The clinical trial process
There are a number of stages the clinical trial process, before, during and after recruitment.
Definition: A new trial concept, protocol synopsis or full protocol submitted to the TROG Scientific Committee (TSC) for consideration of presentation and subsequent voting by the TROG Membership at the TROG Annual Scientific Meeting (ASM)
Start: New Proposal application form received at TROG's Central Operation's Office (TCOO)
End: New Proposal approved for development
Approved for Development
Definition: This phase commences when a new proposal received the endorsement of TROG Membership at the TROG Annual Scientific Meeting and is approved for development by the TSC.
Start: New Proposal approved for development
End: Trial approved for site activation to commence
Approved for Activation
Definition: This phase commences when a trial in development has met the ten TROG trial development milestones to the satisfaction of the TSC and given permission to commence Site Activation Processes. A TROG number will be allocated at the commencement of this phase.
Start: Trial approved for site activation to commence
End: Activation of first trial site
Open to Accrual
Definition: A trial is considered as open (to accrual) when the first Trial Site has submitted all required regulatory and ethical documentation and has been approved for activation by the Trial Coordinating Centre.
Start: Activation of first trial site
End: Accrual of last patient
Closed to accrual
Definition: A trial is considered closed to accrual after the last patient has been recruited. During the closed phase, patients will complete follow up, the main analyses will occur and processes implemented to complete the trial.
Start: Accrual of last patient
End: Official notification from the TROG Scientific Committee indicating that trial is considered to be completed.
Definition: A trial is considered to be completed when the final follow up has occurred, the trial database has been locked all analyses have been performed and published, trial sites have been closed and records archived.