ACRP CCRA EXAM ACTUAL EXAM 2026 | ASSOCIATION
OF CLINICAL RESEARCH PROFESSIONALS (ACRP)
CERTIFIED CLINICAL RESEARCH ASSOCIATE EXAM |
UPDATED VERSION | JUST RELEASED
What is the key difference between quality improvement and quality
assurance activities? ---------CORRECT ANSWER-----------------Can be
performed by persons involved in doing the work.
What are the elements of quality management system? ---------
CORRECT ANSWER------------------ Quality planning
- Quality assurance
- Quality control
What is part of a quality management plan? ---------CORRECT ANSWER--
---------------- Quality policy statement
- Quality goals
- Organizational structure with defined roles
What documents support quality control? ---------CORRECT ANSWER-----
------------- SOPS,
,- Concomitant medication log
Quality standards are set by? ---------CORRECT ANSWER------------------
Regulatory bodies
- IRB/IECs
What are the basic steps of risk management? ---------CORRECT
ANSWER------------------ Analyze risk
- Identify risk
- Control risk
Adhering to the principles represented in ALCOA-C support? ---------
CORRECT ANSWER-----------------Good documentation practice.
What are the correct order of steps CAPA performs? ---------CORRECT
ANSWER------------------ Identify issue
- Determine root cause
- Implement plan for correction
- Assess effectiveness of correction
,Having which two people sign and date the consent form is a quality
standard for the informed consent documentation? ---------CORRECT
ANSWER-----------------The subject and the person obtaining consent.
True or False. Moving away from preventing problems to identifying
and correcting problems is a key paradigm shift taking place in clinical
trial conduct. ---------CORRECT ANSWER-----------------False
True or False. When engaged in quality improvement activities, it's
important to identify who is to blame for quality failure? ---------
CORRECT ANSWER-----------------False
What skills are essential for making risk based decision making
successful? ---------CORRECT ANSWER------------------ Quality control skills
- Motivational skills
- Change management skills
, What are steps in risk assessment? ---------CORRECT ANSWER--------------
---- Identifying the consequences of risks occurring
- Categorizing risks
- Identifying risks
What risk should be appointed highest priority to manage in view of
patient safety and data quality? ---------CORRECT ANSWER-----------------
Insufficient IP accountability.
When practicing RBDM in clinical research, what should be the primary
focus? ---------CORRECT ANSWER-----------------Subject safety and quality
of the data.
When assessing the seriousness of a risk, what are the primary
considerations that need to be taken into account? ---------CORRECT
ANSWER------------------ The likelihood of occurrence
- The consequences of the occurrence
When assessing the seriousness of a risk, what should the risk be
compared to? ---------CORRECT ANSWER-----------------Standard clinical
practice.
OF CLINICAL RESEARCH PROFESSIONALS (ACRP)
CERTIFIED CLINICAL RESEARCH ASSOCIATE EXAM |
UPDATED VERSION | JUST RELEASED
What is the key difference between quality improvement and quality
assurance activities? ---------CORRECT ANSWER-----------------Can be
performed by persons involved in doing the work.
What are the elements of quality management system? ---------
CORRECT ANSWER------------------ Quality planning
- Quality assurance
- Quality control
What is part of a quality management plan? ---------CORRECT ANSWER--
---------------- Quality policy statement
- Quality goals
- Organizational structure with defined roles
What documents support quality control? ---------CORRECT ANSWER-----
------------- SOPS,
,- Concomitant medication log
Quality standards are set by? ---------CORRECT ANSWER------------------
Regulatory bodies
- IRB/IECs
What are the basic steps of risk management? ---------CORRECT
ANSWER------------------ Analyze risk
- Identify risk
- Control risk
Adhering to the principles represented in ALCOA-C support? ---------
CORRECT ANSWER-----------------Good documentation practice.
What are the correct order of steps CAPA performs? ---------CORRECT
ANSWER------------------ Identify issue
- Determine root cause
- Implement plan for correction
- Assess effectiveness of correction
,Having which two people sign and date the consent form is a quality
standard for the informed consent documentation? ---------CORRECT
ANSWER-----------------The subject and the person obtaining consent.
True or False. Moving away from preventing problems to identifying
and correcting problems is a key paradigm shift taking place in clinical
trial conduct. ---------CORRECT ANSWER-----------------False
True or False. When engaged in quality improvement activities, it's
important to identify who is to blame for quality failure? ---------
CORRECT ANSWER-----------------False
What skills are essential for making risk based decision making
successful? ---------CORRECT ANSWER------------------ Quality control skills
- Motivational skills
- Change management skills
, What are steps in risk assessment? ---------CORRECT ANSWER--------------
---- Identifying the consequences of risks occurring
- Categorizing risks
- Identifying risks
What risk should be appointed highest priority to manage in view of
patient safety and data quality? ---------CORRECT ANSWER-----------------
Insufficient IP accountability.
When practicing RBDM in clinical research, what should be the primary
focus? ---------CORRECT ANSWER-----------------Subject safety and quality
of the data.
When assessing the seriousness of a risk, what are the primary
considerations that need to be taken into account? ---------CORRECT
ANSWER------------------ The likelihood of occurrence
- The consequences of the occurrence
When assessing the seriousness of a risk, what should the risk be
compared to? ---------CORRECT ANSWER-----------------Standard clinical
practice.
