,ACRP CCRC Exam Prep 2026 | 138 Practice Questions with Answers & Explanations
EXAM OVERVIEW
The ACRP Certified Clinical Research Coordinator (CCRC®) exam validates expertise in
managing clinical trials. The exam content is organized into six key domains based on the ACRP
Examination Content Outline (ECO):
Domain Percentage
Ethical and Participant Safety Considerations 19%
Clinical Trial Operations (GCPs) 23%
Study and Site Management 22%
Product Development and Regulation 13%
Data Management and Informatics 13%
Scientific Concepts and Research Design 8%
DOMAIN 1: SCIENTIFIC CONCEPTS AND RESEARCH DESIGN (Questions 1-12)
Question 1
A clinical trial is designed to compare a new investigational drug against a placebo. Neither the
participants nor the study staff know which treatment is being administered. What type of
study design is this?
A) Open-label
B) Single-blind
,C) Double-blind
D) Crossover
Answer: C) Double-blind
Rationale: In a double-blind study, neither the participants nor the study staff know the
treatment assignments. This minimizes bias in both participant reporting and investigator
assessment. Single-blind (B) means only one party is blinded. Open-label (A) means everyone
knows the treatment. A crossover design (D) involves participants receiving both treatments at
different times.
Question 2
A sponsor company is preparing an Investigational Brochure for a new drug. Which of the
following is a required element?
A) The drug's retail price
B) A summary of nonclinical and clinical data relevant to human safety
C) The marketing strategy for the drug
D) The names of all investigators who will use the drug
Answer: B) A summary of nonclinical and clinical data relevant to human safety
Rationale: The Investigational Brochure (IB) is a critical document that summarizes the physical,
chemical, pharmaceutical, pharmacological, toxicological, and clinical data for the
investigational product. It provides investigators with information to understand the rationale
for the study and to manage risks to subjects .
Question 3
What is the purpose of a study endpoint?
A) To determine how many participants will be enrolled
B) To define the primary outcome measure that will be used to assess the study's objective
C) To set the budget for the clinical trial
D) To determine the statistical method used
Answer: B) To define the primary outcome measure that will be used to assess the study's
objective
Rationale: An endpoint is a specific measurement or observation used to determine whether
the study's objective has been met. Primary endpoints are the most important outcomes used
, to evaluate the treatment effect. Endpoints must be defined clearly in the protocol to ensure
consistent measurement across all sites .
Question 4
A study uses a randomization schedule to assign subjects to treatment groups. The purpose of
randomization is to:
A) Ensure that every subject receives the active treatment
B) Minimize selection bias and balance known and unknown prognostic factors
C) Reduce the number of subjects needed
D) Guarantee that the study is double-blind
Answer: B) Minimize selection bias and balance known and unknown prognostic factors
Rationale: Randomization is a fundamental principle of clinical trial design that helps ensure
comparability between treatment groups. By randomly assigning subjects, the study reduces
the risk of selection bias and helps ensure that known and unknown prognostic factors are
balanced across groups .
Question 5
What is the difference between a protocol deviation and a protocol violation?
A) A deviation is always intentional; a violation is unintentional
B) A violation is a significant departure that affects the integrity of the study; a deviation is a
minor departure
C) There is no difference
D) A deviation must be reported to the FDA; a violation must not
Answer: B) A violation is a significant departure that affects the integrity of the study; a
deviation is a minor departure
Rationale: A protocol violation is a significant departure from the protocol that may affect the
validity of the study results or the rights, safety, or welfare of subjects. A deviation is a minor
departure that does not substantially affect the study. Both must be documented, but
violations require more urgent reporting .
Question 6
What is meant by a "screen failure" in a clinical trial?
EXAM OVERVIEW
The ACRP Certified Clinical Research Coordinator (CCRC®) exam validates expertise in
managing clinical trials. The exam content is organized into six key domains based on the ACRP
Examination Content Outline (ECO):
Domain Percentage
Ethical and Participant Safety Considerations 19%
Clinical Trial Operations (GCPs) 23%
Study and Site Management 22%
Product Development and Regulation 13%
Data Management and Informatics 13%
Scientific Concepts and Research Design 8%
DOMAIN 1: SCIENTIFIC CONCEPTS AND RESEARCH DESIGN (Questions 1-12)
Question 1
A clinical trial is designed to compare a new investigational drug against a placebo. Neither the
participants nor the study staff know which treatment is being administered. What type of
study design is this?
A) Open-label
B) Single-blind
,C) Double-blind
D) Crossover
Answer: C) Double-blind
Rationale: In a double-blind study, neither the participants nor the study staff know the
treatment assignments. This minimizes bias in both participant reporting and investigator
assessment. Single-blind (B) means only one party is blinded. Open-label (A) means everyone
knows the treatment. A crossover design (D) involves participants receiving both treatments at
different times.
Question 2
A sponsor company is preparing an Investigational Brochure for a new drug. Which of the
following is a required element?
A) The drug's retail price
B) A summary of nonclinical and clinical data relevant to human safety
C) The marketing strategy for the drug
D) The names of all investigators who will use the drug
Answer: B) A summary of nonclinical and clinical data relevant to human safety
Rationale: The Investigational Brochure (IB) is a critical document that summarizes the physical,
chemical, pharmaceutical, pharmacological, toxicological, and clinical data for the
investigational product. It provides investigators with information to understand the rationale
for the study and to manage risks to subjects .
Question 3
What is the purpose of a study endpoint?
A) To determine how many participants will be enrolled
B) To define the primary outcome measure that will be used to assess the study's objective
C) To set the budget for the clinical trial
D) To determine the statistical method used
Answer: B) To define the primary outcome measure that will be used to assess the study's
objective
Rationale: An endpoint is a specific measurement or observation used to determine whether
the study's objective has been met. Primary endpoints are the most important outcomes used
, to evaluate the treatment effect. Endpoints must be defined clearly in the protocol to ensure
consistent measurement across all sites .
Question 4
A study uses a randomization schedule to assign subjects to treatment groups. The purpose of
randomization is to:
A) Ensure that every subject receives the active treatment
B) Minimize selection bias and balance known and unknown prognostic factors
C) Reduce the number of subjects needed
D) Guarantee that the study is double-blind
Answer: B) Minimize selection bias and balance known and unknown prognostic factors
Rationale: Randomization is a fundamental principle of clinical trial design that helps ensure
comparability between treatment groups. By randomly assigning subjects, the study reduces
the risk of selection bias and helps ensure that known and unknown prognostic factors are
balanced across groups .
Question 5
What is the difference between a protocol deviation and a protocol violation?
A) A deviation is always intentional; a violation is unintentional
B) A violation is a significant departure that affects the integrity of the study; a deviation is a
minor departure
C) There is no difference
D) A deviation must be reported to the FDA; a violation must not
Answer: B) A violation is a significant departure that affects the integrity of the study; a
deviation is a minor departure
Rationale: A protocol violation is a significant departure from the protocol that may affect the
validity of the study results or the rights, safety, or welfare of subjects. A deviation is a minor
departure that does not substantially affect the study. Both must be documented, but
violations require more urgent reporting .
Question 6
What is meant by a "screen failure" in a clinical trial?
