The REB must be advised of all study closures (to accrual permanently or temporarily, and permanently closed). A study closure report should be submitted in ROMEO.
Study Closed to Accrual
The REB must be advised if a study closes to accrual permanently or if accrual is temporarily suspended. A change in study status report should be submitted in ROMEO.
- The study was never initiated and there are no plans to do so in the future.
- The research project is no longer collecting data about research participants, which includes entering, collecting and verifying data, and there is no longer a need to obtain more data for the research project.
- The study is interrupted unexpectedly (e.g., the sponsor withdraws support, the investigational agent is no longer available, etc.).
A study closure report should be submitted in ROMEO.