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Lead Researcher Recordkeeping Responsibilities

Announcements

Overview

The Office of Research (OR) 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 Lead Researcher.

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:

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

Records to Keep Once a Study is Approved by the IRB

When protocol narratives are approved by the IRB:

  • The Human Research Protections (HRP) staff will notify the Lead Researcher and Administrative Contact(s) by e-mail when the approved protocol narrative is available for downloading at the IRB Document Depot.
  • The Lead Researcher should download and save the electronic copy (PDF) of the approved protocol narrative. A copy of the document should also be printed to be retained as a part of the research record.* Only the most current versions of approved documents will be maintained at the IRB Document Depot.
  • The electronic file of the approved protocol narrative should be retained for future IRB submissions (see modifications and continuing protocol submissions below).

When informed consent documents are approved by the IRB:

  • The HRP staff will notify the Lead Researcher and Administrative Contacts by e-mail when the approved consent form(s) are stamped approved and available for downloading at the IRB Document Depot.
  • The Lead Researcher should download and save the electronic copy (PDF) of the approved stamped consent form(s).
  • A copy of the document(s) should also be printed to be retained as a part of the research record.* This stamped consent form should also 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 protocol submissions below).

*For documents approved prior to March 2008, the Lead Researcher should keep the original purple stamped copy for the research record.

Protocol Modifications Submissions

When modifications to approved protocols are submitted to the IRB:

  • Lead Researchers must incorporate requested revisions into the most recently approved electronic file version of the protocol narrative and consent form(s), and 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 narratives and consent forms are performed routinely by HRPP 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 Research for more information.

Continuing Protocol Submissions

When approved protocols are submitted for annual continuing review to the IRB:

  • Lead Researchers should complete the electronic Continuing Protocol Application and provide any additional documentation as necessary. The last approved versions of the protocol narrative and consent form(s) as applicable will be reviewed from the IRB protocol file.
  • See Continuing Review Process for more information.

Records Retention Requirements

Effective April 1, 2020:

In accordance with UC Office of the President policy, research records must be retained for 10 years after the end of the calendar year in which the research is completed unless otherwise specified in the award agreement. 

If research involves the investigation of FDA regulated products: Information/biospecimens must be retained for two years after an approved marketing application. If approval is not received, the information/biospecimens will be kept for 2 years after the investigation is discontinued and the FDA is notified per FDA sponsor requirements.

For more information on UCOP Retention and Disposition Requirements as of October 2018, visit their web page to view the matrix.*

*While signed consent forms are not considered an IRB administrative record for the purposes of this matrix, OHRP and FDA regulations require that signed consent form documents must be retained for a minimum of three years past the completion of a study. If a research study accesses protected health information (PHI) and is covered under the Health Insurance Portability Accountability Act (HIPAA) policy, consent forms are to be retained for a minimum of six years after the completion of a study.

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