Certified Lactation Specialist Good Clinical Practice & ICH Guidelines 3

Question 1

In GCP-governed lactation studies, what is the role of the Data Safety Monitoring Board (DSMB)?

Accepted Answer

To independently review accumulating data and recommend study continuation or stopping

Answer

A DSMB independently monitors accumulating data and can recommend stopping or modifying a trial based on safety or efficacy findings.

Question 2

Which ICH E6 principle requires that clinical trials be conducted in accordance with the ethical principles of the Declaration of Helsinki?

Accepted Answer

ICH E6 Section 2.1

Answer

ICH E6 Section 2.1 states that clinical trials should be conducted in accordance with ethical principles originating from the Declaration of Helsinki.

Question 3

When a lactation study sponsor uses a Contract Research Organization (CRO), accountability for GCP compliance ultimately rests with:

Accepted Answer

The sponsor

Answer

While the CRO assumes delegated duties, the sponsor retains ultimate responsibility for GCP compliance in the trial.

Question 4

Under GCP, what must be documented when a subject withdraws consent during a lactation study?

Accepted Answer

The date, reason (if provided), and any data collected up to withdrawal

Answer

GCP requires documenting the date and reason for withdrawal, along with noting what data may still be used per the protocol.

Question 5

ICH E3 provides guidelines for the structure and content of which clinical trial document?

Accepted Answer

Clinical Study Report

Answer

ICH E3 provides detailed guidance on the structure and content of clinical study reports submitted to regulatory authorities.

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Good Clinical Practice & ICH Guidelines 3