ACRP CCRC Exam UPDATED ACTUAL
Exam Questions and CORRECT Answers
What is ICH E6 (R2)? - CORRECT ANSWER - Guideline for Good Clinical Practice
What is ICH E2A? - CORRECT ANSWER - Clinical Safety Data Management:
Definitions and standards for expedited reporting
What is ICH E8(R1)? - CORRECT ANSWER - General considerations for clinical studies
What is ICH E9? - CORRECT ANSWER - Statistical Principles for Clinical Trials
What is ICH E11 (R1)? - CORRECT ANSWER - Clinical investigation of medicinal
products in the pediatric population
What factor is the most important to consider when deciding to proceed with a pediatric
development program for a medicinal product? - CORRECT ANSWER - The presence of
a serious or life-threatening disease for which the medicinal product represents a potentially
important advance in therapy.
When should the planning for pediatric development of a drug study begin? - CORRECT
ANSWER - In the early stages of the program, if the drug is anticipated to be utilized in
the pediatric population. Waiting until adult development has concluded can limit the opportunity
to generate meaningful data for pediatric drug development.
What is pediatric extrapolation? - CORRECT ANSWER - An approach to providing
evidence in support of effective and safe use of drugs in the pediatric population when it can be
assumed that the course of the disease and the expected response to a medicinal product would
be sufficiently similar in pediatric and reference populations (adult or other pediatric
populations)
Exam Questions and CORRECT Answers
What is ICH E6 (R2)? - CORRECT ANSWER - Guideline for Good Clinical Practice
What is ICH E2A? - CORRECT ANSWER - Clinical Safety Data Management:
Definitions and standards for expedited reporting
What is ICH E8(R1)? - CORRECT ANSWER - General considerations for clinical studies
What is ICH E9? - CORRECT ANSWER - Statistical Principles for Clinical Trials
What is ICH E11 (R1)? - CORRECT ANSWER - Clinical investigation of medicinal
products in the pediatric population
What factor is the most important to consider when deciding to proceed with a pediatric
development program for a medicinal product? - CORRECT ANSWER - The presence of
a serious or life-threatening disease for which the medicinal product represents a potentially
important advance in therapy.
When should the planning for pediatric development of a drug study begin? - CORRECT
ANSWER - In the early stages of the program, if the drug is anticipated to be utilized in
the pediatric population. Waiting until adult development has concluded can limit the opportunity
to generate meaningful data for pediatric drug development.
What is pediatric extrapolation? - CORRECT ANSWER - An approach to providing
evidence in support of effective and safe use of drugs in the pediatric population when it can be
assumed that the course of the disease and the expected response to a medicinal product would
be sufficiently similar in pediatric and reference populations (adult or other pediatric
populations)
