ACRP CCRC Exam Prep (NEW 2024/ 2025
Update) Questions and Verified Answers|
100% Correct| Grade A
QUESTION
What are the correct order of steps CAPA performs?
Answer:
- Identify issue
- Determine root cause
- Implement plan for correction
- Assess effectiveness of correction
QUESTION
Having which two people sign and date the consent form is a quality standard for the informed
consent documentation?
Answer:
The subject and the person obtaining consent.
QUESTION
True or False. Moving away from preventing problems to identifying and correcting problems is
a key paradigm shift taking place in clinical trial conduct.
Answer:
False
QUESTION
True or False. When engaged in quality improvement activities, it's important to identify who is
to blame for quality failure?
,Answer:
False
QUESTION
What skills are essential for making risk based decision making successful?
Answer:
- Quality control skills
- Motivational skills
- Change management skills
QUESTION
What are steps in risk assessment?
Answer:
- Identifying the consequences of risks occurring
- Categorizing risks
- Identifying risks
QUESTION
What risk should be appointed highest priority to manage in view of patient safety and data
quality?
Answer:
Insufficient IP accountability.
QUESTION
When practicing RBDM in clinical research, what should be the primary focus?
Answer:
Subject safety and quality of the data.
,QUESTION
When assessing the seriousness of a risk, what are the primary considerations that need to be
taken into account?
Answer:
- The likelihood of occurrence
- The consequences of the occurrence
QUESTION
When assessing the seriousness of a risk, what should the risk be compared to?
Answer:
Standard clinical practice.
QUESTION
What is essential to keep in mind when determining actions to mitigate potential risks?
Answer:
The make a risk-based decision following a risk management plan.
QUESTION
Where should potential risks be documented?
Answer:
A risk management plan.
QUESTION
What skills are most affected by the introduction of risk-based decision making?
Answer:
- Motivational skills
, - Change management
QUESTION
Whats the most important thing to keep in mind when introducing risk-based decision making
into clinical research?
Answer:
The focus of clinical research is on patient safety and quality data.
QUESTION
At what time period during the trial is a risk management plan benefical?
Answer:
At all stages of the trial.
QUESTION
When should a risk management plan be updated?
Answer:
Continuously
QUESTION
Whats the first step in the RBDM process?
Answer:
Determining an end goal.
QUESTION
What are the objectives of RBDM in clinical trials?
Update) Questions and Verified Answers|
100% Correct| Grade A
QUESTION
What are the correct order of steps CAPA performs?
Answer:
- Identify issue
- Determine root cause
- Implement plan for correction
- Assess effectiveness of correction
QUESTION
Having which two people sign and date the consent form is a quality standard for the informed
consent documentation?
Answer:
The subject and the person obtaining consent.
QUESTION
True or False. Moving away from preventing problems to identifying and correcting problems is
a key paradigm shift taking place in clinical trial conduct.
Answer:
False
QUESTION
True or False. When engaged in quality improvement activities, it's important to identify who is
to blame for quality failure?
,Answer:
False
QUESTION
What skills are essential for making risk based decision making successful?
Answer:
- Quality control skills
- Motivational skills
- Change management skills
QUESTION
What are steps in risk assessment?
Answer:
- Identifying the consequences of risks occurring
- Categorizing risks
- Identifying risks
QUESTION
What risk should be appointed highest priority to manage in view of patient safety and data
quality?
Answer:
Insufficient IP accountability.
QUESTION
When practicing RBDM in clinical research, what should be the primary focus?
Answer:
Subject safety and quality of the data.
,QUESTION
When assessing the seriousness of a risk, what are the primary considerations that need to be
taken into account?
Answer:
- The likelihood of occurrence
- The consequences of the occurrence
QUESTION
When assessing the seriousness of a risk, what should the risk be compared to?
Answer:
Standard clinical practice.
QUESTION
What is essential to keep in mind when determining actions to mitigate potential risks?
Answer:
The make a risk-based decision following a risk management plan.
QUESTION
Where should potential risks be documented?
Answer:
A risk management plan.
QUESTION
What skills are most affected by the introduction of risk-based decision making?
Answer:
- Motivational skills
, - Change management
QUESTION
Whats the most important thing to keep in mind when introducing risk-based decision making
into clinical research?
Answer:
The focus of clinical research is on patient safety and quality data.
QUESTION
At what time period during the trial is a risk management plan benefical?
Answer:
At all stages of the trial.
QUESTION
When should a risk management plan be updated?
Answer:
Continuously
QUESTION
Whats the first step in the RBDM process?
Answer:
Determining an end goal.
QUESTION
What are the objectives of RBDM in clinical trials?
