Closing a Study
When your study has concluded and renewed approval is no longer required, it is necessary to submit a Continuing Renewal/Study Closure form to formally close the study with the IRB. The continuing review provides an option to close the study if certain research milestones are complete and renewed approval is not needed.
Record Retention
Investigator Responsibilities: Investigators are required to maintain their research records and the original signed informed consent forms for at least three years after the close of the study or two years after the information is no longer needed for drug or device approval, whichever comes last. Records must be accessible for inspection by authorized representatives of federal or accreditation agencies or departments.
ORIP & IRB Responsibilities: In accordance with federal regulations, all IRB records related to research are maintained intact by the Office for Research Integrity and Protections (ORIP) for at least three years following the close of the study. Records are maintained in a designated storage area or within the electronic protocol tracking system (Infoed).
The ORIP/IRB maintains records for applications that are withdrawn and records for studies cancelled without subject enrollment for three years after cancellation or withdrawal.