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Lead Researcher Recordkeeping Responsibilities

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

Researchers are advised to retain all study 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.

UC General Counsel recommends 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.
  • Minors in research: records must be retained for seven years after all minors enrolled in the study reach the age of majority [age 18 in California].
  • Records pertaining to in vitro fertilization studies or research involving pregnant women must be retained 25 years after study closure.

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 UCI.

  • 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.
  • Contractual obligations may require records to be maintained per the agreement with the trial sponsor.
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