1

New Trials

If you are seeking a collaboration with the UCL CCTU we require you to apply: • At least 3 months before the application

deadline• By using the Collaboration Request Form

available on the website• The completed form should be sent to

cctu-enquiries@ucl.ac.uk

2

New trial adoption process

First steps CI/deputy or Clinical Trial Lead(CTL) (from linked centres)

completes a Collaboration Request Form • Reference # allocated

You will receive a letter from CCTU acknowledging: • The receipt of the proforma• Information of the TPC meeting date when the trial will be

reviewed• Advising that you (or delegate) should attend• A slide set for presentation will be sent

You will also receive a call from CCTU senior staff to discuss suitability and clarify any immediate issues

3

New trial adoption process

The TPC 1st Review meeting consists of:– A short presentation by the Investigator – A discussion with the Investigator– The TPC will then complete a report template

where the following will be considered:• The importance of scientific question• Is the trial feasible?• Is the trial fundable? (in the opinion of the TPC)

4

Supported

• UCL CCTU Interested in developing the trial

• Letter to CI/CTL plus project proposal document• CCTU Project

Manager allocated • PM completes Initial

high level risk assessment with the Investigator

More Information Requested

• More information required to make a decision• Feedback to CI/CTL

from CCTU Director/Deputy Director or TPC Chair

• Then reviewed again by TPC

Not Supported

• Not supported• Feedback to CI/CTL• With summary

recommendations or comments

1st TPC Review ~ outputs

UCL CTU Launch 12 July 2012 5

Supported

• UCL Sponsorship requested?• Yes submission to UCL

sponsorship office• If agreed then proceeds to

funding submission• If no – then sponsor’s

office responds to CI• No CI/CTL confirms

sponsorship arrangement and agreement by UCL

Not Supported

• Not supported• Feedback to CI/CTL

2nd TPC Review – feasibility of conduct

2 possible options based on risk assessment

UCL CTU Launch 12 July 2012 6

IMPORTANT INFORMATION

• Please note. Research Services and the CCTU require pFACT submissions no later than 7 working days prior to the funding deadline.

UCL CTU Launch 12 July 2012 7

New trial adoption process

• If funding successful there will be a 3rd TPC review which will consider:

• The amount of the award• Whether the trial has changed significantly• Are any amendments to the design required?• If the CCTU is still able to manage the trial

8

Last TPC review2 possible options

Supported

• Trial staff recruited• CCTU completes a final risk

assessment • Develop protocol• Approvals• Trial governance structures

established (TSC/IDMC)

Not Supported

• Feedback to CI/CTL• CI to find an alternative

CTU• TPC may recommend

approaching a more appropriate UCL CTU or body

• CCTU will notify other UCL CTU or body of recommendation

UCL CTU Launch 12 July 2012 9

Post Funding

Once the grant has been awarded, the CCTU will :• Apply for sponsorship from, and negotiate IMP

agreements, contracts and site agreements with, the JRO.

• Recruit staff to support the Trial as detailed in the successful grant application.

• Register the Trial on the UKCRC Portfolio of studies.

UCL CTU Launch 12 July 2012 10

Post Funding (cont.d)

• Write the Trial protocol that is compliant with the regulations, CCTU SOPs and policies.

• Submit an IRAS application for Ethics, Clinical Trial Authorisations and NHS Permissions.

• Write project plans, risk assessments, CRFs and monitoring plans.

• Construct a Trial Master File (TMF)• Programme and fully test the database

UCL CTU Launch 12 July 2012 11

Post Funding (cont.d)

• With the CI, engage and organise meetings of the Trial Management Group (TMG), Trial Steering Committee (TSC) and the Independent Data Monitoring Committee (IDMC)

• Train the site(s) on trial protocols, conduct, data capture and GCP

• Work with pharmacy and suppliers to manage drug supply

UCL CTU Launch 12 July 2012 12

Post Funding (cont.d)

• Write TSC / IDMC reports on your behalf• Set up and manage system for recording and

reporting any safety events• Complete update reports for funding body and

REC• Monitor and audit with reports and corrective

action plans as agreed

UCL CTU Launch 12 July 2012 13

Post Funding (cont.d)

The CCTU will also:• Manage Trial close out• Analyse and report the Trial• Manage the archiving of the trial materials• Work with you on the resulting publication

from the Trial