CLE Good Clinical Practice & ICH Guidelines 2 — Questions and Answers
Question 1: Under ICH E6(R2) GCP, which element is REQUIRED in an informed consent document for a lactation research study?
- A statement that participation is voluntary and refusal will not affect care (Correct answer)
- A guarantee that the subject will receive financial compensation
- The investigator's personal contact details for emergencies only
- A waiver of the subject's right to withdraw at any time
Correct answer: A statement that participation is voluntary and refusal will not affect care
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:
- Funding is sufficient for the research timeline
- The rights, safety, and well-being of human subjects are protected (Correct answer)
- The investigator holds a valid medical license in the state
- Publication rights are assigned to the sponsor
Correct answer: The rights, safety, and well-being of human subjects are protected
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:
- The study reaches its halfway enrollment milestone
- New information becomes available that may affect willingness to continue participation (Correct answer)
- The sponsor requests an interim analysis of the data
- A co-investigator joins the study team
Correct answer: New information becomes available that may affect willingness to continue participation
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:
- A change to the consent form wording approved by the IRB
- Any departure from the approved study protocol that was not pre-authorized (Correct answer)
- Routine updates to standard operating procedures
- A planned interim analysis requested by the data safety monitoring board
Correct answer: Any departure from the approved study protocol that was not pre-authorized
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?
- ICH Q10
- ICH S7A
- ICH E6(R2) (Correct answer)
- ICH M4
Correct answer: ICH E6(R2)
ICH E6(R2) is the GCP guideline that governs the design, conduct, recording, and reporting of clinical trials involving humans.
Question 6: Under GCP, source documents in a lactation clinical study serve to:
- Replace the requirement for electronic data capture systems
- Provide original records from which study data are derived and verified (Correct answer)
- Summarize the final study results for the sponsor
- Grant IRB approval for the next study phase
Correct answer: Provide original records from which study data are derived and verified
Source documents are the original records (e.g., medical charts, lab reports) that allow verification and reconstruction of study data.
Question 7: A lactation researcher identifies a serious adverse event (SAE) in her study. According to GCP, she must report it to the IRB and sponsor:
- Within the next annual renewal period
- Only if the SAE is directly related to the study intervention
- Promptly, within the timeframe specified in the protocol and applicable regulations (Correct answer)
- After the study is unblinded at its conclusion
Correct answer: Promptly, within the timeframe specified in the protocol and applicable regulations
GCP requires prompt SAE reporting to the IRB and sponsor within the protocol-specified and regulatory timeframes, regardless of causality certainty.
CLE Good Clinical Practice & ICH Guidelines 2
Under ICH E6(R2) GCP, which element is REQUIRED in an informed consent document for a lactation research study?