Continuing review, for studies that require it, is an opportunity for the IRB to reevaluate the study in its entirety to ensure the criteria for approval remain met. The IRB needs complete information about what has happened on the study in the past review period to be able to thoroughly assess the study.
We have added additional language to the CR form’s “Summarize Study Progress” question to elicit more information the IRB needs. Specifically, the following items, at a minimum, should be addressed, covering the most recent review period.
How many subjects:
- Remain on active treatment/intervention
- Completed treatment/intervention during the review period but are still being followed for the study
- Completed the study and any follow-up during the review period
- Withdrew from the study during the review period and summarize the reasons for their withdrawal
- Died during the review period, with a summary of the cause(s) of death and the deaths’ relationship to study participation.
The IRB office may return CR forms during prereview if these items are not addressed.