Clinical Trial Management

UoB QMS reference number: UoB-CLN-CTM-SOP-001

Purpose:The purpose of this document is to explain how clinical trials should be conducted within the University of Birmingham (UoB). It maps out all aspects of clinical trial management, and explains how different departments within the UoB work together.

Scope:All UoB staff members involved in clinical trials sponsored and managed by the UoB have to follow this procedure, focussing on those aspects of this procedure that cover their day to day work. Where clinical trials are (co-)sponsored and/or (partially) managed by another institution, this procedure should be followed as far as possible.

Implementation plan:The implementation period is 2 weeks after the completion date to allow for the procedure to be embedded in local structures.Thereafter -

For new trials identified prior to any grant application, follow the processes from ‘Idea’ onwards.

For trials in the phase of grant application, follow the processes from ‘Award receipt and distribution’ onwards, and follow any previous processes as far as possible.

For trials in their set up phase, ensure any regulatory requirements are met, follow the processes ‘Site initiation to archiving’ and onwards, and follow any previous processes as far as possible.

For ongoing trials and trials in the closure phase, ensure any regulatory requirements are met, follow the process ‘Amendments’, and supply information to Sponsor as requested on the process map ‘Site initiation to archiving’.

Date of implementation:01-May-2016

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Responsibilities:Given the complexity of this procedure, a colour coding has been used to identify individuals/teams and their role in the procedure. Below is a summary of their responsibilities and the colour coding used for the individual/team. In addition, where an individual/team other than the CI is to undertake an activity, this will be written in italics, and the relevant individual/team is mentioned in the actual text.

Chief Investigator or delegateThe Chief Investigator (CI) is responsible for the initiation, conduct and completion of the clinical trial. They may however delegate tasks. Delegates may include trial team members, who may be based in a Clinical Trials Unit (CTU). Where the CI does not hold a contract with the UoB and the UoB takes on trial management, it would be expected the CI works together with a UoB Lead, who may also be delegated certain tasks. Specific tasks are indicated in the procedure in black text.

Research Support Partner, Research Facilitator, Research AdministratorEach College within the UoB has a Research Support Partner, who works closely together with the College’s Director of Research and Knowledge Transfer, contributing to the College’s Research and Knowledge Transfer strategy and dealing with associated matters. The Research Support Partner may take on the role of Research Facilitator and/or may manage a team to include Research Facilitators. The team supports research in the College by functioning as the first point of contact, both internally and externally, for advice and assistance with all research-related issues. The team also provides information to their researchers regarding research funding, and provides an essential interface with relevant corporate services. In the College of Medical and Dental Sciences (MDS), the team includes a Research Administrator (a central administrative post). In the College of Life and Environmental Sciences (LES) the post of Research Administrator is covered by the Research Support Partner. Specific tasks are indicated in the procedure in green text.

Clinical Research Compliance TeamThe Clinical Research Compliance Team forms part of the MDS Research and Knowledge Transfer (R&KT) Office, and is responsible for developing an infrastructure for researchers involved in clinical research, helping to ensure clinical research projects and in particular clinical trials are conducted in line with any applicable regulations, international standards and University standards. This is done through the development of the Quality Management System (QMS), monitoring, and responsibilities relating to Sponsor oversight such as audits and quality checks.Specific tasks are indicated in the procedure in red text.

Research Governance TeamThe Research Governance Team (RGT) is responsible for Sponsorship decisions and confirmation of Sponsorship on behalf of the UoB, signing-off any applications for approval/authorisation as Sponsor representative, issuing Trial Specific Template Site Agreements, and for maintaining Sponsor oversight. The Research Governance Team is also responsible for processing any requests for clinical trial insurance via their Research Insurance Administrator. Specific tasks are indicated in the procedure in light blue text.

Research Finance OfficeThe Research Finance Office is responsible for providing staff costs and advice on funder rules for research applications, setting up trial accounts, and all other pre- and post-award financial administration.Specific tasks are indicated in the procedure in purple text.

Research Ethics TeamThe Research Ethics team is responsible for the operation of the University’s internal ethical review processes, including the administration of the UoB Ethical Review of Research Self Assessment Form (SAF) and the co-ordination of applications requiring further review by an internal ethical review committee.Specific tasks are indicated in the procedure in dark blue text.

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Research Contracts TeamThe Research Contracts team is responsible for drafting, reviewing and negotiating contracts with funders and other collaborating parties, ensuring that the University and individual researchers are protected from contractual risks and liabilities. The team is also responsible for approving the final agreement for signing by an authorised signatory (usually the Deputy Director of Finance or Head of Research Support Group).Specific tasks are indicated in the procedure in orange text.

Procedure: Explanatory notes The procedure consists of several flowcharts. The first flowchart is a summary; with each

coloured box being detailed further in subsequent flowcharts:o The ‘Pre-award clinical research governance check’ flowchart and links are highlighted in pinko The ‘UoB procedures – award receipt and distribution’ and ‘UoB procedures – towards

account set up’ flowcharts and links are highlighted in orangeo The ‘Trial set up’ flowchart and links are highlighted in greeno The ‘Site initiation to archiving’ flowchart and links are highlighted in blueo The ‘Amendments’ flowchart and links are highlighted in yellow

Within the UoB different teams/offices are responsible for undertaking specific tasks relating to clinical trials. Average timelines have been added to the flowcharts to create clarity to the CI and their team as to when they can expect results, and when it would be appropriate for them to check on the progress with the relevant team/office.

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Procedure summary

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Pre-award clinical research governance check

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UoB procedures – award receipt and distribution

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UoB procedures – towards account set up

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Trial set up

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Site initiation to archiving

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Amendments

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Procedures required from trial set up through to archiving:Ensure the following procedures are followed throughout the trial, from trial set up to archiving; SOPs referenced are available at: http://www.birmingham.ac.uk/research/activity/mds/mds-rkto/governance/Clinical-Trials-QMS.aspx:

Set up and maintain a Data Monitoring Committee and other committees as appropriate, e.g. Trial Steering Committee, Trial Management Group; see UoB-CLN-TQM-SOP-001 Trial Quality Management

Set up and maintain a Trial Master File and Investigator Site Files; see UoB-CLN-ESD-SOP-001 Essential Documents development and maintenance

Develop Case Report Forms; see UoB-CLN-CRF-SOP-001 Case Report Form development

Set up data management and tracking systems; see UoB-CLN-TSM-SOP-001 Trial Systems development and management

Ensure the following topics are covered either in SOPs, trial specific guidelines or in the protocol:o Plan for statistical analysis where applicable; see UoB-CLN-STA-SOP-001 Statistics o Management of trial quality, including monitoring and quality checks; see UoB-CLN-TQM-

SOP-001 Trial Quality Management o 24 hour emergency coverage procedures (site/coordinating centre); see UoB-CLN-CTM-

SOP-002 Randomisation and Blinding o For blinded trials, procedures relating to blinding and (emergency) unblinding; see UoB-CLN-

CTM-SOP-002 Randomisation and Blinding o Registration/Randomisation procedures; see UoB-CLN-CTM-SOP-002 Randomisation and

Blindingo Pharmacovigilance procedures; see UoB-CLN-AES-SOP-001 Adverse Event reportingo Ongoing review of trial supplies management, for CTIMPs including IMP management; see

UoB-CLN-IMP-SOP-001 Investigational Medicinal Product Managemento Regular review of the trial risk assessment; see UoB-CLN-TQM-SOP-001 Trial Quality

Managemento Financial and resource management

External review of (aspects of the) trial, including funding bodies, Data Monitoring Committee, REC and CA review; ensure any required reports for such review are generated within the expected timeframe, for example the Annual Progress Report and the Development Safety Update Report (DSUR); also see UoB-CLN-AES-SOP-001 Adverse Event reporting

Provide training to trial staff; see UoB-GEN-TRN-SOP-001 Training

Provide training to site staff; see UoB-CLN-SMA-SOP-0001 Site Management

Maintain all essential documents in the Trial Master File; see UoB-CLN-ESD-SOP-001 Essential Documents development and maintenance

Adverse Event monitoring and reporting, ensuring the required timelines are met; see UoB-CLN-AES-SOP-001 Adverse Event reporting

Process any suspected Serious Breaches within the required timelines and as per REC guidelines and for CTIMPs as per MHRA guidelines; see UoB-CLN-SBR-SOP-001 Serious Breach reporting

Protocol defined statistical analysis

Vendor Management; see UoB-CLN-VEN-SOP-001 Vendor Management

End of Trial Processes; see UoB-CLN-EOT-SOP-001 End of Trial management

Archiving; see UoB-CLN-ARC-SOP-001 Archiving

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Related documents:Links below were correct at time of writing:

Pre-award Research Governance Checklist: available from Research Governance Team

College of Medical and Dental Sciences Application for Research Grants and Contracts Approval Form (Pink Form): http://mymds.bham.ac.uk/portal/staff/researchgrants/

Clinical Trials Oversight Committee Terms of Reference: available from the Clinical Research Compliance Team

Sponsorship Review Criteria: available from the Research Governance Team

Sponsorship Application Form (PF2 and PF3) and the CI Declaration Form: https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Research-Governance/UoB-Sponsorship.aspx

UoB SAF: https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Research-Ethics/Ethical-Review-Forms.aspx

Insurance Questionnaire: https://intranet.birmingham.ac.uk/finance/insurance/Clinical-Trials.aspx

Request for Contract Services. https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Contracts/Request-a-Contract.aspx

MHRA Instructions and Template for Serious Breach reporting http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice/SeriousBreachesReporting/index.htm

Annual Progress Report (of NRES). http://www.nres.nhs.uk/applications/after-ethical-review/annual-progress-reports/

Declaration of end of a Clinical Trial Form. http://www.nres.nhs.uk/applications/after-ethical-review/endofstudy/

NRES Declaration of the end of a Clinical Study Form. http://www.nres.nhs.uk/applications/after-ethical-review/endofstudy/ (National Institute for Health Research, 2013)

University of Birmingham Quality Management System (QMS) Standard Operating Procedures, available at: http://www.birmingham.ac.uk/research/activity/mds/mds-rkto/governance/index.aspxo Clinical Trials Quality Manualo UoB-CLN-CTM-QCD-002 Clinical Trials Task Delegation Logo UoB-CLN-PRO-QCD-002 Protocol Template - CTIMPso UoB-CLN-CTM-SOP-002 Randomisation and Blindingo UoB-CLN-TQM-SOP-001 Trial Quality Managemento UoB-CLN-ESD-SOP-001 Essential Documents development and maintenanceo UoB-CLN-CRF-SOP-001 Case Report Form developmento UoB-CLN-DMA-SOP-001 Data Managemento UoB-CLN-IMP-SOP-001 Investigational Medicinal Product Managemento UoB-CLN-TSM-SOP-001 Trial Systems development and managemento UoB-CLN-SMA-SOP-001 Site Managemento UoB-CLN-AES-SOP-001 Adverse Event Reportingo UoB-CLN-AES-QCD-004 DSUR Templateo UoB-CLN-STA-SOP-001 Statisticso UoB-CLN-SBR-SOP-001 Serious Breach reportingo UoB-CLN-ARC-SOP-001 Archivingo UoB-CLN-EOT-SOP-001 End of Trial managemento UoB-CLN-VEN-SOP-001 Vendor Management

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References: University of Birmingham Finance Office teams:

o Research Governance Team: https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Research-Governance/index.aspx

o Research Ethics Team: https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Research-Ethics/Ethical-Review-of-Research.aspx

o Research Contracts Team: https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Contracts/contracts.aspx

o Research Finance Office: https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Research-Finance/research-finance.aspx

Birmingham Region Research and Training Collaborative. (2013). Research Training. Retrieved November 9th, 2015, from Birmingham Region Research and Training Collaborative: http://brtc.org.uk/

Clinical Research Compliance Team. (2013). Clinical research, clinical trials and governance. Retrieved November 9th, 2015, from University of Birmingham: http://www.birmingham.ac.uk/research/activity/mds/mds-rkto/governance/index.aspx

Department of Health. (2005, April). GOV.UK. November 9th, 2015, from Research Governance Framework for health and social care: second edition: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh_4122427.pdf

European Committee. (2011). ‘Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use. Retrieved November 9th, 2015, from Eudralex Volume 10: http://ec.europa.eu/health/files/eudralex/vol-10/2011_c172_01/2011_c172_01_en.pdf

European Committee. (2003, October 14). Comission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Retrieved November 9th, 2015, from Eudralex Volume 10: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf

European Committee. (2006, July). Recommendation of the content of the Trial Master File and Archiving. Retrieved November 9th, 2015 from http://ec.europa.eu/health/files/eudralex/vol-10/v10_chap5_en.pdf

HRA approval process (2016, March): http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment-approval/

MDS Research and Knowledge Transfer Office. (2013). Research Development and Contracts. Retrieved November 9th, 2015, from MDS Reseach and Knowledge Transfer Office: http://www.birmingham.ac.uk/research/activity/mds/mds-rkto/research-development/index.aspx

MHRA. (2010, June 14). Clinical trials for medicines: Legislation. Retrieved November 9th, 2015, from MHRA: https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials

MHRA. (2011, July 11). How we regulate devices. Retrieved November 9th, 2015 , from MHRA: https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety /

National Institute for Health Research. (2013). Pharmacovigilance. Retrieved November 9th, 2015, from Clinical Trials Toolkit: http://www.ct-toolkit.ac.uk/routemap/pharmacovigilance

National Institute for Health Research. (2013). Trial Management & Monitoring . Retrieved November 9th, 2015, from Clinical Trials Toolkit: http://www.ct-toolkit.ac.uk/routemap/trial-management-and-monitoring

National Institute for Health Research. (2013). Trial Supplies. Retrieved November 9th, 2015, from Clinical Trials Toolkit: http://www.ct-toolkit.ac.uk/routemap/trial-supplies

University of Birmingham. (2012-2013). Code of Practice for Research. Retrieved November 9th, 2015, from http://www.birmingham.ac.uk/Documents/university/legal/research.pdf

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University of Birmingham Procurement process. Retrieved November 9th, 2015: https://intranet.birmingham.ac.uk/finance/procurement/Procurement-Services.aspx

Note the Clinical Trials Toolkit contains references to any applicable regulations and (inter)national guidance relating to clinical trials. These are reiterated in the UoB Clinical Trials Quality Manual.

Abbreviations and Definitions:Term DescriptionARSAC Administration of Radioactive Substances Advisory Committee

BRTC Birmingham region Research Training CollaborativeThe BRTC supports the delivery of high quality clinical research in its member organisations by providing access to research related training activities and a communication forum whereby learning resources and local events can be shared.

Chief Investigator

The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design, conduct and reporting of the study, whether or not that person is an investigator at any particular site.Note that for CTIMPs the Chief Investigator must be an authorised health professional.

CA Competent Authority

CI See ‘Chief Investigator’

Clinical research Any health related research on humans.

Clinical study Any health related research study on humans. This includes: Study administering questionnaires/interviews for quantitative analysis,

or using mixed quantitative/qualitative methodology Study involving qualitative methods only Study limited to working with human tissue samples (or other human

biological samples) and data (specific project only) Study limited to working with data (specific project only)

Clinical trial For clinical trials using an Investigational Medicinal Product:Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.

For all other clinical trials:Prospective biomedical research on human subjects that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions. Examples include devices, surgery and radiotherapy trials.

Clinical Trial Task Delegation Log

A UoB document that defines all Clinical Trials tasks and how these are delegated between CI and CTU

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Clinical Trials Oversight Committee

The Clinical Trials Oversight Committee (CTOC) provides sponsor oversight of UoB’s portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs). The CTOC also provides a means for the Research Governance Team to obtain expert advice relating to non-CTIMPs. The CTOC reports to the Pro-Vice Chancellor for Research & Knowledge Transfer through the University Research Governance and Ethics Group, and to the University of Birmingham Internal Audit Office.

CTIMP A Clinical Trial of an Investigational Medicinal Product

CTOC See: ‘Clinical Trials Oversight Committee’

CTU Clinical Trials Unit

CTU managed study

A study for which the overall study management or the majority of study management duties has been delegated to the CTU on behalf of a Sponsor. Examples include all or most of the activities of Registration, Site Initiation, Monitoring, IMP supply, Pharmacovigilance, Data Management and Statistical Analysis.

DSUR Development Safety Update Report

ERN Ethics Registration Number; an internal number assigned to a project following completion of a UoB Ethical Review of Research Self Assessment Form

HRA Approval The process for the NHS in England that comprises a review by a NHS Research Ethics Committee (REC) (where required) as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. In England, it replaces the need for local checks of legal compliance and related matters by each participating NHS organisation.

IRAS Integrated Research Application System; set up to streamline the research application process in the UK

IRMER The Ionising Radiation (Medical Exposure) Regulations 2000

LES College of Life and Environmental Sciences

MDS College of Medical and Dental Sciences

MHRA Medicines and Healthcare products Regulatory Agency; the Competent Authority in the UK

NIHR National Institute for Health Research

Pink Form College of Medical and Dental Sciences Application for Research Grants and Contracts Approval Form; this is a college specific form that facilitates the review, approval and tracking of any new grant proposals and is commonly known as ‘Pink Form’.

R&KT Office Research & Knowledge Transfer Office

RA1 Form Research Activation Form used by the Research Finance Office to document that an account has been set up and listing the account code.

REC Research Ethics Committee

RG Number Research Governance Number; the number that the Research Governance Team will assign to any project put forward for UoB Sponsorship

RGT See: ‘Research Governance Team’

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Research Facilitator

The Research Facilitator acts as the central contact point in project development, initiation and conduct. The Research Facilitator liaises with relevant contacts e.g. Finance Office, peer review and any other internal or external bodies which may be able to assist. Different Colleges may use different job titles for the same role.

Research Support Partner

The Research Support Partner is responsible for ensuring research in the College is supported by providing the first point of contact, both internally and externally, for advice and assistance with all research-related issues, by providing up to date information regarding research funding. Different Colleges may use different job titles for the same role.

SAE Serious Adverse Event

SAF UoB Ethical Review of Research Self Assessment Form

SUSAR Suspected Unexpected Serious Adverse Reaction

UKCRN UK Clinical Research Network

UoB University of Birmingham

UoB CTU One of the three UKCRN fully registered University of Birmingham Clinical Trials Units, i.e. Cancer Research UK Clinical Trials Unit (CRCTU), Birmingham Clinical Trials Unit (BCTU) or the Primary Care Clinical Research and Trials Unit (PC-CRTU).

UoB Lead The UoB Lead is a (senior) person in the UoB who takes responsibility for the conduct and delivery of those parts of the study which are either carried out at or managed/overseen by the UoB. Normally this would be an academic researcher, but in some cases it may be a senior member of a UKCRC registered UoB CTU.

See also Glossary of Terms.

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Development summary:

Author:Name: Conor McGoldrick Signature: See original copy

Function: Clinical Trials Compliance Officer

Date: See original copy

Reviewed by: Wilma van Riel, Head of Clinical Research ComplianceClinical Trials Oversight Committee

Authorised by:Name: Prof. Julian Bion on behalf of CTOC Signature: See original copy

Function: Chair of the Clinical Trials Oversight Committee

Date: See original copy

Name: Wilma van Riel Signature: See original copy

Function: Head of Clinical Research Compliance

Date: See original copy

Issue date: 13-Apr-2016

Supersedes:UoB-CLN-CTM-SOP-001, Clinical Trial Management v. 4.0

Reason for update:

Update to include the introduction of the process for HRA approval to replace the requirement for NHS permissions

Review of final version:Date: Reviewed by: Signature: Outcome:

N/A

Editorial Amendments Tick box if not applicable

Reason for update:

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Update to QMS coding and references to Protocol Template and Case Report Form SOP

Date of amendment:

Supersedes:UoB-CLN-CTM-SOP-001 v5.0 dd 010516

Editor:Name: Conor McGoldrick Signature: See original QAF

Function: Clinical Trials Compliance Officer

Date: See original QAF

Authoriser:Name: Wilma van Riel Signature: See original QAF

Function: Head of Clinical Research Compliance

Date: See original QAF

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