A study is ready to be closed via a Final Review submission when the criteria below are met:
- The study is permanently closed to enrollment, AND
- All subjects have completed research-related interventions or interactions, AND
- All long-term subject follow-up activities are complete, AND
- Identifiable data are no longer needed and all data has been de-identified
Once a study is closed no further human research, follow-up, or analysis of identifiable data can be performed. Letting a study expire is not the same as closing a study. IRB approval must be maintained until the criteria above are met, then investigators should close the study.
To close a study, submit a Final Review submission in eRA, including the Continuing Review e-form. Note that the information requested is the same for a Continuing Review as for a Final Review. Your responses in the Study Details - Current Protocol Status section will determine whether the study meets the criteria for closure and additional information will be requested.
For step-by-step instructions for creating and submitting a Final Review submission refer to the eRA Final Review Submission Guide.