Guidance

Record Keeping Guidelines

IRBMED
Mar 8, 2021 2:00 pm

 

Research records include, but may not be limited to,

  • consent forms
  • case report forms (CRFs)
  • subject-specific forms for adverse events, notes to file, and protocol deviations

Records may be kept in hard-copy or electronically.

Record retention must be consistent with

  • Guidelines

    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 (VPN or on-campus access required) at (734) 764-2178 .

    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.

    Record Keeping Guidelines

    Study Descriptors

    What to keep

    Federally Funded All Data Abstracted from Clinical or Dental Records Health Information Abstracted from Non-Clinical Sources Health Related Data Collected through Interaction or Intervention with Participants Dental Research Involving Interaction or Intervention with Subjects Non-Health Related Data Collected through Interaction with Subjects Findings Submitted to FDA Gene Therapy/Cell Therapy Research
    Research records, including signed consent documents and case report forms 3 years from the date of the final expenditure report or the study is completed, whichever is later, per 45 CFR 75.361 No retention requirements on records that are simply duplicates of existing clinical or dental records 7 years from the date the study is completed,per HRPP Operations Manual Part 6.II.B 10 years from the date the study is completed, per Michigan Public Health Code 3 years from the date the study is completed, per HRPP Operations Manual Part 6.II.B 2 years from study Termination or submission (by sponsor or researcher) to FDA, whichever is later; per 21 CFR 58.195 Forever, until further notice
    HIPAA Waiver Documentation Included as part of the application to the IRB, stored in eResearch workspace for the study
    Record of PHI Disclosures outside the Michigan Medicine Covered Entity Submit tracking logs for disclosures to Corporate Compliance Office in accordance with Michigan Medicine Policy 01-04-335 (link requires level-2 or UMHS VPN), which shall retain the tracking information for six (6) years from the date when the information was created or was last in effect
    IRB Notice of Outcome (Approval letter; exempt or not-regulated determination) Stored in eResearch workspace for the study
    • Original determination letter available in HUM workspace, “Activities and Correspondence” heading
    • Determination letters under Ame, CR, and Adv workspace for each subsequent submission

     

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: larkspur@umich.edu
Last Updated: March 8, 2021 2:00 PM