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
1
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
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)
3
1st TPC Review ~ outputs
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
4
2nd TPC Review – feasibility of conduct
2 possible options based on risk assessment
Supported
Not 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
• Feedback to CI/CTL
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5
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
6
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
UCL CTU Launch 12 July 2012
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Last TPC review
2 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
8
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.
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9
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
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10
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
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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
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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
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