ACRP CCRA EXAM 2026 | Association of Clinical
Research Professionals (ACRP) Certified Clinical
Research Associate Exam | Updated Version |
Brand New Version!
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.
,What is essential to keep in mind when determining actions to mitigate potential
risks? ---------CORRECT ANSWER-----------------The make a risk-based decision
following a risk management plan.
Where should potential risks be documented? ---------CORRECT ANSWER-------------
----A risk management plan.
What skills are most affected by the introduction of risk-based decision making? --
-------CORRECT ANSWER------------------ Motivational skills
- Change management
Whats the most important thing to keep in mind when introducing risk-based
decision making into clinical research? ---------CORRECT ANSWER-----------------The
focus of clinical research is on patient safety and quality data.
At what time period during the trial is a risk management plan benefical? ---------
CORRECT ANSWER-----------------At all stages of the trial.
When should a risk management plan be updated? ---------CORRECT ANSWER------
-----------Continuously
,Whats the first step in the RBDM process? ---------CORRECT ANSWER-----------------
Determining an end goal.
What are the objectives of RBDM in clinical trials? ---------CORRECT ANSWER--------
---------- Targeting quality control activities to the most vital pints to ensure quality
data
- Applying risk avoidance and risk mitigation strategies to avoid endangering
subject safety
What are two true statements about RBDM? ---------CORRECT ANSWER---------------
--- Risk-based decision making is a process, not a one-time activity
- RBDM is a continuous process in which the endpoint leads back to earlier stages
Planning for how to handle risks include what two activities? ---------CORRECT
ANSWER------------------ Risk avoidance
- Risk mitigation
What are two possible risk mitigation strategies? ---------CORRECT ANSWER---------
--------- Training staff
- Implementing SOPs
, What are the sites responsibilities regarding QC? ---------CORRECT ANSWER---------
--------- Sites need to ensure high quality of data
- Sites need to conduct their own QC
In the RBDM process, what's the next step after determining the end goal? ---------
CORRECT ANSWER-----------------Risk assessment.
True or False? A CRC claims that you doin't need to assess the impact of your risk
management efforts on an ongoing basis as long as the plan was executed
properly. ---------CORRECT ANSWER-----------------False
How is the seriousness of a risk calculated? ---------CORRECT ANSWER-----------------
Likelihood of risk x consequences of risk.
True or False? RBDM only applies to RBM strategies. ---------CORRECT ANSWER-----
------------False
What are three activities that should be considered by sites in a risk-based
monitoring environment? ---------CORRECT ANSWER------------------ Implementing
additional quality control measures
- Revising study contracts
- Updating internal SOPs
Research Professionals (ACRP) Certified Clinical
Research Associate Exam | Updated Version |
Brand New Version!
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.
,What is essential to keep in mind when determining actions to mitigate potential
risks? ---------CORRECT ANSWER-----------------The make a risk-based decision
following a risk management plan.
Where should potential risks be documented? ---------CORRECT ANSWER-------------
----A risk management plan.
What skills are most affected by the introduction of risk-based decision making? --
-------CORRECT ANSWER------------------ Motivational skills
- Change management
Whats the most important thing to keep in mind when introducing risk-based
decision making into clinical research? ---------CORRECT ANSWER-----------------The
focus of clinical research is on patient safety and quality data.
At what time period during the trial is a risk management plan benefical? ---------
CORRECT ANSWER-----------------At all stages of the trial.
When should a risk management plan be updated? ---------CORRECT ANSWER------
-----------Continuously
,Whats the first step in the RBDM process? ---------CORRECT ANSWER-----------------
Determining an end goal.
What are the objectives of RBDM in clinical trials? ---------CORRECT ANSWER--------
---------- Targeting quality control activities to the most vital pints to ensure quality
data
- Applying risk avoidance and risk mitigation strategies to avoid endangering
subject safety
What are two true statements about RBDM? ---------CORRECT ANSWER---------------
--- Risk-based decision making is a process, not a one-time activity
- RBDM is a continuous process in which the endpoint leads back to earlier stages
Planning for how to handle risks include what two activities? ---------CORRECT
ANSWER------------------ Risk avoidance
- Risk mitigation
What are two possible risk mitigation strategies? ---------CORRECT ANSWER---------
--------- Training staff
- Implementing SOPs
, What are the sites responsibilities regarding QC? ---------CORRECT ANSWER---------
--------- Sites need to ensure high quality of data
- Sites need to conduct their own QC
In the RBDM process, what's the next step after determining the end goal? ---------
CORRECT ANSWER-----------------Risk assessment.
True or False? A CRC claims that you doin't need to assess the impact of your risk
management efforts on an ongoing basis as long as the plan was executed
properly. ---------CORRECT ANSWER-----------------False
How is the seriousness of a risk calculated? ---------CORRECT ANSWER-----------------
Likelihood of risk x consequences of risk.
True or False? RBDM only applies to RBM strategies. ---------CORRECT ANSWER-----
------------False
What are three activities that should be considered by sites in a risk-based
monitoring environment? ---------CORRECT ANSWER------------------ Implementing
additional quality control measures
- Revising study contracts
- Updating internal SOPs
