CTA Good Clinical Practice & ICH Guidelines 2 — Questions and Answers
Question 1: Under ICH E6(R2), which party is ultimately responsible for the overall conduct, integrity, and reporting of a clinical trial?
- The Principal Investigator
- The Sponsor (Correct answer)
- The IRB/IEC
- The CRO
Correct answer: The Sponsor
The sponsor bears ultimate responsibility for the trial's overall conduct, integrity, and reporting, even when a CRO is delegated tasks.
Question 2: What is the minimum retention period for essential documents specified in ICH E6(R2) after study completion when no local regulation specifies otherwise?
- 2 years (Correct answer)
- 5 years
- 15 years
- 10 years
Correct answer: 2 years
ICH E6(R2) specifies that essential documents must be retained for at least 2 years after the last marketing approval or after study discontinuation.
Question 3: Which ICH E6(R2) principle states that each individual involved in conducting a trial should be qualified by education, training, and experience?
- Principle 2
- Principle 4 (Correct answer)
- Principle 8
- Principle 11
Correct answer: Principle 4
ICH E6(R2) Principle 4 requires that each individual be qualified for their trial role by appropriate education, training, and experience.
Question 4: In GCP, what distinguishes a 'serious adverse event' (SAE) from an 'adverse event' (AE)?
- SAEs require lab confirmation; AEs do not
- SAEs result in significant medical outcomes such as death or hospitalization; AEs may not (Correct answer)
- SAEs occur only during the treatment phase; AEs can occur post-trial
- SAEs must be reported by the subject; AEs are reported by the investigator
Correct answer: SAEs result in significant medical outcomes such as death or hospitalization; AEs may not
An SAE meets at least one serious criterion (death, life-threatening, hospitalization, disability, congenital anomaly, or medically important event), whereas an AE is any untoward occurrence that may not meet these criteria.
Question 5: Under ICH E6(R2), a sponsor's audit of a clinical trial site is best described as:
- A regulatory inspection conducted by a health authority
- A systematic and independent examination of trial-related activities and documents by the sponsor (Correct answer)
- A routine site visit by the CRA to verify data entry
- An IRB review of the protocol and consent forms
Correct answer: A systematic and independent examination of trial-related activities and documents by the sponsor
An audit is a sponsor-conducted, independent examination to evaluate whether trial activities and data comply with the protocol, SOPs, GCP, and applicable regulations.
Question 6: Which section of the ICH E6(R2) guideline specifically addresses the content and maintenance of the Investigator's Site File (ISF)?
- Section 4 — Investigator
- Section 6 — Clinical Trial Protocol
- Section 8 — Essential Documents (Correct answer)
- Section 5 — Sponsor
Correct answer: Section 8 — Essential Documents
Section 8 of ICH E6(R2) covers essential documents, cataloguing what must be maintained in both the investigator's and sponsor's trial master files.
Question 7: When a sponsor transfers trial-related duties to a CRO, ICH E6(R2) requires that:
- The CRO assumes all sponsor regulatory obligations
- A written agreement clearly specifying transferred duties is established (Correct answer)
- The IRB must approve the CRO appointment
- The investigator countersigns the CRO contract
Correct answer: A written agreement clearly specifying transferred duties is established
ICH E6(R2) requires a written agreement between the sponsor and CRO that defines which sponsor duties are delegated; the sponsor retains ultimate accountability.
CTA Good Clinical Practice & ICH Guidelines 2
Under ICH E6(R2), which party is ultimately responsible for the overall conduct, integrity, and reporting of a clinical trial?