The Institutional Review Board (IRB) maintains an official protocol file for each study to meet the University's regulatory obligations for record keeping.  The IRB staff is not responsible for maintaining study documents for the researchers, or for providing copies of official documents to research staff.  Keeping accurate and complete protocol records is the responsibility of the Principal Investigator.
The following guidelines are provided to assist investigators and research staff with recordkeeping of approved IRB protocols documents and to facilitate submissions of correct versions of protocol documents for the life of the study.

Records to Keep While a New Study is Being Reviewed by the IRB

When new protocols are submitted to the IRB: 

• Researchers should keep electronic files of all protocol documents (e.g., application, protocol summary, informed consents, recruitment materials, etc.) in order to make requested revisions that may be required for IRB approval.
  
• Researchers should keep electronic files of IRB approved protocol documents, in order to make revisions to approved protocols for modifications and the continuing renewal of the protocol (see below).

Records to Keep Once a Study is Approved by the IRB

When protocol summaries are approved by the IRB:

• The approved protocol summary should be retained by the PI as a part of the research record.
  
• The electronic file of the approved protocol summary should be retained for future IRB submissions (see modifications and continuing review below).

When informed consent documents are approved by the IRB:

• IRB staff stamp the approved version of the consent form(s) and send an original stamped hard copy back to the PI.
  
• This original stamped consent form should be used to make copies of the consent for enrolling research participants.
  
• The electronic file of the consent form(s) should be retained for future IRB submissions (see modifications and continuing renewal below).

Protocol Modification Submissions

When modifications to approved protocols are submitted to the IRB:

• Researchers should incorporate requested revisions into the most recently approved electronic file version of the protocol summary and consent form(s), and into other protocol documents, as applicable.
  
• Note that some studies are modified frequently and the most recent approved version must be used for each modification request.
  
• Version checks of protocol summaries and consent forms are performed routinely by IRB staff. Revisions submitted on older versions of the protocol narrative cannot be reviewed by the IRB and will be returned for correction.

See Modifications to Approved Protocols  for more information.

Continuing Review Submissions

When approved protocols are submitted for annual continuing review to the IRB:
Researchers must include the most recently-approved version of the protocol summary and consent form(s), and other protocol documents, as applicable.
Version checks of protocol summaries and consent forms are performed routinely by IRB staff. Continuing renewal applications submitted with older versions of the protocol narrative cannot be reviewed by the IRB and will be returned for correction.

See Continuing Review  for more information.

Tips for Keeping Approved Electronic Files of Protocol Documents

• Use the revision date area of the protocol summary to keep track of submissions to the IRB.
  
• Use a footer with the date of submission on consent forms and other documents submitted for approval.
  
• Update electronic file names with a version approval date once hard copy approved versions are received from the IRB.

Records Retention Requirements

Researchers are advised to retain all study-related records for a minimum of three years past the close of the study. This includes approved IRB documents, as well as case-report forms, tapes or transcripts, and all other data-collection instruments and source documents.

• We recommend longer retention periods for certain research records:
  
• Records involving the generation, disclosure, and/or use of Protected Health Information (PHI) should be retained for six years.
  
• Contractual obligations may require records to be maintained per the agreement with the trial sponsor.
  
• Minors in research: records should be retained for seven years after all minors enrolled in the study reach the age of majority.
  
• In the case of FDA-regulated studies, investigators are required by regulation to retain records for periods which may be significantly longer than six years after study closure of the IRB protocol at UT Southwestern.
   
  • For drugs which the marketing application is approved, the retention period is two years after FDA approval.
    
  • For drugs where no application is filed or the application is not approved, the retention period is two years after the investigation is discontinued and FDA is notified.