According the ICH, the informed consent process should:
- Ensure that the declaration of Helsinki and the principles of GCP are adhered to
- Ensure that there is no coercion, of subjects to be on or stay on a study, at any time
- Ensure the subject’s understanding of the information they are presented by you or your designees
- Ensure that the Informed Consent document is signed and dated by the subject or subject’s legal representative.
