SOCRA CCRP Informed Consent 3

Question 1

What is the minimum time a subject should be given to consider participating in a clinical trial before signing the informed consent?

Accepted Answer

There is no specific minimum time, but the subject must have sufficient time to consider participation

Answer

ICH-GCP does not specify a minimum waiting period but requires that the subject be given sufficient time and opportunity to inquire about details of the trial and to decide whether to participate.

Question 2

In an emergency situation where a subject cannot give consent and no LAR is available, what does ICH-GCP recommend?

Accepted Answer

The subject may be enrolled if the protocol has IRB/IEC-approved provisions for emergency consent exception

Answer

ICH-GCP Section 4.8.15 allows enrollment without prior consent in emergency situations if the protocol and IRB/IEC-approved procedures provide for such exceptions, and consent is obtained as soon as possible.

Question 3

What is the investigator's responsibility regarding subjects who withdraw their consent during a clinical trial?

Accepted Answer

Respect the withdrawal, discontinue trial procedures, and offer the option to allow use of already-collected data

Answer

When a subject withdraws consent, the investigator must respect the decision, stop trial procedures, and may ask whether the subject agrees to allow continued use of data already collected, but cannot compel it.

Question 4

Which element is NOT typically required in an informed consent form according to ICH-GCP?

Accepted Answer

The total number of sites participating in the trial

Answer

While the informed consent must include risks, alternative treatments, and injury compensation information, the total number of trial sites is not a required element under ICH-GCP Section 4.8.10.

Question 5

What documentation is required when a subject provides oral consent but is physically unable to sign the written consent form?

Accepted Answer

An impartial witness must attest to the subject's oral consent by signing and dating the form

Answer

When a subject can understand and consent verbally but cannot physically sign, an impartial witness must be present, verify the subject's oral consent, and sign and date the form on the subject's behalf.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Informed Consent 3