Continuing Reviews & Project Closures

 

Continuing review (CR) is a post-approval review process to evaluate if a research study is being conducted in compliance with the approved protocol. This is necessary to ensure the continued validity of ethics approval and to assure the protection and welfare of research subjects.

In line with Singapore's HBRA requirements and general ethics guidelines, NTU-IRB requires all projects approved under the non-Exempt category (i.e. Expedited/Full Board review) to fulfil the following:

  • PIs should submit​ the Continuation Review online form in ERMP. This should be done ​annually, or at intervals appropriate to the degree of risk, until the completion of the study.
  • CR is required until the research study is permanently closed to the enrolment of new research subjects, and all research subjects have completed all research-related interventions/study activities and collection, and analysis of individually identifiable data has been completed.
  • Upon completion of studies, PIs should submit the Project Closure online form in ERMP at the earliest possible time, but not more than 3 months after study completion.
  • For project withdrawals and suspension/ termination, PIs may also use the Project Closure online form in ERMP. This should be reported within 30 calendar days of withdrawal, and 7 calendar days of suspension/termination of the study, respectively.
  • Following reviews by IRB, PIs will be notified of the Continuing Reviews/ Project Closure outcome.

 

NOTE: The NTU-IRB will withdraw the approval or suspend/terminate the study if there is any willful non-compliance to the CR requirement.


Steps on ERMP: