SOCRA CCRP Informed Consent 2

Question 1

Under ICH-GCP, which of the following must be included in the informed consent form?

Accepted Answer

A statement that participation is voluntary and that the subject may withdraw at any time without penalty

Answer

ICH-GCP Section 4.8.10 requires that the informed consent form include a statement that participation is voluntary and that the subject may refuse to participate or withdraw at any time without penalty or loss of benefits.

Question 2

What must occur before any trial-related procedures are performed on a potential study subject?

Accepted Answer

Written informed consent must be obtained

Answer

ICH-GCP requires that freely given written informed consent must be obtained from each subject before any trial-specific procedures are performed, including screening tests.

Question 3

How should the informed consent process be handled for a subject who cannot read?

Accepted Answer

An impartial witness must be present during the entire consent discussion and must sign the consent form

Answer

When a subject cannot read, ICH-GCP requires that an impartial witness be present during the entire informed consent discussion. The witness must sign and date the consent form to attest that the information was accurately explained and apparently understood.

Question 4

When a significant new finding arises during a clinical trial that could affect a subject's willingness to continue, what action is required?

Accepted Answer

The subject must be informed promptly and re-consent must be obtained with a revised consent form

Answer

ICH-GCP Section 4.8.2 requires that when new information becomes available that may be relevant to the subject's willingness to continue, the subject must be informed in a timely manner and a revised consent form must be signed.

Question 5

What is the role of a legally acceptable representative (LAR) in the informed consent process?

Accepted Answer

To provide informed consent on behalf of a subject who is unable to provide consent themselves

Answer

A legally acceptable representative may provide informed consent on behalf of a subject who is unable to do so (e.g., due to incapacity, age), according to applicable laws and regulations.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Informed Consent 2