2025 ACRP CCRC EXAM PREP 300 QUESTIONS
AND CORRECT DETAILED ANSWERS (100%
CORRECT ANSWERS) ACRP CCRC EXAM
PRACTICE QS AND AS (NEWEST!)
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
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
pg. 1
,- Whether there was adequate supervision and involvement in the ongoing conduct
of the study
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
What are expected or possible consequences of over-estimation of recruitment
potential? - ANSWER-- The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
What should be the first consideration when conducting a clinical trial? -
ANSWER-Subject welfare
When is the investigator allowed to deviate from the protocol? - ANSWER-When
there is an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an immediate hazard to a
patient, according to ICH E6 guidelines who world they need to report the
deviation and rationale to, if appropriate? - ANSWER-- The Sponsor
- IRB/IEC
- Regulatory Authorities
pg. 2
,Which conditions should be fulfilled when enrolling a subject into your trial? -
ANSWER-- Subject meets all inclusion criteria
- Subject has given written informed consent
You've been delegated to handle the storage and inventory of IP. The study drug
must be stored below 25C/77F. On a summer Monday morning you discover that
the temperature recording machine in the storage room has failed so you doin't
know what the temperature has been over the weekend. You check the current
temperature; it's 24C/75F. What should you do? - ANSWER-- Contact the
Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
A protocol amendment was issued for a trial. Your site received IRB approval for
the amendment and wants to implement the increase in PO dose for your trial
subjects as identified in the amendment trial subjects. As delegated consenting
duties you must re-consent trial subjects before being able to administer the
adjusted dose. You decide to only re-consent trial subjects who are still taking the
IP and not from the subjects woh already completed their drug intake period. Is this
allowed according the E6 Guideline for GCP? - ANSWER-No, these subjects are
still enrolled in the trial and therefore need to be updated on any changes to the
protocol.
A trial subject informs you she no longer wants to participant in the trial. What
should your course of action be? - ANSWER-You ask if the patient wishes to share
the reason why she wants to leave the trial. If not, you exclude the subject from the
trial immediately.
A patient cannot recall the name of the heart condition medication he took a few
years ago. This is important information for deciding whether the patient may be
enrolled in a clinical trial (IC/EC). What's your best course of action? - ANSWER-
You attempt to retrieve the patients medical history by contacting previous
caregivers and you wait for additional information before enrollment.
pg. 3
, Who has ultimate trial responsibility for each subject? - ANSWER-The principle
investigator.
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)
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
pg. 4
AND CORRECT DETAILED ANSWERS (100%
CORRECT ANSWERS) ACRP CCRC EXAM
PRACTICE QS AND AS (NEWEST!)
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
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
pg. 1
,- Whether there was adequate supervision and involvement in the ongoing conduct
of the study
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
What are expected or possible consequences of over-estimation of recruitment
potential? - ANSWER-- The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
What should be the first consideration when conducting a clinical trial? -
ANSWER-Subject welfare
When is the investigator allowed to deviate from the protocol? - ANSWER-When
there is an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an immediate hazard to a
patient, according to ICH E6 guidelines who world they need to report the
deviation and rationale to, if appropriate? - ANSWER-- The Sponsor
- IRB/IEC
- Regulatory Authorities
pg. 2
,Which conditions should be fulfilled when enrolling a subject into your trial? -
ANSWER-- Subject meets all inclusion criteria
- Subject has given written informed consent
You've been delegated to handle the storage and inventory of IP. The study drug
must be stored below 25C/77F. On a summer Monday morning you discover that
the temperature recording machine in the storage room has failed so you doin't
know what the temperature has been over the weekend. You check the current
temperature; it's 24C/75F. What should you do? - ANSWER-- Contact the
Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
A protocol amendment was issued for a trial. Your site received IRB approval for
the amendment and wants to implement the increase in PO dose for your trial
subjects as identified in the amendment trial subjects. As delegated consenting
duties you must re-consent trial subjects before being able to administer the
adjusted dose. You decide to only re-consent trial subjects who are still taking the
IP and not from the subjects woh already completed their drug intake period. Is this
allowed according the E6 Guideline for GCP? - ANSWER-No, these subjects are
still enrolled in the trial and therefore need to be updated on any changes to the
protocol.
A trial subject informs you she no longer wants to participant in the trial. What
should your course of action be? - ANSWER-You ask if the patient wishes to share
the reason why she wants to leave the trial. If not, you exclude the subject from the
trial immediately.
A patient cannot recall the name of the heart condition medication he took a few
years ago. This is important information for deciding whether the patient may be
enrolled in a clinical trial (IC/EC). What's your best course of action? - ANSWER-
You attempt to retrieve the patients medical history by contacting previous
caregivers and you wait for additional information before enrollment.
pg. 3
, Who has ultimate trial responsibility for each subject? - ANSWER-The principle
investigator.
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)
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
pg. 4
