1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.
VERSION CONTROL OF INFORMED CONSENT DOCUMENTS Developed by: U-MIC University of Michigan IRB Collaborative
Version control of informed consent documents 3 Developed by: U-MIC standardized version control practices to ensure that study teams amending consent documents utilize the most recent IRB-approved version accessing most recent IRB-approved clean MS-Word version from Section 10-1 of eResearch uploading only the track-changes version with amendment using standardized naming conventions when uploading documents
Version control of informed consent documents 4 Developed by: U-MIC Uploading documents New Study application upload initial informed consent document to Section 10-1 Amendment applications upload only track-changes version IRBMED staff will label and upload clean version.
Version control of informed consent documents 5 Developed by: U-MIC Maintaining documents Maintain one stack of documents in eResearch for each separate consent document. Stack each new version on the previously uploaded final draft. Stack each subsequent track-changes version on the previously uploaded track-changes version.
Version control of informed consent documents 6 Developed by: U-MIC Modifying documents Begin with most recent IRB-approved clean version in Section MS-Word version of watermarked PDF editable Do not use previous versions documents stored outside of eResearch
Version control of informed consent documents 7 Developed by: U-MIC Naming documents Use standardized naming convention when uploading informed consent documents. Name track-changes version one of the following: 1. Consent-Track 2. Consent- Concise Subtitle -Track (multiple consents in the study) 3. Assent-Track 4. Parental Permission/Assent-Track 5.Parental Permission-Track Boldface: Do not alter. Italics: Replace with short descriptor. Consent-Genetic Consent-Screening
Version control of informed consent documents 8 Developed by: U-MIC Do not alter finalized informed consent documents without the submission and approval of an Amendment. To consent participants, use the watermarked, PDF version of the consent document uploaded by IRBMED staff.
9 Developed by: U-MIC Version control of informed consent documents Version control of informed consent documents
THANK YOU. Kate Sasamoto S. Joseph Austin Judy Birk IRBMED 10 Developed by: U-MIC