Certified Lactation Specialist Good Clinical Practice & ICH Guidelines 2 — Questions and Answers
Question 1: Under ICH E6(R2), what is the primary purpose of source data verification (SDV)?
- To confirm case report form data accurately reflects source documents (Correct answer)
- To audit the sponsor's financial records
- To verify that study drugs were manufactured correctly
- To assess investigator qualifications
Correct answer: To confirm case report form data accurately reflects source documents
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?
- After the first dose of study medication
- Before any study-specific procedures are performed (Correct answer)
- At the time of the first follow-up visit
- Only if the subject requests it
Correct answer: Before any study-specific procedures are performed
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?
- ICH E6
- ICH S7A
- ICH Q1A(R2) (Correct answer)
- ICH E2A
Correct answer: ICH Q1A(R2)
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'?
- Any departure from the approved protocol procedures (Correct answer)
- A change in study personnel
- An adverse event unrelated to the study drug
- The use of a new data collection tool
Correct answer: Any departure from the approved protocol procedures
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?
- The clinical research coordinator
- The sponsor's monitor
- The principal investigator (Correct answer)
- The IRB/IEC chairperson
Correct answer: The principal investigator
The principal investigator is ultimately responsible for the conduct of the clinical trial at the investigational site.
Question 6: Which of the following best describes 'blinding' in the context of GCP and lactation research?
- Redacting participant names from all documents
- Preventing one or more parties from knowing treatment assignment (Correct answer)
- Encrypting electronic data systems
- Hiding adverse event data from sponsors
Correct answer: Preventing one or more parties from knowing treatment assignment
Blinding is a procedure in which one or more parties are unaware of the treatment assignment to reduce bias.
Question 7: According to GCP principles, how long must essential documents be retained after trial completion?
- 1 year
- 2 years minimum, or as required by regulations (Correct answer)
- 6 months
- Indefinitely without exception
Correct answer: 2 years minimum, or as required by regulations
GCP requires essential documents to be retained for at least 2 years after the last marketing approval, or longer per applicable regulations.
Certified Lactation Specialist Good Clinical Practice & ICH Guidelines 2
Under ICH E6(R2), what is the primary purpose of source data verification (SDV)?