Certified Lactation Specialist Good Clinical Practice & ICH Guidelines 2

Question 1

Under ICH E6(R2), what is the primary purpose of source data verification (SDV)?

Accepted Answer

To confirm case report form data accurately reflects source documents

Answer

SDV ensures data recorded in the CRF is consistent with the original source documents, maintaining data integrity.

Question 2

According to GCP, when must an investigator obtain informed consent?

Accepted Answer

Before any study-specific procedures are performed

Answer

GCP requires informed consent to be obtained prior to any study-related procedure, including screening tests.

Question 3

Which ICH guideline specifically addresses stability testing of new drug substances and products?

Accepted Answer

ICH Q1A(R2)

Answer

ICH Q1A(R2) provides guidance on the stability testing requirements for registration of new drug substances and products.

Question 4

In a lactation research study following GCP, what constitutes a 'protocol deviation'?

Accepted Answer

Any departure from the approved protocol procedures

Answer

A protocol deviation is any unplanned departure from the study procedures outlined in the approved protocol.

Question 5

Under ICH E6 GCP, who holds ultimate responsibility for the overall conduct of a clinical trial at a site?

Accepted Answer

The principal investigator

Answer

The principal investigator is ultimately responsible for the conduct of the clinical trial at the investigational site.

Certified Lactation Specialist Practice Test