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APPROVED FOR DEVELOPMENT Insert full trial title Insert Name of Trial Chair/s.

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Presentation on theme: "APPROVED FOR DEVELOPMENT Insert full trial title Insert Name of Trial Chair/s."— Presentation transcript:

1 APPROVED FOR DEVELOPMENT Insert full trial title Insert Name of Trial Chair/s

2 acronym: Trial Summary  Include your rationale for performing the trial

3 acronym: Interested Sites  Date sites surveyed  Number of sites that expressed interest  List sites

4 acronym: Protocol  Consider discussing: Current status Timeline for completion Obstacles experienced and how they were overcome, or Plan for overcoming existing obstacles What was done well?

5 acronym: Statistical  Include – number of patients, accrual time frame, follow-up time frame – Brief trial design – Randomisation methods if applicable – Any other statistical issues that the membership needs to be aware of

6 acronym: Funding  Include – Funding secured – Funding pending – Future funding considerations – What will the capitation be per site?

7 acronym: Trial Management Committee  Include – TMC members (list and include states/countries they represent) – Meetings held

8 acronym: Trial Coordinating Centre  Name of Coordinating Centre  Contact person – Phone –

9 acronym: Quality Assurance  Include – Credentialing requirements – Any other QA that will be specific to this trial and involve trial sites

10 acronym: CRFs and Database  What is the status of CRF development? i.e. to commence when funding is secured, in development, complete  What kind of database will be used? e.g. TROG CTDS, GCP compliant MS Access Database.  Status of database development (if CRFs are compete)

11 acronym: When can we accrue?  Include a summary of what needs to be done and a timeline – Protocol to be completed by – month / year (approx.) And submitted to TSC for a TROG number – Funding announced – month / year (approx.) – Sites to be resurveyed - month / year (approx.) – Contracts to be arrange - month / year (approx.) – Ethics application submitted - - month / year (approx.)


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