CLE Good Clinical Practice & ICH Guidelines 2

Question 1

Under ICH E6(R2) GCP, which element is REQUIRED in an informed consent document for a lactation research study?

Accepted Answer

A statement that participation is voluntary and refusal will not affect care

Answer

ICH E6(R2) mandates that informed consent must include a statement that participation is voluntary and that declining or withdrawing will not penalize care.

Question 2

According to GCP principles, an Institutional Review Board (IRB) must review a breastfeeding study protocol primarily to ensure:

Accepted Answer

The rights, safety, and well-being of human subjects are protected

Answer

The primary mandate of an IRB under GCP is to protect the rights, safety, and well-being of human research subjects.

Question 3

A lactation educator conducting a clinical study must obtain a new or updated informed consent when:

Accepted Answer

New information becomes available that may affect willingness to continue participation

Answer

GCP requires re-consent whenever new information emerges that could materially affect a subject's willingness to remain in a study.

Question 4

In GCP-compliant lactation research, the term 'protocol deviation' refers to:

Accepted Answer

Any departure from the approved study protocol that was not pre-authorized

Answer

A protocol deviation is an unplanned, non-pre-authorized departure from the approved study protocol procedures.

Question 5

Which ICH guideline specifically addresses the conduct of Good Clinical Practice for human clinical trials?

Accepted Answer

ICH E6(R2)

Answer

ICH E6(R2) is the GCP guideline that governs the design, conduct, recording, and reporting of clinical trials involving humans.

(CLE) Certified Lactation Educator Practice Test

(CLE) Certified Lactation Educator Practice Test

CLE Good Clinical Practice & ICH Guidelines 2