Obtain ICH GCP informed consent

Practice the sequence you already learned for “Obtain ICH GCP informed consent” until the order feels automatic. Drill the ICH E6 informed-consent order from clinical-research training. Study procedures are not started before the signed consent is filed.

1. Confirm the current IRB-approved consent version.
2. Give the participant adequate time and a private setting.
3. Explain the study, risks, alternatives, and the right to withdraw.
4. Answer questions and assess understanding.
5. Obtain signatures and dates from the participant and the person obtaining consent.
6. Provide a copy to the participant.
7. File the original before any study procedure.