability

for the reviewers.

Please upload the graphs in word document/PDF format to GEMS using the available upload function.

4.3 Trial portfolio performance

Please detail the approach of the Cluster to the measurement of performance of individual trials and of

the portfolio overall. Give details of those performance metrics in the period 1 Jan 2017 – 31 Dec 2020,

such as but not limited to start up speed15 and recruitment reliability16, and note improvements in same

over time.

In addition, please provide the following detail:

- The tools and software packages used to aid performance monitoring

- the person(s) responsible for the collection and collation of such data

- changes in data collection process and procedures that the Cluster may use to improve the

collection and reporting of data


4.3.1 Do you have a policy on the procedure and criteria for stopping trials?

If yes, please upload to GEMS using the available upload button.

4.4 Summary of recent achievements

14 The period after all approvals have been obtained and site green light has been issued 15 Start up speed- median number of days from receipt of protocol to regulatory approval or ethical approval 16 Recruitment reliability – number of actual participants randomised as % of number planned per study


31

Please give brief details (bullet points preferred) to give an idea of recent achievements in the Cluster

and key areas of cancer clinical trial activity with a brief description of the role of Cluster staff in each

case. Areas to cover may include: key cancer clinical trials attracted to Ireland, healthcare innovations

tested, clinical guidelines, policy and practice influences, education/capacity building, IP and commercial

developments.


5 Cluster Business Plan 2022-2026

5.1 Proposed Business Plan

Summarise the overall business plan that will achieve the strategic objectives of the Cluster highlighting

how current studies will be managed and completed and how future studies will be designed,

developed, selected and supported throughout their lifetime.


5.1.1 Work package details

Please add a number of work packages which map to the relevant strategic objectives and detail how

they will integrate to deliver a coherent portfolio of high-quality cancer clinical trials including plans to

train, educate and support all personnel.

Each work package should include objectives, deliverables and milestones which will be finalised during

contract negotiations, as informed by the international review panel. Final deliverables will form part of

the contract should you be successful and will be used by the HRB for monitoring of the progress of the

award, in addition to agreed performance metrics

Work Packages should be mapped against estimated completion timelines in a Gantt chart, and any

milestones highlighted. In addition, please detail the resources and staff required for each work package

within the description of the work package All staff included in the application budget must be

associated with a work package in this section.

The Clusters are expected to integrate with other clinical trial infrastructures nationally to collectively

improve patient access to clinical trials, integrate relevant best practices where necessary to support

national performance for the benefit of the Irish clinical trials system. These include a National Cancer

Clinical Trial Network, National Clinical Trials Coordination Programme and HRB Trials Methodology

Research Network. Activity and resources should be assigned for that purpose. Ideally this should be a

distinct work package pertaining to coordination.


32

The word limit is 150 words for each Work Package description, 200 words for the tasks and

deliverables and a further 200 for resources and staffing.

5.1.2 Gantt Chart (mandatory upload)

You must upload a Gantt chart that lists the above Work Packages, tasks and deliverables against the

estimated timelines for completion, together with any additional milestones/key dates (example in

Figure 1).

Figure 1: Example of Gantt chart template available from the HRB.

Please upload using the available upload option.

5.1.3 Staff resources Briefly summarise the staffing resources (to be funded by HRB and other sources) required to deliver the Work packages above (aligned to the table of staff as requested in section 7.5). Please note the Work package lead in each case. The word limit is 400 words.

5.2 Other Collaborations and Partnerships

Please provide a brief summary of plans for the development of collaborations and partnerships. Outline

any existing or planned collaboration, stating clearly if it as a local, regional, national or international

activity. The word limit is 1000 words.


33

5.3 Patient and Public Involvement

PPI should play a critical role in clinical trials. Applicants are asked to describe how the Cluster will work

with a national Cancer Clinical Trial Network to develop an approach to embed PPI with cancer clinical

trials The word limit is 200 words.

5.4 Equality, diversity and inclusion

Equality, Diversity and Inclusion should be considered throughout your Cluster proposal. Please identify

and explain how you address Equality, Diversity and/or Inclusion in the Cluster.


5.5 Potential Risks and Ethical Concerns

Please address any potential risk and/or harm to the safety of the patients or human

subjects/participants in the network, if relevant; and highlight any potential ethical concerns, even if not

part of this application, and how you propose to deal with them. The word limit is 300 words.

5.6 Dissemination and Knowledge Exchange Plan

Include a clear dissemination and knowledge exchange plan to indicate how the outputs you anticipate

producing during the current investment will be disseminated, shared and made openly accessible, in

line with HRB Open Access Policy17. Outputs include peer-reviewed publications, non-peer reviewed

publications and conference proceedings, reports, policy briefings, guidelines, training materials and so

on. Protection of Intellectual Property should be considered before data are disseminated18.

1. The HRB has a mandatory Open Access publication policy; demonstrate how you plan to make

all publications open access.

2. Who are the various audiences and communities that need to be targeted if these results are to

have any impact? What is your dissemination plan to address this, how will these audiences be

reached?

17 http://www.hrb.ie/research-strategy-funding/policies-and-guidelines/policies/open-access/ 18 All HRB Host Institutions must subscribe to the National Intellectual Property Protocol, ‘Inspiring Partnership- the national IP Protocol 2016: Policies and resources to help industry make good use of public research in Ireland’, prepared by Government/Knowledge Transfer Ireland to ensure transparent and consistent procedures for managing Intellectual Property from publicly funded research.

http://www.hrb.ie/research-strategy-funding/policies-and-guidelines/policies/open-access/


34

3. Describe how the findings of this research are to be publicised to the HSE, government

departments or international health community/organisations in a manner that will optimise

impact on health policy and/or practice.

4. Please reference aspects of the project/study undertaken to maximise chances of adoption

beyond the term of the award.

Types of publication routes19:

• Green Route: publishing in a traditional subscription journal. Articles are ‘self-archived’ (added)

to a repository (institutional or external subject-based) and usually made available after an

embargo period, which is set by the publisher.

• Gold Route: publishing in an open access or hybrid journal. Articles processing charges (APCs)

are paid so that the article is openly available immediately on publication and can be added to a

repository (institutional or external subject-based).

• HRB Open Research: rapid open-peer reviewed and open access platform for all research

outputs, with all publication charges covered centrally by the HRB at no expense to the grantee.

(www.hrbopenresearch.org).


5.7 FAIR Data Management

Describe the approach to data management that will be taken during and after the project, including

who will be responsible for data management and data stewardship. Please consider the FAIR Guiding

Principles for scientific data management and stewardship: Findability, Accessibility, Interoperability,

and Reusability20. Please consider issues such as the types, volume and format of data, and what data

will be collected, processed or generated. Consider what metadata and documentation will accompany

the data. Will there be a globally resolvable, unique, persistent identifier (such as DOI)? What data

quality control measures will be used? Please consider how data will be stored and backed up. How will

data security be addressed? How and when will you share the data? How will you select data for

preservation and where data will be preserved long term (e.g. data repository, archive). What methods

or software tools will be required to access data? Who will be responsible for data management (e.g.

data steward) and the time needed for data management and for making data FAIR (costs may be added

under the budget section). Where it is envisaged that a Data Management Plan (DMP) will be created

during the project please indicate this and include delivery of the DMP and any planned revisions within

the project deliverables. The word limit is 500 words

5.8 Compliance with GDPR

19 Source: https://www.jisc.ac.uk/guides/an-introduction-to-open-access 20 Wilkinson, M. D. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci. Data 2016 3:160018 doi: 10.1038/sdata.2016.18

http://www.hrbopenresearch.org/

https://www.jisc.ac.uk/guides/an-introduction-to-open-access


35

Please comment on how your proposed Cluster complies with The General Data Protection Regulation

(EU) 2016/679, if relevant, especially where execution of study activity involves the transfer of data

outside of the EU. The word limit is 200 words.

6 Project Budget

Project Budget

The budget requested from the HRB must be matched by the stated level of co-investment from the

HI/Hospital and or other partners.

Total HRB funding will be up to a maximum of €2,713,750 per annum inclusive of overheads for all the

Cluster applications (including the Paediatric Cluster).

The funding envelope per Cluster will vary depending on the hospital group delineation (i.e. the number

of hospital partners involved) and previous performance. Therefore, awards will range between €150k

to €500k per annum over five years. Requests for support should be closely aligned with evidence of

previous performance and future plans.

A portion of funds, approximately €500K per annum, is ringfenced for the Paediatric Cluster, which

includes resources to cover the governance activities currently carried out at OLHC.

Note: Funding will be awarded on an annual claims made basis. Should the budget allocation for a

period not be claimed in full, the balance cannot be carried over and will be lost to the award (+/- 10%

rule will be applied). Therefore, it is important when developing the annual budget that applicants

plan carefully in order to enable draw-down of the full amount awarded.







and questionnaires



36

You are required to provide individual work package budgets and one overall budget summary.

Budgets will be set out in a modular fashion, and it is possible that the International Expert Panel will

recommend funding for some modules but not others.

A full detailed breakdown of costings and justification for all funding is required for items listed under

each subheading within GEMS.

In line with the allowable costs described in the guidance notes funding should be requested under the

following budget headings: Personnel costs, Running costs, FAIR Data management costs, Equipment

costs, Dissemination costs and Overhead costs.

Note: You are strongly advised to seek guidance from the research office/finance office in the host

institution before completing this section of the form. The HRB will not provide additional funding in the

case of either under-estimates or over expenditure.

Funds will be provided for the following:

1. Staff costs Must be listed for all salaried staff

a) Salary Gross Annual Salary (including 5% employee pension contribution)

negotiated and agreed with host institution. Applicants should use the

IUA website scales for the most up-to-date recommended salary scales

for academic researchers http://www.iua.ie/research-

innovation/researcher-salary-scales/

Please note employee pension contribution of 5% has already been

incorporated into the IUA gross salary figure.

Applicants are advised that public sector pay increases for the period

until end of 2020 have been agreed. Please find new pay scales at

https://www.iua.ie/research-innovation/researcher-salary-scales/ If

your application stretches beyond 2020; please apply a salary

contingency of 2.5% p.a.

Applicants should include annual pay increments for staff and related

costs (pension contribution, employer’s PRSI contribution, and

overhead contribution) in the budget.

Note: The HRB does not provide funding for the salary or benefits of

academic staff within research institutions that are already in receipt

http://www.iua.ie/research-innovation/researcher-salary-scales/


https://www.iua.ie/research-innovation/researcher-salary-scales/


37

of salary or benefits. The HRB does not provide salary or buy out time

for Partners/Collaborators.

b) Employer’s PRSI Employer’s PRSI contribution is calculated at 11.05% of gross salary.

c) Employer Pension

Contribution

Pension provision up to a maximum of 20% of gross salary will be paid

to the host institution to enable compliance with the Employment

Control Framework (an additional 5% employee contribution is part of

the salary). The level of employer contribution should be in

accordance with the model adopted by the host institution.

If applicable, state the amount of employer contribution based on the

pro rata salary and note the % of pro rata salary used to calculate this

for reference.

Exceptions apply where Circular letter 6/2007 applies. Circular Letter

6/2007 states that the pensions contribution of all Public Health

Service employees who, on or after 1 June 2007, are granted

secondments or periods of special leave with pay to enable them take

up appointments with other organisations, including other Public

Health Sector organisations, will be increased to 25% of gross

pensionable pay. The rate of 25% of gross pensionable pay referred to

in this context is the pension contributions to be paid by the body to

which the employee is seconded – it does not include any pension

contributions which employees make themselves. Where no such

arrangements are in place, the HRB will not be liable for costs.

2. Running Costs Contributions towards costs required to carry out the planned

activities including centralised data management, PPI costs and

training events. All costs must be fully justified.

The following costs are ineligible and will not be funded: inflationary

increases, cost of electronic journals.

Note: Please see a list of costs that fall within the overhead

contribution below and which should not be listed under running

costs.

4. FAIR data management

costs

Costs related to planning in relation to data management,

FAIRification, storage and archiving of research data in line with best

practice of data management and stewardship and the FAIR principles


38

as applicable to the portfolio of studies. Cost of data management

support calculated by hourly rates should also be included here. Data

Steward consultancy to support Network activities may be included.

Please consult Appendix III of the Guidance Notes for examples of

eligible costs.

5. Equipment Funding for small items of suitably justified equipment can be included

in this section. Personal/Stand-alone computers will not be funded as

these are considered a standard piece of office equipment, i.e.

overhead. All costs must be inclusive of VAT, where applicable.

We do not expect costs in excess of €20,000 for this call.

6. Dissemination Costs Costs associated with publication of results, seminar/conference

attendance (provide details of name and location, where possible) and

any other means of communicating/reporting research outcomes as

detailed under knowledge dissemination and exchange activities in the

dissemination and knowledge translation plan as well as costs related

to data sharing. Please refer to the HRB policy on Open Access to

Published Research21. Please list dissemination costs under the

following categories: publications, conferences, other activities

(expanded as necessary.)

7. Overhead Contribution In accordance with the HRB Policy on Overhead Usage, the HRB will

contribute to the indirect costs of the research through an overhead

payment of 30% of Total Direct Modified Costs (TDMC excludes

student fees, equipment and capital building costs) for laboratory or

clinically based research and 25% of Total Direct Modified Costs if

desk based research.

The following items are included in the overhead contribution:

recruitment costs, bench fees, office space, software, contribution to

gases, bacteriological media preparation fees, waste fees,

bioinformatics access.

6.1 Budget broken down by work packages In addition to the budget laid out above you are required to provide individual work package budgets

and one overall summary (including co-investment). these budgets will be considered by the

International Expert Panel during the review process and are necessary in the event that funding is

21 http://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-open-access//


39

recommended for some modules but not others. Please complete the template provided outlining the

cost categories associated with each work package and the overall budget summary for your Network.

Please add new sheets for further work packages. The Excel template can be downloaded from GEMS.

Please upload the completed Excel budget using the available upload function. This is a mandatory

upload.

6.2 HRB requested Budget Justification

(i) Please give a clear justification for each position requested, including FTE requirements, salary levels

etc. Please set out the proposed role in each case including which Work Packages this role relates to.

These HRB funded positions should be clearly identified within the requested Organogram in section 3.3.

(ii) Please give a clear justification for all other line items included in the budget.

(iii) Please describe how the budget requested from the HRB, plus additional co-investment, are

sufficient to successfully deliver the Work Packages. Please explain how good use is made of the budget

requested, sharing resources where it is appropriate. The word limit is 400 words.

6.3 Co-Investment Budget Commitment

A matched investment ratio of 2:1 (HRB: Cluster Partners) is expected i.e. for every €2 HRB investment

a minimum co-investment of €1 from academic partner, hospital group, individual hospital and or

other partners is required for the duration of the award.

Please summarise details on the co-investment commitment from Cluster Partners (including the HI) for

the duration of the proposed investment 2022-2026 under the usual budget categories; salaries, running

costs etc.

The total value of the co-investment contribution listed here should also be included in the full budget

section of the form under the co-investment contribution section.

Co-investment is required in the form of support for core staff and/or in kind contributions towards the

operation of the Clusters which will need to be verifiable under accounting standards. If in kind,

evidence is required of appropriate backfill arrangements (where applicable).

A Co-Investment Commitment Letter must be uploaded for each Cluster Partner (including the HI). This

letter should confirm that the funding contribution is in place. Electronic signatures are preferable

however typed signatures are acceptable for letters that are uploaded on the HRB GEMS system at this

time.


40

Please note that a copy of Collaboration Agreements between the HI and each Cluster Partner will be

requested by the HRB following contracting of the successful award.


6.3.1 Letters of Support (mandatory upload)

Formal Letters of Support from the Host Institution, hospital group, individual hospital and other

partners (if applicable) must be provided on headed notepaper and signed by the appropriate senior

manager (e.g. VP or Dean of the Research in university; CEO or equivalent in Hospital, Hospital Group,

associated charity or Foundation). Each Letter of Support must detail the supports provided to date by

that organisation, and to be provided during the term, as well as the income to be counted as co-

investment. More than one letter may be submitted.

Each letter should provide a narrative description of these supports (e.g. financial management,

Technology transfers supports, HR, access to space, cleaning and maintenance).

Further, each Letter of Support must include a budget table,

• detailing proposed co-investment for the duration of the award 1 Jan 2022 – 31 Dec 2026 (staff

and running costs only).

Please clarify that staff costs and running costs are specific to the work of the Cluster.

A template budget can be downloaded from GEMs (and is shown below).

Sufficient detail must be provided in the budget tables to allow direct comparison of requested HRB

budget and the level of financial support to be provided by the co-investment partners. This co-

investment will need to be verifiable under account standards by the HRB Finance team.

Electronic signatures are acceptable for letters that are uploaded on the HRB GEMS system. It is the

responsibility of the Lead Applicants to ensure that applications are completed in full and all necessary

documentation is received by the HRB on, or before, the closing dates indicated.

Budget Table A format: co-investment planned for period 1 Jan 2022-31 Dec 2026

Positions Cluster

Site

location

FTE €

2022

€

2023

€

2024

€

2025

€

2026

Cluster Salary

costs

supported

(includes


41

Employers

PRSI and

pension

contributions)

Position

(name)

FTE

Person A

(name)

1.0

Running costs

Running

cost A

Running

cost B

Total Direct

Salary and

running costs

Overhead

calculation

(30%)

Total costs

supported,

including o/h

calculation

7 Cluster Team

7.1 Cancer Clinical Lead Applicant’s Details

Details are requested about the Cancer Clinical Lead Applicant including their position and status

(contract or permanent), and their experience.

For Lead Applicants holding contract positions, a Letter of Support from the Head of School/Research

Centre must also be included.

The Lead Applicant’s contact and CV details (Name, contact information, institution, present position,

employment history, profession and membership of professional bodies) are managed in ‘manage my

details’ section of GEMS and are automatically included in any application created involving that

individual.


42

7.1.1 Publications and Funding Record

You are asked to include your 5 most relevant publications to this application on which you have acted

as senior author.

Publications are automatically included in any application created involving the Lead Applicant

Researcher. To update this information, edit the 'Update CV' section of 'Manage my Details' on GEMS.

You can then use the Publication selection tool in the relevant section of the application form to select

your 5 most relevant publications for this application.

You should also include your 5 most relevant funding awards as Principal Investigator or Co-Applicant.

For the purpose of this application form Funding Record details should be added directly on to the

application form and will not be pulled through from the ‘manage my details’ section of GEMS.

7.1.2 Evidence of Relevant Leadership Experience

The Cancer Clinical Lead Applicant is asked to describe any evidence of expertise or experience that they

have in leading consortia of different stakeholders and perspectives, this does not need to be a research

consortium. The word limit for this is 300 words.

7.1.3 Previous Experience in delivery of cancer clinical trials

The Cancer Clinical Lead Applicant is asked to provide any evidence or expertise they may have in

previous or current roles in the area of cancer clinical trials and to explain why this makes them a strong

candidate for the Cancer Clinical Lead Applicant role. This could include previous experience of working

in collaboration to design and deliver cancer clinical trials, to improve the quality of cancer clinical trials

or to promote the conduct of cancer clinical trials at a local and national level. The word limit for this is

500 words.

7.2 CRF Director Co-Lead Applicant Details

The CRF Director Co-Lead can manage their contact and CV details (Name, contact information,

institution, present position, employment history, profession and membership details of professional

bodies) under ‘Manage my Details’ section of GEMS and this information will be automatically included

in any application that involves this individual.

7.2.1 Evidence of experience and expertise relevant to this application

The CRF Director Co-Lead Applicant is asked to outline evidence or expertise relevant to this application

This could include previous experience of working in collaboration to deliver a portfolio of clinical

research or management of an infrastructure providing services and supports for clinical research. The

word limit for this is 500 words.


43

7.3 Site lead Co-Applicants

The site lead Co-Applicants can manage their contact and CV details (Name, contact information,

institution, present position, employment history, profession and membership details of professional

bodies) under ‘Manage my Details’ section of GEMS and this information will be automatically included

in any application that involves this individual.

The site lead Co-Applicant will be asked to provide additional information including their 5 most

relevant publications and their relevant funding record and their current position and status (contract

or permanent) will be requested in the application form.



as senior author.



7.3.2 Evidence of Relevant Management Experience

The site lead Co-Applicant is asked to describe any evidence of expertise or experience that they have in

leading teams to deliver work plans and deliverables, this does not need to be a research consortium.

The word limit for this is 300 words.


The site lead Co-Applicant is asked to provide any evidence or expertise they may have in previous or

current roles in the area of cancer clinical trials. This could include the successful delivery of clinical trials

and the management of personnel and services to achieve this. The word limit for this is 500 words.

7.4 Collaborators

A maximum of 10 collaborators can be added to the application.

The information for Collaborators is not automatically drawn from the ‘Manage my Details’ section of

GEMS but must be entered by the Network Lead Applicant. Details for all Collaborators should be

provided including name, contact information, institution or organisation, present position or type of

organisation. If relevant and applicable they may also include employment history, profession and

membership details of professional bodies, Publications (maximum 5) and Funding Record and details of

any past or current grants held (including HRB grants) relevant to this application where the partner has

acted as Principal Investigator or Co-Applicant.


44

For each collaborator please also outline their role in the Cluster. The word limit for this is 100 words.

Collaboration agreement forms (mandatory upload)

In addition, for each Collaborator a signed Collaboration Agreement Form must be provided. A

template Collaboration Agreement Form is available for downloaded from GEMS. Forms must be

completed, signed, dated and uploaded where indicated on HRB GEMS. Please label each form with the

name of the relevant Collaborator. Electronic or typed signatures are acceptable on letters/forms that

are uploaded on GEMS in this instance.

7.5 Staff

Please upload a word document containing a table with details of staff (both current and future)

required for delivery of the business plan. Specify the staff type, state the time each person will spend

on the grant, either as a percentage or proportion of a full time equivalent (FTE), indicate which work

packages(s) they will be involved in, describe their role in the proposed Cluster over the lifetime of the

award. If known you are asked to provide their name. Note - At least 0.5 FTE Programme Manager must

be provided for the duration of the award (funded by HRB or in-kind).

The table will provide an overview to the review panel of the team members and their contribution to

the Cluster.

A template word document can be downloaded here, an example is shown below in Figure 2.

Staff Type Name Work package (deliverable)

FTE Institution (affiliation- HSE or HI)

Funding sources

Employment Type Perm/ Contract/Temp

Director Jane Smith 1.3 1.0 UCD/HSE HRB/HI Perm

Associate director John Brown 2.4 0.5 TCD HI Perm

Director of Nursing Jane Smith 3.2 1.0 HSE HRB Perm

Senior Research nurse

John Brown

1.2

0.5

RSCI/HSE

HSE

Contract

Research nurse Jane Smith

5.2 1.0 UL/HSE HI Perm

Programme Manager

John Brown

1.4

1.0

HI

Perm

Research manager

Jane Smith

2.2

1.0

EU

Temp

Research assistant John Brown 3.1 1.0 HRB/HSE Perm

Etc.

Figure.2. Personnel requirements


45

7.5.1 Justification for Staff

Please give details of all staff to be funded in each partner site of the cluster if relevant. Note that you

must justify the nature of all staff relative to the scale and structure of the cluster. If funding is

requested for known staff, please include the following details: Name, address, present position,

academic qualifications and professional qualifications. It is expected that the award will predominantly

offer salary support for core staff members within the cancer delivery units, for example a Programme

manager (Cluster manager), clinical trial nurses and data managers. The word limit is 400 words.

7.6 Clinical Lead Applicant Role

Outline the role of the Clinical Lead Applicant in the Cluster on a day-to-day basis including the amount

of time to be dedicated to working on this project, either as a percentage or a proportion of a full time

equivalent (FTE). The word limit is 250 words.

7.7 CRF Co-Lead Applicant Role

Outline the role of the CRF Co-Lead Applicant in the Cluster on a day-to-day basis including the amount

of time to be dedicated to working on this project, either as a percentage or a proportion of a full time


7.8 Site Lead’s Role

Outline the role of each Site Lead in the Cluster on a day-to-day basis including the amount of time to be

dedicated to working on this project, either as a percentage or a proportion of a full time equivalent

(FTE).The word limit is 250 words.

8 Additional upload

You may include one further attachment to support your proposal. A maximum of 5 figures, which can

be a combination of images, graphs, tables, as appropriate may be uploaded as a single document,

which will appear in the Appendix. Figures must not be embedded within the text. The maximum size is

2MB (.doc .docx .pdf).

It is the responsibility of the Co-Lead Applicants to upload all supporting documentation to GEMS prior

to submission. If the documentation is not received by the HRB on time, in the correct format or is not

properly signed or submitted, the application may be deemed ineligible without further review.

The HRB reserves the right to reject any application that does not meet the terms of this call.

The HRB’s procedure for appealing funding decisions is available at http://www.hrb.ie/research-

strategy-funding/policies-guidelines-and-grant-conditions/policies-and-position-statements/

http://www.hrb.ie/research-strategy-funding/policies-guidelines-and-grant-conditions/policies-and-position-statements/

http://www.hrb.ie/research-strategy-funding/policies-guidelines-and-grant-conditions/policies-and-position-statements/


46


47

Appendix II: Detailed Guidance on the National Cancer Clinical Trials Network

Application Form

Only registered users of the GEMS system can apply for grants. In order to submit an online application

to the HRB, applicants are required to register at the following address:

https://grants.hrb.ie

Please refer to the GEMS Technical Guidance Note for further information.

Applications must be submitted on behalf of a team which is made up of a Network Lead (Clinical Lead)

and Co-Applicants and submitted through an approved HRB Host Institution.

The Network Lead (Clinical Lead) Applicant must create the application, but it can then be jointly

completed with the Co-Applicants

• Applications will be submitted on behalf of a team; lead by the Network Lead Applicant.

• The Network Lead Applicant must take on the role of submission to GEMs; their CV and

contact details will be pulled through from GEMs.

• The Co- Applicants must enter their details manually. The Co-Applicants must review and

approve the application prior to submission.

• Applicants can register on GEMS and they will receive an email to confirm their registration

and log in details. The Network Lead Applicant can then add information on their contact

and CV details in ‘Manage My Details’ section of GEMS.

• Applicants previously registered on GEMS can login to GEMS and update any information

regarding their contact and CV details in ‘Manage my details’.



Once the Clinical Lead Applicant selects the ‘Cancer Trials in Ireland- Network Application’ scheme on

GEMS, s/he will be asked to confirm their agreement to share personal data in the application.

The Clinical Lead Applicant will be then able to start the application.

Further details for completing each of the main sections of the application form are provided below:



48

1. Network Lead Applicant Declaration





2. Host Institution and Signatory Notification 2.1 Host Institution

The Host Institution (HI) for the HRB award is a HRB recognised host institution. This is normally that of

the Lead Applicant, but it may be another organisation/institution designated by the research team,

where it is clearly justified. An up to date list of HRB recognised host institutions can be found at all

times at: https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-

policy-on-approval-of-host-institutions/.

A list of the Host Institutions approved by the HRB at the time of this call going live is included as a PDF

on GEMS. In GEMS you will be asked to identify a Host Institution (from this list) and type it in full (do

not use acronyms such as UCD, TCD, NUIG). Once you have entered the first 3-4 characters of the HI,

you will be assisted with auto-select options.

Note: In order to be eligible to apply for funding, an Institution must have been approved as a HRB Host

Institution no later than two calendar months before the closing date of a call, only pre-approved HIs

will appear in this list.

2.2 Signatory Notification (within Host Institution)

Once the Host Institution is selected at the initial stages of application creation this will allow the Lead

Applicant to notify the authorised signatory (Dean of Research or equivalent person authorised to

endorse research grant applications for the Host Institution) in that Host Institution of the Lead

Applicant’s intention to submit an application to the Cancer Trials in Ireland Call. The signatory’s details

are pre-populated in the system so the applicant just needs to click ‘NOTIFY’ within GEMS. We

recommend that you notify the HI signatory of your intention to apply as soon as possible in the

application process. The signatory will receive an email from GEMS with the name and email details of

the Lead Applicant and if they have any queries or clarifications they can engage directly to resolve them

with the Lead Applicant. The HI signatory must confirm their willingness to participate as HI for the

application through GEMS and once they do this a PDF of the application will be available for them to

review with a view to them ultimately approving the final version for submission to the HRB.




49

3. Network Applicant Group

3.1 Network Lead Applicant’s Details

Details are requested about the Network (Clinical Lead) Lead Applicant including their position and

status (contract or permanent), and their experience.

For Lead Applicants holding contract positions, a Letter of Support from the Head of School/Research

Centre must also be included.

The Lead Applicant’s contact and CV details (Name, contact information, institution, present position,

employment history, profession and membership of professional bodies) are managed in ‘manage my

details’ section of GEMS and are automatically included in any application created involving that

individual.



as senior author.



You can then use the Publication selection tool in the relevant section of the application form to select

your 5 most relevant publications for this application.

You should also include your 5 most relevant funding awards as Principal Investigator or Co-Applicant.

For the purpose of this application form Funding Record details should be added directly on to the

application form and will not be pulled through from the ‘manage my details’ section of GEMS.

3.1.2 Evidence of Relevant Leadership Experience

The Network Lead Applicant is asked to describe any evidence of expertise or experience that they have

in leading consortia of different stakeholders and perspectives, particularly research consortia. The word

limit for this is 300 words.


The Network Lead Applicant is asked to provide any evidence or expertise they may have in previous or

current roles in the area of cancer clinical trials and to explain why this makes them a strong candidate

for the Network Lead Applicant role. This could include previous experience of working in collaboration


50

to design and deliver cancer clinical trials, to improve the quality of cancer clinical trials or to promote

the conduct of cancer clinical trials at a local and national level. The word limit for this is 500 words.

3.1.4 Letters of Support for Lead Applications seeking contributions to salary

For Network Lead applicants who are seeking a contribution to their own salary (buy out time to enable

time to Lead the Network); a Letter of Support from the Host Institution (and their HI if different from

the award HI) and hospital where they hold their clinical position must also be included.

The formal letter on headed notepaper, dated and signed by the Head of School/Research Centre and

the appropriate signatory within their hospital, must include the following information; [Host Institution

– Hospital name] which is the host institution/hospital employer of [applicant - insert name] confirms

that [applicant - insert name]: holds an employment contract which extends until [insert date] or will be

recognized by the host institution upon receipt of the Cancer trials in Ireland award as a contract

researcher; Electronic signatures are preferable however or typed signatures are acceptable for letters

that are uploaded on the HRB GEMS system at this time.

3.2 Co-Applicants Details

A maximum of 10 Co-Applicants can be added.

The Co-Applicants can manage their contact and CV details (Name, contact information, institution,

present position, employment history, profession and membership details of professional bodies) under

‘Manage my Details’ section of GEMS and this information will be automatically included in any

application that involves this individual.

The Co-Applicants will be asked to provide additional information including their 5 most relevant

publications and their relevant funding record and their current position and status (contract or

permanent) will be requested in the application form.



as senior author.




The Co-Applicant is asked to provide any evidence or expertise they may have in previous or current

roles in the area of cancer clinical trials relating to supporting collaborative clinical trials, network


51

membership, commercialisation, and effect on healthcare practise and/or policy. The word limit for this

is 500 words.

3.2.3 Co- Applicant Role

Outline the role of the Co- Applicants in the Network on a day-to-day basis, including the amount of

time to be dedicated to working on this grant, either as a percentage or a proportion of a full time


3.3 Collaborator Details

A maximum of 10 collaborators can be added.

The information for Collaborators is not automatically drawn from the ‘Manage my Details’ section of

GEMS but must be entered by the Network Lead Applicant. Details for all Collaborators should be

provided including name, contact information, institution or organisation, present position or type of

organisation. If relevant and applicable they may also include employment history, profession and

membership details of professional bodies, Publications (maximum 5) and Funding Record and details of

any past or current grants held (including HRB grants) relevant to this application where the partner has

acted as Principal Investigator or Co-Applicant.

In addition, for each Collaborator a signed Collaborator Agreement Form must be provided. A template

Collaborator Agreement Form is available for downloaded from GEMS. Forms must be completed,

signed, dated and uploaded where indicated on HRB GEMS. Please label each form with the name of the

relevant Collaborator. Electronic or typed signatures are acceptable on letters/forms that are uploaded

on GEMS in this instance.

Collaborator Agreement form (mandatory upload)

Please upload a signed Collaborator Agreement Form for all named Collaborators in this section.

Collaborator Role

Outline the role of the Collaborators role in the Network on a day-to-day basis, including the amount of

time to be dedicated to working on this grant, either as a percentage or a proportion of a full time


3.4 Network Lead Applicant Role


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Please indicate the current commitment to research/clinical/teaching/other, either as a percentage or a

proportion of a full time equivalent (FTE). Outline the role of the Clinical Lead Applicant in the Network

on a day-to-day basis including amount of time to be spent working on the network either as a

percentage or proportion of a full time equivalent (FTE).


3.5 Network Clinical Lead Profession and Occupational Speciality Environment

Please state the Clinical Leads’ profession and occupational speciality, the approximate number of

individuals trained in this speciality in Ireland and approximately how many of these are engaged in

research and where are the main centres/sites that this research is currently being undertaken? The word

limit is 200 words.

3.6 Staff

Please upload a word document containing a table with details of staff (both current and future) required

for delivery of the business plan. Specify the staff type, state the time each person will spend on the

grant, either as a percentage or proportion of a full time equivalent (FTE), indicate which work packages(s)

they will be involved in, describe their role in the proposed National Cancer Clinical Trial Network over

the lifetime of the award. If known you are asked to provide their name. Note - At least 0.5 FTE Programme

Manager must be provided for the duration of the award (funded by HRB or in-kind).

A template word document can be downloaded here.

The table will provide an overview to the review panel of the Network applicant team members and

their contribution to the national network.

Staff Type Name Work package (deliverable)

FTE Institution (affiliation- HSE or HI)

Funding sources

Employment Type Perm/ Contract/Temp

Director Jane Smith 1.3 1.0 UCD/HSE HRB/HI Perm

Associate director

John Brown 2.4 0.5 TCD HI Perm

Director of Nursing

Jane Smith 3.2 1.0 HSE HRB Perm

Senior Research nurse

John Brown

1.2

0.5

RSCI/HSE

HSE

Contract

Research nurse

Jane Smith

5.2 1.0 UL/HSE HI Perm

Programme Manager

John Brown

1.4

1.0

HI

Perm


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Research manager

Jane Smith

2.2

1.0

EU

Temp

Research assistant

John Brown 3.1 1.0 HRB/HSE Perm

Etc.

3.6.1 Justification for Staff

Please give details of all staff to be funded in the Network. Note that you must justify the nature of all

staff relative to the activity of the Network. If funding is requested for known staff, please include the

following details: Name, address, present position, academic qualifications and professional

qualifications. It is expected that the award will predominantly offer salary support for core staff

members within the Network including, but not limited to clinical research nurses and data managers.


3.7 Strength and Complementarity of the Network Applicant Group

Please describe how the formation of this network applicant group strengthens this proposal in terms of

complementarity of scientific expertise, synergistic potential and the added value of the collaboration.

Show how the team has the collective expertise, competencies and experience to successfully deliver

this network, under the leadership of the Network Lead Applicant(s). Does the applicant group have

appropriate statistical, methodological and data management expertise to enable them to develop a

portfolio of suitably designed studies (if not then describe how this will be accessed in the next section

“infrastructure and support”). The word limit is 800 words.

4. Network Overview

4.1 Entity/Network name Please name your entity or network in the space provided.

4.2 Network Duration and Start date

Please indicate the expected start date. Please note that awards are 60 months in duration and all awards are expected to commence during January 2022. Please note that the earliest start date will be 01 January 2022.

4.3 Network Summary

Please provide a summary of the proposed activities of the Network and how they might contribute to

the provision of equitable access for all cancer patients to high quality cancer clinical trials across the

island of Ireland. Please also describe how this Network sits within the national context. The word limit

is 500 words.


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4.4 Lay Summary

Please provide a lay summary of the Network and its proposed activities. The lay summary needs to be

written as a plain English summary, such that it is a stand-alone document that is clear, easy to

understand, and is easily accessible to a broad lay audience. Avoid the use of highly technical terms. This

summary may be used when providing information to the public concerning the variety of research

funded by the HRB. The word limit is 300 words.

5. Network Description

Please ensure that your application is focused, and that sufficient evidence is provided to enable the

international selection panel to reach a considered judgement as to how the proposed Network meets

each of the assessment criteria.

In addition to this there are a number of expectations set out in the guidance notes for the Network.

Please ensure that you describe how this application will be used to meet the expectations of a national

network under the call for cancer trials in Ireland.

A National Cancer Clinical Trials Network will be expected to:

• Partner with an academic host institution

• Provide Governance support as Sponsor for the conduct of multicentre regulated cancer clinical

trials

• Provide Support services for studies including project management, database design and build,

clinical trial data management, data analysis, statistical analysis plans and reports, monitoring,

reporting and administration of trial activity at each approved cluster where required. They will

also be mandated to report on trial delivery and performance.

• Provide Networking support for Clusters to;

o Network and integrate at a national level the critical mass of expertise and resources

needed to provide Irish leadership in Investigator-led and commercial cancer clinical

trials

o Pro-actively establish and grow partnerships with Collaborative groups, Charities and

Industry, as appropriate to the portfolio of cancer trials

o Design and develop a portfolio of high-quality cancer clinical trials

o Ensure policies on the:

▪ study selection and prioritisation for the network as a whole

▪ peer review of clinical trials which do not come with external competitive

funding e.g. commercial trials

▪ procedure and criteria for stopping trials within the cancer portfolio that is

maintained and implemented

▪ management of contributions from industry collaborators including a charging

model/list of fees for commercial studies


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o Embed public and patient involvement in all cancer clinical trials

o Provide network support to all trial delivery teams at sites by providing a

communication platform for all members e.g. development of a community of practice.

5.1 Background to Network

This scheme will provide support for established entities with a previous track record of providing

services and supports for the conduct and delivery of high quality, safe and compliant cancer clinical

trials.

Describe the background to the cancer clinical trial network including what is already in place, setting this

clearly within a national context. Explain the rationale behind the establishment of a national cancer

clinical trials network and what it has achieved to date. Articulate the added value from this network and

what would this HRB award enable that would not happen otherwise?


A file upload option is available to include an attachment to support the background to network

provided. A maximum of 8 figures, which can be a combination of images, graphs, tables, scales,

instruments or surveys, may be uploaded as a single document on HRB GEMS. They must not be

embedded within the text of the background to network. The maximum size is 2MB.

5.2 Vision and Mission

Please state the vision and mission of the Network, that includes the period 2022 - 2026. The word limit

is 50 words

5.3 Strategic Direction

Briefly describe the strategic position of the Network. Detail key opportunities and strategic challenges

for the Network. Please describe the strategic objectives aligned with the vision and mission including

details of planned strategic alignment with the following:

- National Cancer Strategy 2017-202622,

- The proposed Cancer Clinical Trial Clusters

- CRF/Cs

- National clinical trials coordination programme

- regional integrated care organisations

- other collaborative groups, charities and industry as appropriate to the portfolio.

Describe the overarching research strategy of the national cancer clinical trial network; if not currently in

place outline how it is planned to establish one.

22 https://www.gov.ie/en/publication/a89819-national-cancer-strategy-2017-2026/

https://www.gov.ie/en/publication/a89819-national-cancer-strategy-2017-2026/


56

Give a high-level description of the cancer clinical trials portfolio (on-going and recently completed

studies (2017/18/19/20)23, demonstrating that the Network applicant team members have worked

together on cancer clinical trials.

Please outline planned studies for the term of the award (with proposed team members), which

demonstrates the scientific breadth and depth of the network.

For each proposed study, please indicate where funding has already been secured for planned studies, or

if it is intended to bid for competitive funding (stating the potential funding source including supports

claimed under Cluster applications). The word limit is 2000 words.

5.4 Network Infrastructure

Please describe the current levels of infrastructure present in the Network or the proposed level of

infrastructure, utilised to support cancer clinical trials. Include reference to specific personnel and their

roles and responsibilities.

If successful in this award what levels of infrastructure will be required for the successful delivery of the

proposed business plan? What reorganisation (if any) will be required to fulfil these requirements?


5.5 Management, Governance and Strategic Oversight

Provide a high-level description of the oversight, advisory or governance structures that are currently in

place or will be put in place for the Network. Please provide details about any reporting relationships

with the HI, Clusters, and external governing bodies as appropriate. Include details of Governance

Board, Scientific Advisory Boards and any other committees as applicable, including the scientific

advisory groups of the national cancer clinical trial network (please detail role/membership/frequency

of meetings). The word limit is 500 words.

The National Cancer Clinical Trials Network and Clusters are also expected to cooperate fully with any

HRB Clinical Trials Infrastructure Expert Advisory Group. This Expert Advisory Group is anticipated to

assist the HRB in the strategic oversight and performance monitoring of the Infrastructures, networks

and Interventions portfolio.

5.5.1 Organogram (mandatory upload) Please include an organisational chart/organogram to illustrate the Cluster structure, management and

governance using the file upload option on GEMS.

23 Details of individual studies performance in the specified four year period will be entered in a separate section numbered 5 below.


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5.6 Operational model

Describe the current or proposed operational model within the Network which supports a national

cancer clinical trial portfolio. Please describe how this operational model is appropriate to the stage and

scale of the Network’s activities.

With reference to the expectations of a Network detailed in the guidance document please outline in

detail how the operational model does/will fulfil expectations including:

• Provision of governance support for studies

• Provision of support services for studies

• Provision of networking support for clusters

Please describe under each of the above bullet points, the scope of supports that will be provided and

the exact process for access and provision of same.

Explain how the network currently scales resources according to demand for support. Describe

processes for making decisions on scientific direction and allocation of resources (e.g. selection of

studies).

Briefly describe key policies and processes. This should include but is not limited to study selection and

prioritisation, peer review of cancer clinical trials, procedures for stopping trials, study costing, resource

allocation and management of contributions from industry collaborators. You may embed links to key

SOPs/policies.

Please note the results of recent audit reports, if available.


A file upload option is available to include an attachment to support your operational model description.

A maximum of 8 figures, which can be a combination of images, graphs, tables, scales, instruments or

surveys, may be uploaded as a single document on HRB GEMS. They must not be embedded within the

text of the operational model description. The maximum size is 2MB.

5.7 Do you have a policy on the procedure and criteria for stopping trials?

If yes, please upload to GEMS using the available upload button.

5.8 Network integration with the Clusters

Summarise the planned network integration and activities with the Clusters. Explain how the network

leadership will manage growth and expansion of the network to engage a broader community of


58

researchers/clinicians. Specifically explain how new members will be incorporated during the lifetime of

the award and at what point will this happen.


5.8.1 Clinical Research Infrastructure Agreement Form (mandatory upload)

A Clinical Research Infrastructure Agreement Form must be completed for each Cluster and can be

downloaded from GEMS. The Form must be completed, signed, dated and uploaded on GEMS.

Electronic signatures are acceptable for letters/forms that are uploaded on GEMS.

5.9 Host Institution Support

Describe the infrastructure, facilities, specialist expertise and other support available at the Host

Institution for the Network. Summarise if any additional support or commitment is proposed by the

Host Institution or participating/collaborating institutions e.g. financial and/or other support. Please

include details of additional institutional supports in areas such as business development, legal,

marketing expertise where this is being provided above and beyond the activities/expertise of members

of the Network team.


5.10 Financial Management support for Network

Please provide details about the current financial management processes to manage Network income

and expenditure. Please include information on accounts to be used, processes such as invoicing, and

processes to enable income and expenditure to be reported on an annual basis. Please comment on the

appropriateness of the system and any planned changes.


5.11 Letters of Support (mandatory upload)

Applications will need to be coordinated at a national level. This may take the form of letters of support

from host institutions, hospital groups, CRF/Cs, Chairs of the Cancer Disease Specific Sub-Groups and

other relevant stakeholders.

6. Clinical Trial Performance to date

6.1 Registered clinical trials activity

Please list all registered cancer clinical trial activity at Cancer Trials Ireland from 1 Jan 2017 to 31 Dec 2020

from earliest to most recent, in the accompanying Metrics Excel spreadsheet template. A full explanation

of terms is given in the “Clinical Trial Data Definitions” document.

Please note that only registered trials can be captured in the spreadsheet. If there are multiple

registration numbers, please quote the ClinicalTrials.gov registration number.


59

Please upload the completed Excel spreadsheet to GEMS using the available upload function.

6.2 Cancer Clinical Trials: graphical analysis

As an overview of the current Network/organisation clinical trials portfolio please upload a single two-

page document comprising 4 graphs of trial data from 1 Jan 2017 to 31 Dec 2020 from the spreadsheet,

displaying:

e. All registered trials during period broken down by phase “Column H”

f. All registered trials during period broken down by disease area “Column L”

g. All registered trials during period broken down by Sponsor i.e. Industry v Academic v Cancer Trials Ireland sponsored (2017-2020)

h. # of trials opening at each site per year (2017-2020)

See attached example for format of graph to be used, for ease of comparability for the reviewers.

Please upload the graphs in word document/PDF format to GEMS using the available upload function.

6.3 Trial portfolio performance

Please detail the approach of the Network to the measurement of performance of individual trials and of

the portfolio overall.

Give details of those performance metrics in the period 1 Jan 2017 – 31 Dec 2020, such as but not limited

to start up speed24 and recruitment reliability25, and note improvements in same over time.

In addition, please provide the following details:

- Was planned recruitment achieved: globally?

- Was planned recruitment achieved: at the sites in Ireland?

- The tools and software packages used to aid performance monitoring

- the person(s) responsible for the collection and collation of such data

- changes in data collection process and procedures that the Network may use to improve the

collection and reporting of data


6.4 Other clinical research activity

Please describe the breadth of research in the Network and give an indication of the current level of

activity in cancer clinical trials, compared with other cancer clinical research studies.


24 Start up speed- median number of days from receipt of protocol to regulatory approval or ethical approval 25 Recruitment reliability – number of actual participants randomised as % of number planned per study


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6.5 Summary of recent achievements

Please give brief details (bullet points preferred) to give an idea of recent achievements in the network

and key areas of activity with a brief description of the role of Network staff in each case. Areas to cover

may include: key cancer clinical trials attracted to Ireland, healthcare innovations developed/tested,

clinical guidelines, policy and practice influences, education/capacity building, IP and commercial

developments. The word limit is 400 words.

7. Network Business Plan (2022-2026)

7.1 Proposed Business Plan

Summarise the overall business plan that will achieve the strategic objectives of the Network

highlighting how current studies will be managed and completed and how future studies will be

designed, developed, selected and supported throughout their lifetime. The word limit is 300 words.

7.1.1 Proposed Business Plan

Please add a number of work packages which map to the relevant strategic objectives and detail how

they will integrate to deliver a coherent portfolio of high quality cancer clinical trials and network the

cancer clinical trial community.

Each work package should include objectives, deliverables and milestones which will be finalised during

contract negotiations, as informed by the international review panel. Final deliverables will form part of

the contract should you be successful and will be used by the HRB for monitoring of the progress of the

award, in addition to agreed performance metrics.

The Network is expected to integrate with other HRB-funded clinical trial infrastructures nationally to

collectively improve patient access to clinical trials, integrate relevant best practices where necessary to

support national performance for the benefit of the Irish clinical trials system. These include the Cancer

Clinical Trial Clusters, Clinical Research Facility/Centres, National Clinical Trials Coordination Programme

and HRB Trials Methodology Research Network. Activity and resources should be assigned for that

purpose. Ideally this should be a distinct work package pertaining to coordination.

PPI should play a critical role in clinical trials. It is the role of the Network under this call to promote and

support the embedding of PPI into cancer clinical trials in Ireland. The promotion of high quality and

meaningful PPI in Network activities and cancer clinical trials in Ireland should be a distinct work

package for the Network. The work package should capture both the larger scale national promotion of

PPI and the day to day activities of providing support for researchers’ PPI activities both during the

development of an application and during the conduct of a trial.


61

Work Packages should be mapped against estimated completion timelines in a Gantt chart, and any

milestones highlighted. In addition, please detail the resources and personnel required for each work

package within the description of the work package All personnel included in the application budget

must be associated with a work package both in this section and in this section 3.8.


7.1.2 Gantt chart (mandatory upload)

You must upload a Gantt chart that lists the above Work Packages, tasks and deliverables against the

estimated timelines for completion, together with any additional milestones/key dates (example in

Figure 1).

Figure 2: Example of Gantt chart template available from the HRB.

Please upload the completed Gantt Chart using the available upload function.

7.2 Other Collaborations and Partnerships

Please provide a brief summary of plans for the development of collaborations and partnerships. Outline

any existing or planned collaboration, stating clearly if it as a local, regional, national or international

activity. The word limit is 1000 words.

7.3 Trial Registration and Reporting

Please outline the procedure for ensuring the timely registration and reporting of all clinical trials

sponsored by the network. Outline how this information will be recorded and who will be responsible

for this information. The word limit is 200 words.


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7.4 Equality, diversity and inclusion

Equality, Diversity and Inclusion should be considered throughout your Network proposal. Please identify

and explain how you address Equality, Diversity and/or Inclusion in the Network.


7.5 Potential Risks and Ethical Concerns

Please address any potential risk and/or harm to the safety of the patients or human

subjects/participants in the network, if relevant; and highlight any potential ethical concerns, even if not

part of this application, and how you propose to deal with them. The word limit is 300 words.

7.6 Communication Plans

Please provide a clear communications plan to indicate how you plan to identify and engage with your

stakeholders. Details may include for example:

• Stakeholder analysis

• Key communication messages

• Timing and mode of engagement

• Team member responsible for communications activities

Include a clear dissemination and knowledge exchange plan to indicate how the outputs you anticipate

producing during and after the National Cancer Clinical Trials Network will be disseminated, shared and

made openly accessible, in line with HRB Open Access Policy26. Outputs include peer-reviewed

publications, non-peer reviewed publications and conference proceedings, reports, policy briefings,

guidelines, training materials and so on. Protection of Intellectual Property should be considered before

data are disseminated27.


7.7 FAIR Data Management

The HRB Policy on Research Data Management governs data gathered and generated in whole or in part

from HRB-funded research from 1st of January 2020. While Research Data Management Plans will have

to be developed on a study-by-study basis, Network Lead Applicants should consider how studies within

the portfolio can ensure they are in line with policy requirements (of HRB and other funders). Please

describe how you will work with support of data stewards (within the network) or other data-related

services support in the Host Institution (typically library and ICT and digital services, etc) on approaches

to data management and stewardship for the Network.. Please consider the FAIR Guiding Principles for

26 http://www.hrb.ie/research-strategy-funding/policies-and-guidelines/policies/open-access/ 27 All HRB Host Institutions must subscribe to the National Intellectual Property Protocol, ‘Inspiring Partnership- the national IP Protocol 2016: Policies and resources to help industry make good use of public research in Ireland’, prepared by Government/Knowledge Transfer Ireland to ensure transparent and consistent procedures for managing Intellectual Property from publicly funded research.

http://www.hrb.ie/research-strategy-funding/policies-and-guidelines/policies/open-access/


63

scientific data management and stewardship: Findability, Accessibility, Interoperability, and

Reusability28. Please consider issues such as the types, volume and format of data, and what data will be

collected, processed or generated. Consider what metadata and documentation will accompany the

data. Will there be a globally resolvable, unique, persistent identifier (such as DOI)? What data quality

control measures will be used? Please consider how data will be stored and backed up. How will data

security be addressed? How and when will you share the data? How will you select data for preservation

and where data will be preserved long term (e.g. data repository, archive). What methods or software

tools will be required to access data? Who will be responsible for data management (e.g. data steward)

and the time needed for data management and for making data FAIR (costs may be added under the

budget section). The word limit is 500 words

7.8 Compliance with GDPR

Please comment on how your proposed Network complies with The General Data Protection Regulation

(EU) 2016/679, if relevant, especially where execution of study activity involves the transfer of data

outside of the EU. The word limit is 200 words.

8. Project Budget

8.1 Project Budget

Please provide a summary and justification of the costs and duration associated with the award.

Total HRB funding for the National Cancer Clinical Trial Network will be up to a maximum of €1,461,250

per annum over five years (inclusive of 25% overheads).

The award will predominantly offer support for operational costs such as, but not limited to salary for

• core staff in database design and build, clinical trial data management, data analysis, statistical

analysis, monitoring etc.

• administration support and project management support for the central function, and / or

• clinical lead buy-out time to strategically lead the Network (maximum salary contribution of

€100K per annum).






28 Wilkinson, M. D. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci. Data 2016 3:160018 doi: 10.1038/sdata.2016.18


64


and questionnaires


You are required to provide individual work package budgets and one overall budget summary.

Budgets will be set out in a modular fashion, and it is possible that the International Expert Panel will

recommend funding for some modules but not others.

A full detailed breakdown of costings and justification for all funding is required for items listed under

each subheading within GEMS.

Please

In line with the allowable costs described in the guidance notes funding should be requested under the

following budget headings: Personnel costs, Running costs, FAIR Data management costs, Equipment

costs, Dissemination costs and Overhead costs.

Note: You are strongly advised to seek guidance from the research office/finance office in the host

institution before completing this section of the form. The HRB will not provide additional funding in the

case of either under-estimates or over expenditure.

Funds will be provided for the following:

1. Personnel costs Must be listed for all salaried personnel under each of the following

subheadings (a-c):

Contributions to Personnel costs: as appropriate and justified given

the scale and scope of Network activities (e.g. Trial design expertise,

Data Analysis, Statistical Analysis, clinical trial monitoring).

a) Salary Gross Annual Salary (including 5% employee pension contribution)

negotiated and agreed with host institution. Applicants should use the

IUA website scales for the most up-to-date recommended salary scales

for academic researchers http://www.iua.ie/research-

innovation/researcher-salary-scales/

Please note employee pension contribution of 5% has already been

incorporated into the IUA gross salary figure.

Applicants are advised that public sector pay increases for the period

until end of 2020 have been agreed. Please find new pay scales at

https://www.iua.ie/research-innovation/researcher-salary-scales/ If



https://www.iua.ie/research-innovation/researcher-salary-scales/


65

your application stretches beyond 2020; please apply a salary

contingency of 2.5% p.a.

Applicants should include annual pay increments for staff and related

costs (pension contribution, employer’s PRSI contribution, and

overhead contribution) in the budget.

b) Employer’s PRSI Employer’s PRSI contribution is calculated at 11.05% of gross salary.

c) Employer Pension

Contribution

Pension provision up to a maximum of 20% of gross salary will be paid

to the host institution to enable compliance with the Employment

Control Framework (an additional 5% employee contribution is part of

the salary). The level of employer contribution should be in

accordance with the model adopted by the host institution.

If applicable, state the amount of employer contribution based on the

pro rata salary and note the % of pro rata salary used to calculate this

for reference.

Circular Letter 6/2007 states that the pensions contribution of all

Public Health Service employees who, on or after 1 June 2007, are

granted secondments or periods of special leave with pay to enable

them take up appointments with other organisations, including other

Public Health Sector organisations, will be increased to 25% of gross

pensionable pay. The rate of 25% of gross pensionable pay referred to

in this context is the pension contributions to be paid by the body to

which the employee is seconded – it does not include any pension

contributions which employees make themselves. Where no such

arrangements are in place, the HRB will not be liable for costs. If

requesting pension costs linked to Circular 6/2007, please provide

details as justification for the request.

2. Running Costs Eligible running costs include but are not limited to a communication platform for all members, travel, meeting costs and networking events. All costs must be fully justified. Costs associated with involving members of the public or patients in in

PPI activities e.g. consultation workshops, costs of participation in

advisory groups, travel expenses, honoraria, etc. should be charged to

running costs.


66

The following costs are ineligible and will not be funded: inflationary increases, cost of electronic journals. Note: Please see a list of costs that fall within the overhead

contribution below and which should not be listed under running

costs.

4. FAIR data management

costs

Costs related to planning in relation to data management,

FAIRification, storage and archiving of research data in line with best

practice of data management and stewardship and the FAIR principles

as applicable to the portfolio of studies. Cost of data management

support calculated by hourly rates should also be included here. Data

Steward consultancy to support Network activities may be included.

Please consult Appendix III of the Guidance Notes for examples of

eligible costs.

5. Equipment Funding for small items of suitably justified equipment can be included

in this section. Personal/Stand-alone computers will not be funded as

these are considered a standard piece of office equipment, i.e.

overhead. All costs must be inclusive of VAT, where applicable.

We do not expect costs in excess of €20,000 for this call.

6. Dissemination Costs Costs associated with publication of results, seminar/conference

attendance (provide details of name and location, where possible) and

any other means of communicating/reporting research outcomes as

detailed under knowledge dissemination and exchange activities in the

dissemination and knowledge translation plan as well as costs related

to data sharing. Please refer to the HRB policy on Open Access to

Published Research29. Please list dissemination costs under the

following categories: publications, conferences, other activities

(expanded as necessary.)

29 http://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-open-access//


67

7. Overhead Contribution In accordance with the HRB Policy on Overhead Usage, the HRB will

contribute to the indirect costs of the research through an overhead

payment of 30% of Total Direct Modified Costs (TDMC excludes

student fees, equipment and capital building costs) for laboratory or

clinically based research and 25% of Total Direct Modified Costs if

desk based research.

The following items are included in the overhead contribution:

recruitment costs, bench fees, office space, software, contribution to

gases, bacteriological media preparation fees, waste fees,

bioinformatics access.

8.2 Budget broken down by work packages In addition to the budget laid out above you are required to provide individual work package budgets

and one overall summary (including co-investment). these budgets will be considered by the

International Expert Panel during the review process and are necessary in the event that funding is

recommended for some modules but not others. Please complete the template provided outlining the

cost categories associated with each work package and the overall budget summary for your Network.

Please add new sheets for further work packages. The Excel template can be downloaded from GEMS.

Please upload the completed Excel budget using the available upload function. This is a mandatory

upload.

8.3 HRB requested Budget Justification

(i) Please give a clear justification for each position requested, including FTE requirements, salary levels

etc. Please set out the proposed role in each case. These HRB funded positions should be clearly identified

within the requested Organogram in section 5.5.

(ii) Please give a clear justification for all other line items included in the budget.

(iii) Please describe how the budget requested from the HRB, including co-funding or leveraged supports

are sufficient to successfully deliver the Work Packages. Please explain how good use is made of the

budget requested, sharing resources where it is appropriate. The word limit is 400 words.


68

Appendix III: FAIR Data Management

Introduction

For researchers, the move to FAIR and open30 data, where possible, means that they have the

responsibility to think about what data their research will produce, how these data will be described, and

how they can be made available in such a way so as to benefit science and society in general. This means

that they have to draw up a data management plan (in collaboration with professionally trained

colleagues) and find suitable data repositories at a very early stage of their research. FAIR principles should

be applied to all research involving data and/or software creation and so be included in all data

management plans (DMPs). The DMP is not be a goal in itself and should not be regarded as an additional

administrative hurdle. It should instead provide an opportunity at an early stage of the research project

to consider how the data generated within a project will be stored, managed and safeguarded, and thus

be part of the research process from the outset. As a project progresses, the data generated may well

change in type and volume, so the DMP should be seen as a dynamic framework which should be

maintained and modified as the research advances.

DMP Requirements

The HRB’s policy on management and sharing of research data31 came into effect on 1st January 2020. In

line with this policy, all successful applicants will be required to submit a completed data management

plan (DMP) to the HRB at the beginning of the study and a final updated version of the DMP with the

final report at the end of the study. The DMP will need to be submitted alongside a certification of

approval from the designated representative(s) within the Host Institution. Successful applicants will be

expected to use the HRB Data Management Plan template available through DMPOnline -

https://dmponline.dcc.ac.uk/

The requirements of the HRB’s DMP template can be found here

https://dmponline.dcc.ac.uk/template_export/1814665590.pdf

30 Please note that not all FAIR data are necessarily open. Where data raises data protection or security concerns, controls and limits on data access will be required. In some cases, it will be appropriate for researchers to delay or limit access to data in order to secure intellectual property protection. Any such restrictions on access should be justified, made explicit via machine-actionable licensing and built-in accessibility protocols mechanisms. 31 https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-management-and-sharing-of-research-data/

https://dmponline.dcc.ac.uk/

https://dmponline.dcc.ac.uk/template_export/1814665590.pdf

https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-management-and-sharing-of-research-data/

https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-management-and-sharing-of-research-data/


69

FAIR Data Management Costs

Examples of FAIR Data Management Costs are listed in the table below. Costs related to management,

FAIRification, storage and archiving of research data (as part of the DMP pilot the HRB is currently

conducting) in line with best practice of data management and stewardship and the FAIR principles. Some

of the eligible costs may include:

People Staff time per hour for data collection, data anonymisation,

staff time per hour for data management/stewardship support, training, etc

Storage and

computation cloud storage, domain hosting charge

Data access secondary data access, costs for preparing data for sharing (eg anonymisation)

Deposition and reuse

costs for depositing research data and metadata in an open access data

repository

e.g. defining semantic models, making data linkable, choosing the licence,

defining metadata for dataset, deploying/publishing

Others Please further explain

Please note this list is not exhaustive and aims to provide examples only of eligible costs. Please note the

HRB is currently not covering the cost of long-term preservation of data.

Who can help?

Support for developing Data Management Plans may be available at Host Institution level from the

following people:

Jacintha Maron, Cancer Trials Ireland

Aoife Geraghty, University of Limerick

Caleb Derven, University of Limerick

Aishling Hayes, University of Limerick

Trish Finnan, National University of Ireland Galway

Peter Corrigan, National University of Ireland Galway

Stephen Madden, Royal College of Surgeon Ireland

Andrew Simpson, Royal College of Surgeon Ireland

Brendan Palmer, University College Cork

Eoghan O'Carraghin, University College Cork

Aoife Coffey, University College Cork

Darren Dahly, University College Cork

Niamh Brennan, Trinity College Dublin

Darach Golden, Trinity College Dublin

John Donovan, Technological University Dublin

Yvonne Desmond, Technological University Dublin


70

Fran Callaghan, Dublin City University

Paul Skelton, University College Dublin

Jenny O'Neill, University College Dublin

Therese Ahern, Cork Institute of Technology

Fiona Morley, Maynooth University


71

Appendix IV: References/Useful Links

Study design for interventions

• “Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials:

Development of a Conceptual Framework” by Eldridge S. et al.

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150205

• “The PRECIS-2 tool: designing trials that are fit for purpose” by Louden et al.

http://dx.doi.org/10.1136/bmj.h2147

• “A process for Decision-making after Pilot and feasibility Trials (ADePT): development

following a feasibility study of a complex intervention for pelvic organ prolapse” by Bugge

C et al.

http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-353

• “Developing and Evaluating Complex Interventions” by MRC, UK

www.mrc.ac.uk/complexinterventionsguidance

• “Process evaluation of complex interventions: Medical Research Council guidance” by

Moore GF. et al.


• “Using natural experiments to evaluate population health interventions: Guidance for

producers and users of research evidence” by MRC, UK

www.mrc.ac.uk/naturalexperimentsguidance

• COMET (Core Outcome Measures in Effectiveness Trials) Initiative: development and

application of agreed standardised sets of outcomes, known as ‘core outcome sets’

http://www.comet-initiative.org/

Study registration

• International Clinical Trials Registration Platform (run by the WHO)

http://apps.who.int/trialsearch/Default.aspx

• European Clinical Trials Database (EudraCT): database of all regulated clinical trials which

commenced in the EU from 1 May 2004

https://eudract.ema.europa.eu/results-web/

• US National Library of Medicine database: database of privately and publicly funded clinical

studies – regulated and unregulated - conducted around the world

https://www.clinicaltrials.gov/

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150205


http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-353

http://www.mrc.ac.uk/complexinterventionsguidance


http://www.mrc.ac.uk/naturalexperimentsguidance

http://www.comet-initiative.org/

http://apps.who.int/trialsearch/Default.aspx

https://eudract.ema.europa.eu/results-web/

https://www.clinicaltrials.gov/


72

Reporting

• Consort 2010 Statement: updated guidelines for reporting parallel group randomised trials

www.consort-statement.org

• EQUATOR Network Library for health research reporting: an international initiative that

seeks to improve reliability and value of health research literature by promoting transparent

and accurate reporting of research studies

https://www.equator-network.org/library/

• Registry of Research Data Repositories

http://www.re3data.org/

• Zenodo Data Repository (OpenAIR)

https://zenodo.org/about

Public and Patient Involvement

• Public Involvement Impact Assessment Framework: Provides tools for successful

involvement of members of the public in research projects and for assessment of impacts

http://piiaf.org.uk/

• PPI cost calculator

http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-

involvement/involvement-cost-calculator/

• European Patient Forum Value + Handbook: For Project Co-ordinators, Leaders and

Promoters On Meaningful Patient Involvement

http://www.eu-patient.eu/globalassets/projects/valueplus/doc_epf_handbook.pdf

• The James Lind Alliance Priority Setting Partnerships: Research priorities in disease areas set

jointly by patients, clinicians and researchers

http://www.jla.nihr.ac.uk/

• INVOLVE UK website for resources on Public and Patient Involvement in research

http://www.invo.org.uk

• How to involve people in research

http://www.invo.org.uk/find-out-more/how-to-involve-people/

Data management and sharing and FAIR principles

• Digital Curation Centre: How to develop a data management and sharing plan and examples

DMPs

http://www.consort-statement.org/

https://www.equator-network.org/library/


https://zenodo.org/about

http://piiaf.org.uk/

http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/involvement-cost-calculator/

http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/involvement-cost-calculator/

http://www.eu-patient.eu/globalassets/projects/valueplus/doc_epf_handbook.pdf

http://www.jla.nihr.ac.uk/

http://www.invo.org.uk/

http://www.invo.org.uk/find-out-more/how-to-involve-people/


73

http://www.dcc.ac.uk/resources/data-management-plans/guidance-examples

• FAIR data principles FORCE 11

https://www.force11.org/fairprinciples

• UK Concordat on Open Research Data (July 2016)

http://www.rcuk.ac.uk/documents/documents/concordatopenresearchdata-pdf/

• Guidelines on FAIR data management plans in Horizon 2020

http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/oa_pilot/h

2020-hi-oa-data-mgt_en.pdf

• FAIR at the Dutch centre for Life sciences

https://www.dtls.nl/fair-data/

• Registry of Research Data Repositories


Gender issues in research

• Examples of case studies in Health & Medicine where gender/sex in research matters

http://genderedinnovations.stanford.edu/case-studies-medicine.html

• Gender Toolkit in EU-funded research for examples and guidance

http://www.yellowwindow.be/genderinresearch/downloads/YW2009_GenderToolKit_M

odule1.pdf

Evidence synthesis

• The Cochrane Library: online collection of databases in medicine and other healthcare

specialties which summarise and interpret the results of medical research.

www.thecochranelibrary.com

• The Campbell Collaboration: promotes positive social and economic change through the

production and use of systematic reviews and other evidence synthesis for evidence-based

policy and practice

https://www.campbellcollaboration.org/

• The Campbell Collaboration UK & Ireland: hub at Queens University Belfast

https://www.qub.ac.uk/research-centres/CampbellUKIreland/

http://www.dcc.ac.uk/resources/data-management-plans/guidance-examples

https://www.force11.org/fairprinciples

http://www.rcuk.ac.uk/documents/documents/concordatopenresearchdata-pdf/

http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/oa_pilot/h2020-hi-oa-data-mgt_en.pdf

http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/oa_pilot/h2020-hi-oa-data-mgt_en.pdf

https://www.dtls.nl/fair-data/


http://genderedinnovations.stanford.edu/case-studies-medicine.html

http://www.yellowwindow.be/genderinresearch/downloads/YW2009_GenderToolKit_Module1.pdf

http://www.yellowwindow.be/genderinresearch/downloads/YW2009_GenderToolKit_Module1.pdf

http://www.thecochranelibrary.com/

https://www.campbellcollaboration.org/

https://www.qub.ac.uk/research-centres/CampbellUKIreland/

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