Study Closure

Please note:

• Your IRB-approved study data (records, bio-specimens etc.) is property of Rutgers University and permission is required to retain a copy of the data or share the data including when de-identified.
• The FDA may audit IRB-related records at any time during this period and records must be available.
• All IRB Records must be secured manner that assures only authorized personnel will have access.
• IRB-related Study Records must be stored in a secure Rutgers approved location which must be accessible by your Supervisor and Rutgers Department.

There are specific IRB-related requirements of different retention periods for research records.  Please see "Data Retention and Record Keeping" under HRPP/IRB’s Guidance Topics for specific IRB-research record retention schedules.

You may continue data/specimen analysis after your study has been closed with the IRB if all identifiers and data links have been destroyed.

Please note: Data or specimens may still contain data elements protected under HIPAA.

For Applicable Clinical Trials

For certain clinical trials subject to the requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), Responsible Parties must submit scientific and administrative information about the results of the trial to the ClinicalTrials.gov results database.

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Make sure to review any actions which your study's Sponsor requires when you close your study.