Study Closure

Fiscal Management

Approaching the end of grant term make sure all of your subcontracts that have been invoiced for their work are completed and received. Do not leave large encumbrances. Researchers should also follow the Award Closeout Process.

Maintenance and Storage of Research Records

Under Maintenance and Storage of Research Records - update to state "Research records must be maintained per FDA regulations, IRB policy and institutional policy. Many departments are contracted with Records Control (formerly Fireproof). Records Control can be contacted at 614-299-2122.

It is important for study teams to keep a log of where the records are stored, what is in each box, and how to retrieve the records at a later time.

Research records must be maintained per FDA regulations, IRB policy and institutional policy.

• FDA Regulated Drug Studies - The Investigator/Sponsor must maintain all records for at least two years after the New Drug Application (NDA) has been approved, or if a NDA is not approved for the drug until 2 years after shipment and delivery of the drug for investigational use is continued and the FDA has been notified.
• FDA Regulated Device Studies - The Investigator/Sponsor must maintain all records for at least two years after the latter of the following two dates: 
  • The date on which the investigation is terminated or completed
  • The date that the records are no longer required for purposes of supporting a premarket approval application (PMA), a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission or a request for De Novo classification.
• Ohio State IRB policy - The investigator will retain
  • Research-related records (protocol, IRB correspondence, etc.) for at least three years after the research has ended
  • Consent forms/HIPAA authorizations for at least six years after the study has closed
  • Primary research data (source documentation and case report forms) for five years after final project closeout. 
• The Ohio state University Records Management Policy can be found at policies.osu.edu. 

ClinicalTrials.gov

For Investigator Initiated Trials (IITs) the Principal Investigator (The Responsible Party) is responsible for entering the study results in ClinicalTrials.gov within 1 year of meeting the primary completion date, for all NIH sponsored Clinical Trials, and for any Clinical Trial that is an Applicable Clinical Trial (ACT).

Primary Completion Date - the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome measure.

Training for entering study results in ClinicalTrials.gov can be found below.

Regulatory Closeout

Investigator Site File (ISF)

The Principal Investigator (PI) should ensure all the essential documents are collected and filed. Stop dates for all study team members should be added to the Delegation of Authority (DOA) log. A final Financial Disclosure Form (FDF) should be collected from all investigators working on the study within one year of study closure.  

For multi-site studies the PI is responsible for collecting all sub-site essential documents for the Master Trial Folder (MTF).

FDA Closeout

Investigators holding an IND/IDE with the FDA must submit their IND withdraw or IDE Final Report.  For assistance with preparing a FDA closeout submission please place a request.

IRB Closeout

Investigators should submit a study termination notification to the IRB of Record.  For Investigators overseeing multi-site Investigator Initiated Trials (IITs) they need to ensure all sub-sites close have complete.   

IACUC/IBC Closeout

For studies that include IACUC and/or IBC reviews, the study closures should be completed in the IACUC and/or IBC portals and records should be saved and maintained.