SOCRA ICH Good Clinical Practice 2

Question 1

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

Accepted Answer

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

Answer

Ensure trial sites have adequate resources

Answer

Approve the study budget and financial arrangements

Answer

Verify the sponsor's regulatory submissions

Question 2

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

Accepted Answer

Any trial-related procedures are performed

Answer

Randomization of the subject

Answer

The investigator signs the protocol

Answer

The IRB reviews the consent form

Question 3

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

Accepted Answer

Protocol, informed consent form, and subject recruitment materials

Answer

Investigator's CV only

Answer

Final clinical study report

Answer

Case report form templates only

Question 4

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

Accepted Answer

At least once per year

Answer

Every 6 months

Answer

Every 3 months

Answer

Only when protocol amendments are submitted

Question 5

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

Accepted Answer

Name of the sponsor's Chief Medical Officer

Answer

Description of foreseeable risks and discomforts

Answer

Statement that participation is voluntary

Answer

Expected duration of the subject's participation

Question 6

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

Accepted Answer

Obtain IEC approval before implementing the amendment

Answer

Notify the IEC within 30 days but continue the trial

Answer

Submit the amendment only to the regulatory authority

Answer

Implement the change and notify the IEC at the next continuing review

Question 7

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

Accepted Answer

Review the information and decide if any protective action is needed

Answer

Immediately suspend all subjects' participation

Answer

Forward the report to the regulatory authority without review

Answer

Request the sponsor to redesign the study protocol