XII Study Closure, Data Retention and Expired Studies

Study Closure: A study is completed when enrollment of participants and data collection are complete and data analysis is to the point that participants’ records will no longer be required. Once a study is closed, no further research related activities can occur. A Final Study Report must be submitted to the IRB within 30 days of closure of the study via eIRB, (click on the create Final Report option in your study workspace) or on paper (click here to complete a Final Report form) if your study was originally submitted on paper.   Notification of the closure of exempt studies is also recommended.

Data Security and Record Retention: After your study is closed there are continuing regulatory responsibilities related to data security and record retention. Investigators are required to maintain records of their human-subjects research activities. Good records are essential for verifying the quality of study data produced and demonstrating investigator compliance with good clinical practice guidelines and applicable regulatory requirements. In general, investigators should establish two sets of files for each study: Regulatory documents and Study subject information.

• Regulatory documents should be maintained for all studies, regardless of whether the research is funded or unfunded for at least three years after completion of the research.
• Study subject information is subject to HIPAA requirements which requires that research records including signed consent forms that contain the HIPAA authorization must be retained for 6 years after the date on which the subject signed the consent form or the date when it last was in effect, whichever is later.

Expired Studies: If your study expires before it obtains an approved continuation, please follow the guidance on this website. You can access the Expired Study Form here.

Questions/Need additional information? Please let us know.