Guidance

Record Keeping Guidelines

IRBMED
Jan 3, 2008 2:45 pm

Investigators frequently ask how long they should keep research records after a study has ended. Because different regulations apply to different types of studies there is not a simple answer to this question.

Ten years is a safe default standard, however, 10 years could be longer than what is required for many studies (note--gene therapy studies and those where the research may have contributed to a minor's incompetency have longer requirements as noted below).

The chart below lists types of records to keep and the different criteria that apply (or click here for a printer-friendly version). If you need further assistance contact the Health System Legal Office.

Compare record-keeping requirements below each study descriptor that applies to a study; keep records for the longest period indicated. Note that records generated under a grant or contract with an industry, government, foundation, or other sponsor may require longer retention, depending on the terms and conditions of the grant or contract.

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: sophiach@umich.edu
Last Updated: May 24, 2018 2:00 PM