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Study Closure
 
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.
 
Open this hyperlink to access a pdf. of the change in study status signature page

Permanent Study Closure

A study should be permanently closed, if:
  • 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.
 
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