ACRP CCRC Exam Review (NEW 2024/
2025 Update) Questions and Verified
Answers| 100% Correct| Grade A
QUESTION
What should you do if you need to make changes to information entered in a CRF?
Answer:
1. insert an explanation for the change
2. date & initial the change
3. do not obscure the original entry (e.g. should have just one line through--NOT blacked out,
deleted, etc.)
QUESTION
How long should essential documents be retained after study completion?
Answer:
2 years
QUESTION
How long do IRBs hold records?
Answer:
3 years
QUESTION
Which SAEs should be reported to SPONSOR & when should they be reported?
Answer:
ALL SAEs reported IMMEDIATELY
,(unless the IB/protocol deemed the specific SAE as unnecessary to report)
QUESTION
True or False: The investigator cannot supply IRB and Sponsor with private information from a
deceased participant, such as medical death reports and autopsy results.
Answer:
FALSE.
The investigator SHOULD provide these if either entity asks for these additional documents
QUESTION
Which entity(ies) have the ability to terminate/suspend the trial?
Answer:
1. IRB
2. Sponsor
3. Investigator (at their site only)
QUESTION
Sponsor's Quality Management using Risk-Based Approach
1. Critical Process & Data Identification
Answer:
-during protocol development
-ensure participant protection
-ensure reliability of results
QUESTION
Sponsor's Quality Management using Risk-Based Approach
2. Risk Identification
,Answer:
Identify risks at 2 levels:
-system level (SOPs, personnel, software, etc.)
-clinical trial level (design, data collection, ICFs, etc.)
QUESTION
Sponsor's Quality Management using Risk-Based Approach
3. Risk Evaluation
Answer:
Evaluate:
-likelihood of errors
-extent that errors would be detectable
-impact of errors on pt. protection & reliability of results
QUESTION
Sponsor's Quality Management using Risk-Based Approach
4. Risk Control
Answer:
-decide which risks to try to reduce and/or just accept
-establish pre-defined quality tolerance (based on medical & statistical characteristics of
variables)
QUESTION
Sponsor's Quality Management using Risk-Based Approach
5. Risk Communication
Answer:
-document everything
-inform risk control plan to all parties involved
, QUESTION
Sponsor's Quality Management using Risk-Based Approach
6. Risk Review
Answer:
-periodically assess the risk control plan
QUESTION
Sponsor's Quality Management using Risk-Based Approach
7. Risk Reporting
Answer:
-summarize the quality management approach in the CSR
QUESTION
Review of accumulating data from centralized monitoring can be used to:
Answer:
1. identify missing/inconsistent data & protocol deviations
2. examine data trends within & across sites
3. evaluate for errors in data collection or reporting
4. analyze site characteristics/performance
5. select sites needing on-site monitoring
QUESTION
What information should be included in the protocol under "subject withdrawal criteria"?
Answer:
1. when & how to withdraw pts from trial OR IP
2. type & timing of data to collect from withdrawn pts
3. whether & how they'll be replaced
2025 Update) Questions and Verified
Answers| 100% Correct| Grade A
QUESTION
What should you do if you need to make changes to information entered in a CRF?
Answer:
1. insert an explanation for the change
2. date & initial the change
3. do not obscure the original entry (e.g. should have just one line through--NOT blacked out,
deleted, etc.)
QUESTION
How long should essential documents be retained after study completion?
Answer:
2 years
QUESTION
How long do IRBs hold records?
Answer:
3 years
QUESTION
Which SAEs should be reported to SPONSOR & when should they be reported?
Answer:
ALL SAEs reported IMMEDIATELY
,(unless the IB/protocol deemed the specific SAE as unnecessary to report)
QUESTION
True or False: The investigator cannot supply IRB and Sponsor with private information from a
deceased participant, such as medical death reports and autopsy results.
Answer:
FALSE.
The investigator SHOULD provide these if either entity asks for these additional documents
QUESTION
Which entity(ies) have the ability to terminate/suspend the trial?
Answer:
1. IRB
2. Sponsor
3. Investigator (at their site only)
QUESTION
Sponsor's Quality Management using Risk-Based Approach
1. Critical Process & Data Identification
Answer:
-during protocol development
-ensure participant protection
-ensure reliability of results
QUESTION
Sponsor's Quality Management using Risk-Based Approach
2. Risk Identification
,Answer:
Identify risks at 2 levels:
-system level (SOPs, personnel, software, etc.)
-clinical trial level (design, data collection, ICFs, etc.)
QUESTION
Sponsor's Quality Management using Risk-Based Approach
3. Risk Evaluation
Answer:
Evaluate:
-likelihood of errors
-extent that errors would be detectable
-impact of errors on pt. protection & reliability of results
QUESTION
Sponsor's Quality Management using Risk-Based Approach
4. Risk Control
Answer:
-decide which risks to try to reduce and/or just accept
-establish pre-defined quality tolerance (based on medical & statistical characteristics of
variables)
QUESTION
Sponsor's Quality Management using Risk-Based Approach
5. Risk Communication
Answer:
-document everything
-inform risk control plan to all parties involved
, QUESTION
Sponsor's Quality Management using Risk-Based Approach
6. Risk Review
Answer:
-periodically assess the risk control plan
QUESTION
Sponsor's Quality Management using Risk-Based Approach
7. Risk Reporting
Answer:
-summarize the quality management approach in the CSR
QUESTION
Review of accumulating data from centralized monitoring can be used to:
Answer:
1. identify missing/inconsistent data & protocol deviations
2. examine data trends within & across sites
3. evaluate for errors in data collection or reporting
4. analyze site characteristics/performance
5. select sites needing on-site monitoring
QUESTION
What information should be included in the protocol under "subject withdrawal criteria"?
Answer:
1. when & how to withdraw pts from trial OR IP
2. type & timing of data to collect from withdrawn pts
3. whether & how they'll be replaced
