Presentation on theme: "APPROVED FOR DEVELOPMENT Insert full trial title Insert Name of Trial Chair/s."— Presentation transcript:
APPROVED FOR DEVELOPMENT Insert full trial title Insert Name of Trial Chair/s
acronym: Trial Summary Include your rationale for performing the trial
acronym: Interested Sites Date sites surveyed Number of sites that expressed interest List sites
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?
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
acronym: Funding Include – Funding secured – Funding pending – Future funding considerations – What will the capitation be per site?
acronym: Trial Management Committee Include – TMC members (list and include states/countries they represent) – Meetings held
acronym: Trial Coordinating Centre Name of Coordinating Centre Contact person – Phone – Email
acronym: Quality Assurance Include – Credentialing requirements – Any other QA that will be specific to this trial and involve trial sites
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)
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.)