SOCRA ICH Good Clinical Practice 2 — Questions and Answers
Question 1: According to ICH E6, what is the primary responsibility of an Independent Ethics Committee (IEC)?
- Ensure trial sites have adequate resources
- Safeguard the rights, safety, and well-being of trial subjects (Correct answer)
- Approve the study budget and financial arrangements
- Verify the sponsor's regulatory submissions
Correct 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.
Question 2: Under ICH GCP, informed consent must be obtained BEFORE which activity?
- Randomization of the subject
- Any trial-related procedures are performed (Correct answer)
- The investigator signs the protocol
- The IRB reviews the consent form
Correct answer: Any trial-related procedures are performed
ICH E6 requires that informed consent be obtained prior to any trial-related procedures, not just randomization.
Question 3: An IEC must review and approve which of the following documents before a trial begins?
- Investigator's CV only
- Protocol, informed consent form, and subject recruitment materials (Correct answer)
- Final clinical study report
- Case report form templates only
Correct 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.
Question 4: How often must a continuing IEC review occur at minimum under ICH GCP guidelines?
- Every 6 months
- Every 3 months
- At least once per year (Correct answer)
- Only when protocol amendments are submitted
Correct answer: At least once per year
ICH E6 requires that the IEC conduct continuing review of each ongoing trial at least once per year.
Question 5: Which element is NOT required to be included in an ICH GCP-compliant informed consent document?
- Description of foreseeable risks and discomforts
- Name of the sponsor's Chief Medical Officer (Correct answer)
- Statement that participation is voluntary
- Expected duration of the subject's participation
Correct 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.
Question 6: Under ICH E6, what action is required when a significant protocol amendment is made after IEC approval?
- Notify the IEC within 30 days but continue the trial
- Obtain IEC approval before implementing the amendment (Correct answer)
- Submit the amendment only to the regulatory authority
- Implement the change and notify the IEC at the next continuing review
Correct 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.
Question 7: An IEC receives a report of a serious unexpected adverse reaction in an ongoing trial. According to ICH GCP, the IEC should:
- Immediately suspend all subjects' participation
- Review the information and decide if any protective action is needed (Correct answer)
- Forward the report to the regulatory authority without review
- Request the sponsor to redesign the study protocol
Correct 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.
SOCRA ICH Good Clinical Practice 2
According to ICH E6, what is the primary responsibility of an Independent Ethics Committee (IEC)?