Question

If following ICH guidelines who all should sign the consent form between the subject, witness, and person obtaining consent.

A Every ICF should be signed by the participant and the investigator and dated at real time.
B A copy of the signed ICF is retained by the investigator and another copy is given to the participant.
C The investigator or a person knowledgeable about the trial and designated by the investigator should obtain informed consent.
D All of these

Answer 1

The ICF must be signed by the participant, the investigator, or a designated knowledgeable person, and be dated in real time. Copies of the signed ICF are kept by both the investigator and the participant.

Step-by-step explanation:

According to ICH guidelines, informed consent forms (ICFs) are essential documents in clinical research and their completion is a critical step in protecting the rights and welfare of participants. The question asks which individuals should sign an ICF in compliance with these guidelines. The correct response would be:

D. All of these

A. Every ICF should be signed by the participant and the investigator and dated at real time. B. A copy of the signed ICF is retained by the investigator and another copy is given to the participant. C. The investigator or a person knowledgeable about the trial and designated by the investigator should obtain informed consent. These points ensure that participants are appropriately informed about the study they are participating in, that they have given their consent freely, and that there is documentation evidencing this process.