Run Informed Consent Completeness Audit — Free

Audit Setup

Consent form matches the intended procedure and patient critical (required)

Verify the document identifies the correct patient and the planned procedure or intervention.

Yes No N/A

Consent form version, date, and facility are present

Check that the form includes a version/date identifier and the correct facility or service location.

Yes No N/A

Interpreter or communication accommodation documented when applicable

If language, hearing, or communication support was needed, confirm the accommodation is documented.

Yes No N/A

Patient capacity or legal representative authority documented when applicable critical (required)

If the patient did not sign for themselves, verify the legal representative relationship or authority is documented.

Yes No N/A

Disclosure of Procedure and Material Risks

Procedure or treatment is clearly described critical (required)

The form should state what procedure, treatment, or intervention the patient is agreeing to.

Yes No N/A

Material risks and complications are documented critical (required)

Confirm the form discloses meaningful risks, complications, and adverse outcomes relevant to the procedure.

Yes No N/A

Expected benefits or goals are documented

Verify the form explains the intended benefit, goal, or purpose of the procedure.

Yes No N/A

Material limitations or possibility of no benefit are documented

Check whether the form notes that the procedure may not achieve the intended result or may require additional treatment.

Yes No N/A

Alternatives and Refusal Information

Reasonable alternatives are listed critical (required)

Verify the form identifies reasonable alternatives, including non-procedural or less invasive options when applicable.

Yes No N/A

Risks and benefits of alternatives are summarized

Check that the form provides enough detail for the patient to compare the proposed procedure with alternatives.

Yes No N/A

Patient refusal or deferral option is documented

Confirm the form or record shows the patient could refuse or postpone the procedure.

Yes No N/A

Questions were answered or opportunity to ask questions documented

Verify the record reflects that the patient had an opportunity to ask questions before signing.

Yes No N/A

Authentication and Witnessing

Patient or legal representative signature is present critical (required)

The consent must be signed by the patient or an authorized legal representative.

Yes No N/A

Signature date and time are present critical (required)

Confirm the consent was signed and dated before the procedure, with time documented when required.

Yes No N/A

Witness signature is present when required by policy or law

If the organization or procedure requires a witness, verify the witness signature is included and legible.

Yes No N/A

Signing clinician or provider attestation is present when required

Check whether the provider who obtained consent signed or attested as required by local policy.

Yes No N/A

All signatures are legible and attributable

Verify names, roles, and signatures can be read and matched to the correct individuals.

Yes No N/A

Exceptions, Deficiencies, and Closeout

Any missing consent element is documented as a deficiency critical (required)

Record any omission, ambiguity, or incomplete element that prevents the consent from being considered complete.

Yes No N/A

Corrective action taken before procedure is documented critical (required)

If a deficiency was found, document whether the form was corrected, re-signed, or the procedure was delayed.

Yes No N/A

Reference to applicable policy or SOP

Enter the policy, SOP, or consent standard used for this audit.

Inspector final disposition

Select the final audit outcome after reviewing all required elements.

Get your results

Enter your email — we'll send you a PDF of your filled-out template, plus the occasional MangoScoop newsletter (templates, workflow tips, product updates). Unsubscribe anytime — link is in every email.

Email (required)

Your name (optional)

Run: Informed Consent Completeness Audit

Audit Setup

Disclosure of Procedure and Material Risks

Alternatives and Refusal Information

Authentication and Witnessing

Exceptions, Deficiencies, and Closeout

Get your results