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Consent Signing Checklist

What this page tells you

Checklist to run through before and during consent signing: correct ICF version, adequate review time, understanding check, verbal review of key elements, eligibility, required documents, private setting, complete signatures and dates, consent note, and upload per SOP.

▢ Confirm Correct Consent Version

  • ▢ Latest IRB‑approved version
  • ▢ Correct study title, PI, version number, version date

  • ▢ Correct consent type (7T, 3T, Pioneer, Collaborative, etc.)
    ▢ Ensure Participant Had Adequate Review Time

  • ▢ Provided consent form in advance (if applicable)

  • ▢ Participant had time to read without pressure

  • ▢ Participant had opportunity to ask questions
    ▢ Verify Participant Understanding (Use Open‑Ended Questions)

  • ▢ Participant can explain study purpose

  • ▢ Participant can describe procedures
  • ▢ Participant can identify risks

  • ▢ Participant understands voluntary nature and alternatives
    ▢ Review Key Elements Verbally

  • ▢ Purpose

  • ▢ Procedures
  • ▢ Risks & discomforts
  • ▢ Benefits
  • ▢ Confidentiality
  • ▢ Voluntary participation + right to withdraw
  • ▢ Compensation & costs

  • ▢ Contact information
    ▢ Confirm Eligibility to Consent

  • ▢ Participant is 18+ (unless assent/parental permission applies)

  • ▢ Participant is capable of informed decision‑making
  • ▢ No signs of coercion or impaired judgment

  • ▢ LAR documentation verified (if applicable)
    ▢ Provide All Required Documents

  • ▢ Full consent form

  • ▢ HIPAA authorization (if PHI collected)
  • ▢ Supplemental study‑specific documents

  • ▢ Copy for participant to keep
    ▢ Prepare the Signing Environment

  • ▢ Private, unrushed setting

  • ▢ Pen or electronic signature device ready

  • ▢ Participant reminded they can stop at any time
    ▢ Complete Signature Section Correctly

  • ▢ Participant signature + date

  • ▢ Person obtaining consent signature + date
  • ▢ Witness signature (if required)

  • ▢ All dates match and are legible
    ▢ Document the Consent Encounter >> use this guide >> All Consent Notes (Consent Note Templates)

  • ▢ Date/time consent obtained

  • ▢ Who obtained consent
  • ▢ Questions asked + clarifications provided

  • ▢ Participant received a copy
    ▢ Store and Upload According to SOPs

  • ▢ Upload signed consent to correct secure folder

  • ▢ Use required naming conventions
  • ▢ Maintain version control
  • ▢ Confirm HIPAA‑compliant storage