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New Trials

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 c ompleted form should be sent to cctu-enquiries@ucl.ac.uk.

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New Trials

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  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. 1st TPC Review ~ outputs

  5. 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 successfulthere 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 UCL CTU Launch 12 July 2012

  8. Last TPC review2 possible options

  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 UCL CTU Launch 12 July 2012

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