Policies

Statement of Practice: Version Control of Informed Consent Document(s)

IRBMED
Aug 28, 2018 12:00 pm

To ensure that study teams are utilizing the most recently IRB-approved consent document at the time of amendment, IRBMED has standardized version control practices.

Click here for PDF version.

  • I. STATEMENT OF PRACTICE

    To assure that study teams are utilizing the most recent IRB approved consent version when making modifications at the time of amendment, IRBMED has standardized practices for version control of informed consent documents. The standardized practices, further detailed below, include procedures for: 

    • Accessing the most recent IRB approved clean version of the consent from the eResearch application in Section 10-1 (Word version) 
    • Uploading only the track changes version as part of an amendment modifying the consent 
    • Using standard naming conventions for uploading consent documents into eResearch 
  • II. Uploading Consent Documents into eResearch

    Study teams will upload the initial informed consent document for IRB review into Section 10-1 of the new study application. For subsequent amendments which modify informed consent documents, study teams will only upload a track changes version to eResearch. Study teams should not upload “clean” versions as IRBMED will label and upload the clean version to Section 10-1.

    Study teams should maintain one “stack” of documents in eResearch for each separate consent document (for studies with multiple consent documents). Each new version for a given document should be stacked on the previously uploaded final draft. Each subsequent track changes version should be stacked on the previously uploaded track changes version.

    Informed consent documents uploaded in eResearch need to follow the standard naming convention outlined below in Section IV.

    Do NOT delete any documents or stacks of documents from eResearch; these are retained for historical reference purposes.

  • III. Accessing the Most Recently Approved Consent Documents

    To modify a consent document, study teams must begin with the most recent IRB approved clean version found in Section 10-1 of the eResearch application. This is the Word version of the watermarked PDF, and is editable. Study teams must not use previous versions or documents stored outside of eResearch as those documents may not accurately reflect the final IRB approved version. 

    Study teams must continue to use the IRB approved, watermarked consent documents when consenting subjects; these are available under the “Approved Documents” tab in eResearch.

  • IV. Standard Naming Convention for Informed Consent Documents

    To maintain consistency and reduce errors, study teams must utilize the standardized naming convention for informed consent documents uploaded into the eResearch application. Study teams are required to upload a track changes version of informed consent documents into section 10-1 of the eResearch application. The title of the track changes version of the informed consent document as it appears in eResearch should be one of the following:

    • Consent-Tracked
    • Consent-Concise Subtitle-Tracked (when there are multiple consents associated with the study)
    • Assent-Tracked Parental Permission/Assent-Tracked
    • Parental Permission-Tracked

    Note: Words identified above in bold must not be changed; words identified in italics may be modified by the study team. The informed consent subtitle should be a one to two word descriptor, such as: Consent-Genetic, Consent-Screening, etc.

  • V. Finalization

    Once finalized by IRBMED, informed consent documents may not be altered without the submission and approval of an Amendment.

  • VI. References

    1. UMIC Presentation: Version Control of Informed Consent Documents
    Target: Staff File Name: SP.VersionControlInformedConsent…
    Distribution: Staff SP Number: SP.602.01
    Lead(s): J. Birk, K. Sasamoto  
    Approved By: P&G Committee Original Implementation Date: 2014.09.08
    Approval Date: 2014.10.21 Page Number: Page 3 of 3

     

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: bpsea@umich.edu
Last Updated: August 28, 2018 2:30 PM