This is a ready-to-use checklist for verifying one participant’s informed consent, for use by a monitor during source data verification, by site QA during a consent review, or during inspection preparation. Score each item Pass, Fail, or NA, and convert every Fail into a tracked action with an owner and a date. Replace every <<FILL: ...>> placeholder with your specifics. A filled specimen follows. Verify cited regulations against the current source. This is general guidance to adapt, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Study / protocol | <<FILL>> |
| Site | <<FILL>> |
| Participant ID | <<FILL>> |
| Reviewer | <<FILL: name, role>> |
| Review date | <<FILL: YYYY-MM-DD>> |
| ICF version(s) reviewed | <<FILL>> |
1. Version and approval
| # | Item | Reference | Result |
|---|---|---|---|
| 1.1 | The ICF version signed was an IRB/IEC-approved version | E6 4.8 | Pass / Fail / NA |
| 1.2 | That version was effective (approved and not superseded) on the consent date | E6 4.8 | Pass / Fail / NA |
2. Timing
| # | Item | Reference | Result |
|---|---|---|---|
| 2.1 | Consent date is on or before the first study-specific procedure | E6 4.8 | Pass / Fail / NA |
| 2.2 | No screening procedure done only for the trial preceded the consent date/time | E6 4.8 | Pass / Fail / NA |
3. Signatures and dates
| # | Item | Reference | Result |
|---|---|---|---|
| 3.1 | Participant (or LAR) signature present | E6 4.8 | Pass / Fail / NA |
| 3.2 | Participant (or LAR) date present and personally entered | E6 4.8 | Pass / Fail / NA |
| 3.3 | Consenting-staff signature and date present | E6 4.8 | Pass / Fail / NA |
| 3.4 | Where LAR consented, the basis is documented and permitted | E6 4.8 | Pass / Fail / NA |
4. Delegation and conduct
| # | Item | Reference | Result |
|---|---|---|---|
| 4.1 | Consenting person is on the delegation log for consent | E6 4 | Pass / Fail / NA |
| 4.2 | Consenting person was trained on the protocol and consent SOP | E6 4 | Pass / Fail / NA |
| 4.3 | Where the participant could not read, an impartial witness was present and signed | E6 4.8 | Pass / Fail / NA |
5. Copy and source
| # | Item | Reference | Result |
|---|---|---|---|
| 5.1 | Participant received a copy of the signed ICF | E6 4.8 | Pass / Fail / NA |
| 5.2 | Consent is recorded in source (chart) with ICF version and date | E6 4.9 | Pass / Fail / NA |
6. Re-consent
| # | Item | Reference | Result |
|---|---|---|---|
| 6.1 | Every approved version relevant during participation was re-consented | E6 4.8 | Pass / Fail / NA |
| 6.2 | Re-consent reason and date are documented | E6 4.8 | Pass / Fail / NA |
Findings and actions
| Item | Finding | Action | Owner | Due | Status |
|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Open/Closed |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Reviewer | <<FILL>> | ||
| Site QA / PI (as applicable) | <<FILL>> |
Filled specimen
Illustrative, values invented.
| Field | Entry |
|---|---|
| Study / protocol | ABC-301 |
| Site | Site 04 |
| Participant ID | 3012 |
| Reviewer | J. Okafor, CRA |
| Review date | 2026-08-20 |
| ICF version(s) reviewed | v3.0 (initial), v4.0 (re-consent) |
Results: 1.1 Pass; 1.2 Pass; 2.1 Pass (consent 2026-06-02, first trial procedure same day after signing); 2.2 Pass (screening ECG time-stamped after consent time); 3.1 to 3.3 Pass; 3.4 NA (no LAR); 4.1 Pass; 4.2 Pass; 4.3 NA (participant able to read); 5.1 Pass; 5.2 Pass; 6.1 Pass (v4.0 re-consent on 2026-08-18); 6.2 Pass.
One Fail example on a different participant to show the action loop: item 2.2 Fail, a haematology panel drawn 40 minutes before the consent time-stamp. Action: document as a protocol deviation, assess the participant’s data and safety, retrain the coordinator on consent-before-procedure timing, and confirm no other participant affected. Owner: PI. Due: 2026-08-27. Status: Open.