Do Not Forget About the Process of Consent in Informed Consent Source Documentation

The Informed Consent process must be completed every time a patient is screened for a study as well as every time that there is a change to the ICF. Your site should make sure that there are adequate SOP’s outlining the site’s process for obtaining consent from patients. Source documents should also reflect the consent process as described in the SOP’s while capturing details such as what questions if any the patient had, the duration of the process, and if copy was given to the patient.