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 cctu-enquiries@ucl.ac.uk 1

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 2

3. New trial adoption process The TPC 1 st 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) 3

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 4

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 2 nd TPC Review – feasibility of conduct 2 possible options based on risk assessment UCL CTU Launch 12 July 20125

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 20126

7. New trial adoption process If funding successful there will be a 3 rd 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 7UCL CTU Launch 12 July 2012

8. Last TPC review Last TPC review 2 possible optionsSupported 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 8

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 20129

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 201210

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 201211

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 201212

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 UCL CTU Launch 12 July 201213