1|Page
ACRP CCRA Actual Final Exam Newest 2025-2026/ ACRP
CCRA Exam Preparation / ACRP CCRA Practice Exam
With Complete 200 Questions And Correct Detailed Answers
|Already Graded A+(Newest Version!)
As a foundation for quality control the individuals that implement and
follow the systems much have which of the following characteristics? -
ANSWER-- Solid understanding of the processes in place
- Rationale behind why each system is required
- Rationale behind why each SOP is required
Protocol adherence is derived from what? - ANSWER-Good training
techniques
The concept of pouring the pieces out of the box, trying to put the
objects together as quickly as possible, then rebuilding it later is an
example of what type of approach? - ANSWER-Retroactive approach
What are three techniques used for process improvement? - ANSWER--
Correction and prevention implementation
- Identify plans for process management
- Conducting a RCA to identify cause of error(s)
,2|Page
What's an example of controlling processes? - ANSWER-Identifying a
plan for ongoing management, identify key leaders, and required skills.
What are three applications of adult learning? - ANSWER-- Problem
based learning (PBL)
- Clinical problem solving
- Problems require different expertise
What is a tool to identify gap in performance? - ANSWER-Conducting a
RCA
True or False? In the US, device trials are to be conducted under CFR
part 812. - ANSWER-True
Which countries adhere to ICH GCP guideline to facilitate the mutual
acceptance of clinical data? - ANSWER-Japan, Canada, Switzerland,
US, EU
What is a true statement regarding FDA guidance for industry
investigator responsibilities? - ANSWER-FDAs guidance documents do
not establish legally enforceable responsibilities. Instead, guidances
describe the agency's current thinking on the topic and should be viewed
only as recommendations, unless specific regulatory or statutory
requirements are sited.
,3|Page
What are expectations in relation to the qualifications of an investigator?
- ANSWER-- Be qualified by education, training, and experience to
assume responsibility for the proper conduct of the trial.
- Be thoroughly familiar with appropriate use of IP
- Permit for monitoring and auditing by the sponsor and inspection by
the appropriate regulatory authorities
True or False? If the investigator is a non-physician, the investor should
make adequate provision for an necessary medical care. - ANSWER-
True
What are three true statements with respect to protecting the rights,
safety, and welfare of study subjects? - ANSWER-- Providing subjects
with method of communication with the investigator or qualified
designee for questions or concerns
- Adhering to the protocol so that study subjects aren't exposed to
unreasonable risk
- Providing reasonable access to needed medical care
True or False? Protecting the rights, safety, and well-being of clinical
trial subjects is the most important element of investigator responsibility.
- ANSWER-True
True or False? Within the US, clinical investigations of drugs and
biological products must be conducted in accordance with 21 CFR part
312. - ANSWER-True
, 4|Page
What areas are applicable to assess the adequacy of supervision by an
investigator? - ANSWER-- Whether individuals who were delegated
tasks were qualified to reform such tasks
- Whether study staff received adequate training on how to conduct the
delegated tasks
- Whether there was adequate supervision and involvement in the
ongoing conduct of the study
Which entities should be listed on form 1572? - ANSWER-- PI
- Facility where research is being conducted
- IRB
When should 1572 be modified? - ANSWER-- Staff change
- Lab change
What documentation must accompany the 1572 submission? -
ANSWER-PI CV
The 1572 is an agreement between the PO and who? - ANSWER-FDA
To whom is 1572 submitted? - ANSWER-Sponsor/CRO
ACRP CCRA Actual Final Exam Newest 2025-2026/ ACRP
CCRA Exam Preparation / ACRP CCRA Practice Exam
With Complete 200 Questions And Correct Detailed Answers
|Already Graded A+(Newest Version!)
As a foundation for quality control the individuals that implement and
follow the systems much have which of the following characteristics? -
ANSWER-- Solid understanding of the processes in place
- Rationale behind why each system is required
- Rationale behind why each SOP is required
Protocol adherence is derived from what? - ANSWER-Good training
techniques
The concept of pouring the pieces out of the box, trying to put the
objects together as quickly as possible, then rebuilding it later is an
example of what type of approach? - ANSWER-Retroactive approach
What are three techniques used for process improvement? - ANSWER--
Correction and prevention implementation
- Identify plans for process management
- Conducting a RCA to identify cause of error(s)
,2|Page
What's an example of controlling processes? - ANSWER-Identifying a
plan for ongoing management, identify key leaders, and required skills.
What are three applications of adult learning? - ANSWER-- Problem
based learning (PBL)
- Clinical problem solving
- Problems require different expertise
What is a tool to identify gap in performance? - ANSWER-Conducting a
RCA
True or False? In the US, device trials are to be conducted under CFR
part 812. - ANSWER-True
Which countries adhere to ICH GCP guideline to facilitate the mutual
acceptance of clinical data? - ANSWER-Japan, Canada, Switzerland,
US, EU
What is a true statement regarding FDA guidance for industry
investigator responsibilities? - ANSWER-FDAs guidance documents do
not establish legally enforceable responsibilities. Instead, guidances
describe the agency's current thinking on the topic and should be viewed
only as recommendations, unless specific regulatory or statutory
requirements are sited.
,3|Page
What are expectations in relation to the qualifications of an investigator?
- ANSWER-- Be qualified by education, training, and experience to
assume responsibility for the proper conduct of the trial.
- Be thoroughly familiar with appropriate use of IP
- Permit for monitoring and auditing by the sponsor and inspection by
the appropriate regulatory authorities
True or False? If the investigator is a non-physician, the investor should
make adequate provision for an necessary medical care. - ANSWER-
True
What are three true statements with respect to protecting the rights,
safety, and welfare of study subjects? - ANSWER-- Providing subjects
with method of communication with the investigator or qualified
designee for questions or concerns
- Adhering to the protocol so that study subjects aren't exposed to
unreasonable risk
- Providing reasonable access to needed medical care
True or False? Protecting the rights, safety, and well-being of clinical
trial subjects is the most important element of investigator responsibility.
- ANSWER-True
True or False? Within the US, clinical investigations of drugs and
biological products must be conducted in accordance with 21 CFR part
312. - ANSWER-True
, 4|Page
What areas are applicable to assess the adequacy of supervision by an
investigator? - ANSWER-- Whether individuals who were delegated
tasks were qualified to reform such tasks
- Whether study staff received adequate training on how to conduct the
delegated tasks
- Whether there was adequate supervision and involvement in the
ongoing conduct of the study
Which entities should be listed on form 1572? - ANSWER-- PI
- Facility where research is being conducted
- IRB
When should 1572 be modified? - ANSWER-- Staff change
- Lab change
What documentation must accompany the 1572 submission? -
ANSWER-PI CV
The 1572 is an agreement between the PO and who? - ANSWER-FDA
To whom is 1572 submitted? - ANSWER-Sponsor/CRO
