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. It is the PI's responsibility to close the study (or the faculty advisor if the PI is a student and has left the university). If you are planning to leave the university, please be sure to close out all your IRB submissions before you leave.
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 Study Closure Application needs to be submitted via the RAP 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.
When submitting a closure report through the RAP, select Modification/CR ⇒ Continuing Review. For additional help, see our guidance on how to close your study in the RAP.
Records
General Information
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, FDA requirements, HIPAA) may apply to the retention of records, for a longer period of time.
Examples of Records that Must be Maintained:
- Signed consent documents (without a link to data) unless consent is waived
- Consent records (e.g., internal documentation tracking how and when consent was obtained) unless consent is waived
- Correspondence between researchers and the IRB
- Information about significant new findings provided to subjects
- Reports of injuries or complaints from subjects
- If a study is FDA regulated, communications and reports to/from FDA
- Monitoring reports, site visit reports, progress reports, audit findings
RCS and the IRB are also responsible for keeping good records about our practices, IRB meeting minutes and other IRB materials such as those described in the federal regulations (e.g., 45 CFR 46.115, 21 CFR 50.115). Our office maintains a digital file for each protocol including a copy of every protocol version submitted to our office (and all accompanying documents), correspondence between our office and the researcher, and any other documents relating to the review of that protocol.
For FDA-Regulated Research
Drugs: In accordance with 21 CFR 312, an investigator or sponsor shall retain the records and reports for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
Devices: In accordance with 21 CFR 812, An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.
Maintaining Research Data
Identifiable Data: If you plan to maintain identifiable private data/specimens, your study may not be able to be closed (e.g., if there is any possibility that the identifiable data/samples may continue to be used, studied or analyzed). If you need to maintain identifiable private data/specimens for safety monitoring procedures but you will not use, study or analyze them, the study can sometimes be closed but there will be limitations on how it can be utilized. If you would like to maintain identifiable data, contact RCS to discuss the specifics of your study.
De-identified Data: Completely de-identified data that is not associated with identifiers directly or indirectly (e.g., no key linking identifiers to coded data or other means to re-identify) can be maintained indefinitely unless your approved research plan, consent form and other IRB approved materials state otherwise. In most cases, researchers can continue to analyze de-identified data after study closure.
If you have questions, please contact Research Compliance Services.