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IRB-HSR > Managing Protocol After Initial Approval > Recordkeeping Responsibilities

 

 

 

 

 

 

Recordkeeping Responsibilities

Overview

The 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 study team.

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

The study team should keep electronic files of all study documents (e.g., protocol, informed consents etc.) in order to make requested revisions that may be required for IRB approval.

Records to Keep Once a Study is Approved by the IRB

Hard Copies

  • If applicable: Consent(s) with Approval Stamp. This original stamped consent form should be used to make copies of the consent for enrolling research participants.
  • All documents previously submitted to the IRB.
  • All documents received from the IRB.

Electronic Copies

  • The electronic file of the currently approved protocol and consent form(s) if applicable should be retained for future IRB submissions such as modifications or continuations.

Protocol Modifications Submissions

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

Continuing Renewal Submissions

  • The study team must keep copies of all documents, including the Status Forms, submitted to the IRB at the time of the continuation review.

Record Retention Requirements

DHHS Regulated Studies

Requirements for record retention vary with

  • the type of research conducted,
  • provisions of the investigators funding source, and
  • the requirements of the investigators professional association.

DHHS regulations do not clearly address the issue of the length of time a principal investigator should maintain research records after completion of all research activities related to a study.

However, the University of Virginia record retention guidance does address the issue of retention of research records.

The guidance states that records should be kept a minimum of two (2) years after submission or publication of the final project report for which the data were collected, whichever is longer.

If a research study involves health information that was not de-identified, the records must be kept for six (6) years from the date the study was closed with the IRB.

If retention requirements specified in a funding agency's regulations are longer, the agency requirements will apply.

In addition, at the discretion of the investigator, some data may be retained longer for use in subsequent projects.

All records must be accessible for inspection and copying by authorized representatives of the IRB, regulatory agencies and sponsor.

FDA Regulated Studies

For studies regulated by the FDA, the investigator or sponsor shall maintain the records during the investigation and for a period of 2 years after the latter of the following dates:

  • the date on which the investigation is terminated or completed, or
  • the date that the records are no longer required for purposes of supporting a pre-market approval application or
  • a notice of completion of a product development protocol.

An investigator or sponsor may withdraw from the responsibility to maintain records for the period required and transfer custody of the records to any other person who will accept responsibility for them including the requirements of 21CFR812.145. Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.

*Taken from UVa IRB-HSR Research Guidance