ICH Good Clinical Practice Flashcards

According to ICH E6, what is the primary responsibility of an Independent Ethics Committee (IEC)?

Answer: Safeguard the rights, safety, and well-being of trial subjects

The IEC's primary mandate under ICH E6 is to protect the rights, safety, and well-being of trial subjects.

Under ICH GCP, informed consent must be obtained BEFORE which activity?

Answer: Any trial-related procedures are performed

ICH E6 requires that informed consent be obtained prior to any trial-related procedures, not just randomization.

An IEC must review and approve which of the following documents before a trial begins?

Answer: Protocol, informed consent form, and subject recruitment materials

ICH E6 section 3.1 requires the IEC to review the protocol, consent forms, recruitment materials, and other subject-facing documents before trial initiation.

How often must a continuing IEC review occur at minimum under ICH GCP guidelines?

Answer: At least once per year

ICH E6 requires that the IEC conduct continuing review of each ongoing trial at least once per year.

Which element is NOT required to be included in an ICH GCP-compliant informed consent document?

Answer: Name of the sponsor's Chief Medical Officer

ICH E6 lists specific required consent elements and the sponsor CMO's name is not among them; what matters is contact information for questions about rights and the trial.

Under ICH E6, what action is required when a significant protocol amendment is made after IEC approval?

Answer: Obtain IEC approval before implementing the amendment

ICH E6 section 4.10.2 requires that amendments which may affect subject safety or study conduct be approved by the IEC before implementation.

An IEC receives a report of a serious unexpected adverse reaction in an ongoing trial. According to ICH GCP, the IEC should:

Answer: Review the information and decide if any protective action is needed

The IEC must review safety information promptly and determine whether protective measures—such as protocol modification or suspension—are warranted.