This is a ready-to-use SOP for the informed consent process at a clinical trial site. Informed consent is where ethics becomes operational, and consent findings are consistently among the most frequent and most serious in GCP inspections, so this procedure is worth getting exactly right. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows the template. Verify each cited regulation against the current source before you rely on it. This is educational reference content, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Document title | Informed Consent Process for Clinical Trials |
| Document number | <<FILL: e.g. SOP-CLIN-008>> |
| Version | <<FILL: e.g. 1.0>> |
| Effective date | <<FILL: YYYY-MM-DD>> |
| Supersedes | <<FILL: prior doc/version or "New">> |
| Process owner | <<FILL: e.g. Clinical Operations / Site QA>> |
| Applies to | <<FILL: sites / studies in scope>> |
1. Purpose
Define how informed consent is obtained and documented so that each participant voluntarily confirms willingness to take part after being informed of all aspects of the trial relevant to that decision, and so that the consent record withstands monitoring, audit, and inspection.
2. Scope
Applies to consent of all participants (or their legally acceptable representatives) in interventional clinical trials at the sites in scope, including screening consent, re-consent on amendment, consent of participants who cannot read, and, where applicable, consent of vulnerable populations under the additional safeguards the protocol and ethics committee require. Governed by ICH E6 section 4.8 and applicable national requirements (for example 21 CFR Part 50 in the United States).
3. Responsibilities
| Role | Responsibility |
|---|---|
| Principal investigator | Accountable for the consent of every participant; ensures only delegated, trained staff take consent |
| Delegated consenting staff | Conduct the consent discussion and obtain and document consent per this SOP |
| Study coordinator | Maintains the current approved ICF version, the delegation log, and the consent records |
| Impartial witness | Present for the full discussion and signs where a participant cannot read |
| Sponsor / CRO monitor | Verifies consent during monitoring; escalates findings |
| Site QA | Periodic review of consent records; supports inspection |
4. Definitions
- Informed consent form (ICF): the written document that records the information given and the participant’s signed, dated agreement.
- Legally acceptable representative (LAR): an individual authorised under applicable law to consent on behalf of a prospective participant.
- Re-consent: obtaining consent again on a new approved ICF version that bears on continued participation.
- Study-specific procedure: any procedure, including screening, performed only because of the trial.
5. Procedure
5.1 Before consent
- Confirm the ICF version in hand is the current IRB/IEC-approved version and is effective on the consent date. Do not use a draft or a superseded version. Keep a version log of every approved ICF with effective dates.
- Confirm the person taking consent is listed for that task on the delegation log and is trained on the protocol and this SOP.
5.2 The consent discussion
- Give the participant (or LAR) adequate time and opportunity to read the ICF and ask questions, in language they understand, with no coercion or undue influence.
- Cover the elements required by ICH E6 section 4.8.10: that this is research and why; the treatments and the chance of assignment to each; procedures and what is expected of the participant; foreseeable risks and reasonably expected benefits (stating frankly where the participant gains none); alternatives; compensation and treatment for trial-related injury; that participation is voluntary and can be withdrawn at any time without penalty; that monitors, auditors, the ethics committee, and regulators may review records while preserving confidentiality; that new information affecting willingness will be shared; whom to contact; foreseeable circumstances ending participation; duration; and the approximate number of participants. Describe these elements in your own words; do not paste guideline text into the ICF beyond what your approved form requires.
5.3 Signing
- The participant (or LAR) personally signs and dates the ICF BEFORE any study-specific procedure, including screening procedures that exist only for the trial.
- The person conducting the consent discussion also personally signs and dates.
- Where the participant cannot read, an impartial witness is present for the entire discussion and signs and dates, attesting the information was accurately explained and consent was freely given.
5.4 After signing
- Give the participant a copy of the signed ICF and of any later amended versions they sign.
- File the signed original per the study filing plan (Investigator Site File), and record the consent in the source (for example the participant’s chart) with the ICF version and date.
5.5 Re-consent
- When a new ICF version is approved that bears on continued participation (a safety-relevant amendment, a new risk, a change in procedures), re-consent affected active participants on the new version and document it. Record the reason and the date.
6. Acceptance criteria
- The consent date is on or before the first study-specific procedure for every participant.
- The signed ICF version matches an IRB/IEC-approved version effective on that date.
- Participant (or LAR) and consenting-staff signatures and dates are present; a witness signature is present where required.
- Re-consent is documented whenever a new relevant version was approved during participation.
- Only delegated, trained staff obtained consent.
7. Records generated
Signed ICFs; ICF version log; the consent note in source; the delegation log; re-consent records; monitoring and QA review records of consent.
8. References
- ICH E6 Good Clinical Practice, section 4.8 (informed consent of trial subjects); E6(R3) Annex 1 for the reorganised requirements (describe in your own words; brief attributed quotation only)
- Declaration of Helsinki (ethical basis)
- 21 CFR Part 50 (protection of human subjects), where the trial is under US jurisdiction
- Applicable national and regional consent requirements
9. Revision history
| Version | Date | Description | Author |
|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: e.g. Initial issue>> | <<FILL>> |
10. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer (Clinical / medical) | <<FILL>> | ||
| Approver (QA) | <<FILL>> |
Filled specimen
A worked example of one participant’s consent, values invented.
Study: Protocol ABC-301, a randomised interventional trial. ICF version 3.0, IRB-approved effective 2026-05-15.
Event: Participant 3012 attends screening on 2026-06-02. Coordinator confirms ICF v3.0 is current and effective; confirms she (the coordinator) is on the delegation log for consent and is trained. She reviews the form with the participant, answers questions about randomisation odds and the washout, and confirms no coercion. The participant signs and dates 2026-06-02 at 09:20; the coordinator signs and dates the same. No study-specific procedure (including the screening ECG and labs drawn only for the trial) was performed before 09:20. The participant receives a copy; the original is filed in the ISF and the consent is noted in the chart with “ICF v3.0 signed 2026-06-02.”
Re-consent: On 2026-08-10 the IRB approves ICF v4.0 adding a newly identified risk. Participant 3012 is active, so she is re-consented on v4.0 at her next visit 2026-08-18; the re-consent and reason are documented.
What this prevents: the most common consent findings, a superseded version signed, a screening procedure before the consent date, a missing signature or date, consent by undelegated staff, or no re-consent after a safety amendment, are each blocked by a step above.