Which version of ICH E6 is referenced for 2025 exams?

Which version of ICH E6 is referenced for 2025 exams?

• A. E6 (R2) with principles aligned to E6 (R3).
• B. E6 (R1).
• C. E6 (R3).
• D. E6 (R2) and E6 (R3) combined.

Answer: (A)

The question tests your understanding of how the ICH E6 guidelines are used for exams during a transition period. For 2025 exams, the referenced standard is E6 in its R2 revision, but the exam content is aligned to the principles of E6(R3). This means you’re measured against the established requirements of R2 while also incorporating the newer ideas and expectations from R3—such as stronger emphasis on risk-based quality management and data integrity—without fully switching to R3 as the sole baseline. E6(R1) is outdated and not the reference used, and treating both R2 and R3 as completely separate standards isn’t how the exam is structured; it uses R2 as the base with alignment to R3.

The question tests your understanding of how the ICH E6 guidelines are used for exams during a transition period. For 2025 exams, the referenced standard is E6 in its R2 revision, but the exam content is aligned to the principles of E6(R3). This means you’re measured against the established requirements of R2 while also incorporating the newer ideas and expectations from R3—such as stronger emphasis on risk-based quality management and data integrity—without fully switching to R3 as the sole baseline.

E6(R1) is outdated and not the reference used, and treating both R2 and R3 as completely separate standards isn’t how the exam is structured; it uses R2 as the base with alignment to R3.