ICH E6(R2)- Interpretation and Application ACTUAL QUESTIONS AND CORRECT ANSWERS

ICH E6(R2)- Interpretation and
Application ACTUAL QUESTIONS AND
CORRECT ANSWERS
ICH stands for - CORRECT ANSWERS✅✅International Council for Harmonisation



Regulatory Reviewers focus on - CORRECT ANSWERS✅✅Focus on study validity and
results- want to see GCP used to produce high quality data based on the protocol


Inspectors focus on - CORRECT ANSWERS✅✅Focus on study conduct and oversight


True or False. ICH brings regulatory authorities and the pharmaceutical industry together to
discuss scientific and technical aspects of drug registration - CORRECT
ANSWERS✅✅True



What is the mission of ICH? - CORRECT ANSWERS✅✅To achieve greater harmonisation
worldwide


ICH Guidelines. QESM - CORRECT ANSWERS✅✅Quality, Efficacy, Safety,
Multidisciplinary


An international ethical and quality standard for designing, conducting, recording and
reporting of trials that involve the participation of human subjects - CORRECT
ANSWERS✅✅ICH E6(R2) GCP


All of the following are reasons to follow ICH E6(R2) Except
A. Unified standard
B Public assurance
C. Relevant for all studies

D. Reduce lawsuits - CORRECT ANSWERS✅✅D


Reasons for ICH E6(R1) revision to ICH E6(R2) include all the following except

, A. Increased globalization
B. Increased study complexity
C. Increased technological capabilities

D. Increased lawsuits - CORRECT ANSWERS✅✅D


Which concept was introduced in ICH E6(R2)?
A. Quality
B. Oversight
C. Security

D. None of the above - CORRECT ANSWERS✅✅B


Introduced bridging studies and intrinsic and extrinsic ethnic factors - CORRECT
ANSWERS✅✅ICH E5 Acceptance of Foreign Data


Introduced the multi-regional clinical trial (MRCT) concept to serve a bridging purpose -
CORRECT ANSWERS✅✅ICH E5 Questions and Answers


Addresses the need for critical protocol design and a structured statistical framework -
CORRECT ANSWERS✅✅ICH E9 Statistical Principles for Clinical Trials


Describes principles for the planning/ design of MRCTs, aiming to increase MRCT
acceptability in global regulatory submissions - CORRECT ANSWERS✅✅ICH E17:
General Principles for Planning and Design of Multi-Regional Clinical Trials (MRCTs)


ICH E6 (R2) can be used as a guideline for inspectors to focus on which of the following?
A. Protection and reliability of trial results
B. Quality of data
C. Assurance of the protection of human research participants

D. All of the above - CORRECT ANSWERS✅✅D



The goals of GCP include - CORRECT ANSWERS✅✅Ensuring the rights, safety, and well-
being of participants