During a monitoring visit or audit, review the procedure for reconsenting, either for minors or generally. Check the internal audits of this procedure for the results; and check the CAPA log to see if a deviation was created. Good luck!
------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
------------------------------
Original Message:
Sent: 10-Feb-2022 04:50
From: Anonymous Member
Subject: Consent in pediatric trials when subjects reach age of consent
This message was posted by a user wishing to remain anonymous
With the recent implementation of the Clinical Trial Regulation can I ask how people are dealing with the following Article for pediatric studies where subjects reach the age of consent during the trial.
Article 32(3) of the EU Clinical Trial Regulation states - If during a clinical trial the minor reaches the age of legal competence to give informed consent as defined in the law of the Member State concerned, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical trial.
Given that full date of birth is usually not collected or visible to sponsors or CROs, how can this be monitored and what happens if a study includes daily dosing, does the patient have to stop taking the IMP on their birthday if they haven't received and signed a consent form to replace the assent they had previously signed?