6 Key Items to Look for When Monitoring an Informed Consent Form

by | Oct 12, 2021 | Tools for Research Professionals, Clinical Research Associates, Tips for Research Professionals | 3 comments

CRAs are responsible for monitoring each Informed Consent Form (ICF) for their clinical trials. Since they involve the consent of trial participants, making sure the ICFs are completed correctly and entirely is very important. Paying attention to the details will help CRAs be successful with this task!

Here is a list of crucial items that are part of each ICF and should be reviewed by the CRA.

1. Check the Stamp of Approval

Ensure the correct version of the informed consent was used and that it has a stamp from the Institutional Review Board (IRB) or Ethics Committee (EC).

2. Review the Pagination

Review the pagination to make certain it is correct. Are all pages present? (For example: 1 of 12, 2 of 12, through 12 of 12).

3. Confirm Initials and Signatures

Confirm all required initials and/or signatures are present. This includes the participant, witness, person explaining the consent, and/or the Investigator, depending on the IRB/EC used.

4. Verify the Dates

Verify the date corresponds with the date of consent. If the dates don’t match, make sure the site included a note of clarification as documentation.

5. Double-Check the Checkboxes

Ensure any checkboxes for notifying the participant’s Primary Care Physician (PCP) or authorizing any additional sample tests are completed. If the PCP box is checked, make sure the research site has documentation of when the PCP was notified about the participant’s participation in the research study.

6. Check the Informed Consent Process

Confirm the consent process is documented in the source:

  • Was the participant given ample time to review and ask questions in a quiet setting?
  • Was the participant allowed to review with their family or physician before signing (if requested)?
  • Was the participant given a copy of their consent for their records?

We hope you found these tips to be useful. Download our PDF checklist below to use as a reference when monitoring an ICF.

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