Question

The ICH E6 GCP describes standards that apply to:

A-Investigators, sponsors, and IRBs.
B- Research sponsors only
C- Investigators only
D- IRBs only

Answer 1

The ICH E6 GCP guidelines apply to Investigators, sponsors, and IRBs, who are collectively responsible for ethical and regulatory aspects of clinical trials involving human subjects.

Step-by-step explanation:

The ICH E6 GCP (Good Clinical Practice) guidelines are key standards within the field of clinical research. They outline the responsibilities and expectations for entities involved in the design, conduct, oversight, and reporting of clinical trials, especially those involving human subjects. The main parties covered by these standards are:

• Investigators, who are responsible for the conduct of the clinical trial at the trial site.
• Sponsors, who are individuals or organizations that take responsibility for the initiation, management, and/or financing of a clinical trial.
• Institutional Review Boards (IRBs), or ethics committees responsible for the initial and ongoing review of the trial's ethical aspects.

Therefore, the ICH E6 GCP describes standards that apply to Investigators, sponsors, and IRBs, which corresponds to option A. These entities work together to ensure that clinical research is conducted in adherence to ethical principles and regulatory requirements, safeguarding the rights, safety, and well-being of trial participants.