Closing a Protocol

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Closing a Protocol

For studies previously reviewed and approved by the IRB or determined exempt, the study must be closed once human subject research activities conclude and prior to the study expiration date. Human subject research activities are complete when the research team has finished obtaining data through intervention or interaction with subjects and/or obtaining/using identifiable private information about the subjects (i.e., data has been stripped of any identifiers and any code keys linking the data to the participants are destroyed).

A Closure Report Application needs to be submitted to request closure.  RCS and/or the IRB will conduct a review of the application and verify the study is eligible for closure based on the status of reported activities. Notification of the determination will be provided to the investigator.


Records

Research records must be retained for at least three years after completion of the research and must be accessible for inspection or audit. Other regulations or requirements (e.g. study sponsor) may apply to the retention of records, for a longer period of time.  

Documentation of IRB approval documents, the approved research plan, and informed consent of subjects (without a link to data), are records related to the conduct of research that are typically held, unless the IRB has waived the requirement for informed consent or the requirement of documentation of informed consent.