ACRP CCRC Exam (Latest 2024/ 2025
Update) Practice Questions and Verified
Answers| 100% Correct| Grade A
QUESTION
All of the following are regulator documents EXCEPT A. Informed consent
B. Protocol signature page
C. Laboratory certification
D. Confidentiality agreement
Answer:
D
- References: E6 1.49, E8 1; E6 1.28
- Note: Regulatory documents demonstrates the compliance of the investigator. Sponsor and
IRB/IEC with the standards of Good Clinical Practice and with all applicable regulatory
requirements.
- A is incorrect: the informed consent is a regulatory document because it is
a process by which a subject confirms willingness to participate in a trial. This document has to
be approved by the IRB/IEC.
- B is incorrect: the protocol signature page is signed by the PI and sponsor to document
agreement to the protocol and amendments
- C is incorrect: a laboratory certification documents competence of the facility to perform
required tests and support reliability of results
- D is correct: a confidentiality agreement is a nondisclosure contract entered into by the sponsor
and the investigator and is not governed by regulatory authorities
QUESTION
A subject is participating in a lipid-lowering clinical trial. Before the
12-month visit, the CRC receives an amendment from the sponsor, which includes the addition
of quality-of-life measurements to be collected at the
12-month visit. To ensure appropriate collection of this addition data, the CRC
should
A. Collect the data at the scheduled visit by verbally asking the subject the questions as indicated
in the revised, approved amendment
B. Assist the subject by providing the additional information for questions which the subject
states are unclear
C. Schedule the subject for an interim visit as soon as possible and complete the questionnaires
,D. Obtain the appropriate signature on the revised, approved consent, then have the subject
complete the questionnaires
Answer:
D
- References: E6 4.5.2
- A, B, and C are incorrect: The data should not be collected until the IRB approves the revision.
- D is correct: the reference E6 4.5.2 states that the investigator should not implement any
changes without favorable approval from the IRB/IEC for a protocol amendment unless there's a
hazard to the subject. The questionnaire does not represent a hazard, so nothing should be done
without the approval of the IRB/IEC which would include an updated, approved ICF for the
amended protocol.
QUESTION
A subject is upset and wants to know whom she should contact regard- ing her rights as a
research subject. The CRC should tell her to contact the
A. PI
B. Regulatory authority
C. Risk management department
D. Individual listed on the ICF
Answer:
D
- References: E6 4.8.10 (q)
- While it might be the PI, this reference includes elements of the informed consent that should
be included. Section (q) states that the person(s) to contact for further information regarding the
trial and the rights of trial subjects, and specifically who to
contact in the event of trial-related injury, should be in included. A, B, and C are not the best
answer. The purpose of the question is to ensure the candidate knows that this is referred to in the
ICF
QUESTION
The day before a CRA is to conduct an initiation visit, the CRC realizes that the IRB.IEC
approval letter has not yet been obtained. Which of the following should the CRC do FIRST?
A. Request an expedited IRB/IEC review
B. Reschedule the initiation visit
C. Call the IRB/IEC to check the status of the letter
D. Call the sponsor to have the files checked
Answer:
, C
- References: E6 8.2.7
- A is incorrect: the stem does not indicate that the IRB/IEC had reviewed the protocol or not
- B is incorrect: The visit would only need to be rescheduled if the protocol had NOT
been reviewed
- C is correct: Any additional action needed regarding the initiation visit would come
AFTER receiving the status of the approval letter
- D is incorrect: The sponsor does not receive approval notification directly from the
IRB/IEC
QUESTION
In addition to obtaining a signed informed consent form, which of the following should be
documented in the research record?
1.The time and date of the procedures will be performed
2.That the subject's questions were answered
2.The names of people present during the consent process
4. That no trial procedures were performed prior to consenting
A. 1 and 2 only B. 1 and 3 only C. 2 and 4 only
D. 3 and 4 only
Answer:
C
- References: E6 4.8.7; E6 4.8.8
- 1 and 3 are incorrect since these are not listed in the references. 2 and 4 are correct as these are
listed I the E6 reference. E6 4.8.7 speaks to answering a subject's questions. E6 4.8.8 talks about
the ICF needing to be signed and dated by the subject (etc) prior to a subject's participation.
- C is correct since it is the only option that contains both 2 and 4
QUESTION
The CRC reviewed a new protocol to prepare the trial budget for sub- mission to the sponsor.
According to the protocol, each subject is required to return for follow-up visits at 30 days, 6
months, and 1 year. At 30 days, the protocol requires a physical exam, and electrocardiogram,
and a chest x-ray.
At 6 months, the protocol requires a physical exam, and an electrocardiogram. At 1 year, the
protocol requires a physical exam, an electrocardiogram, and
a chest x-ray. The hospital charges $75 for the physical exam, $50 for the electrocardiogram, and
$100 for the chest x-ray. The 30 day and 1 year visits are considered standard of care for the
subjects. How much should the CRC budget per subject for the non-standard of care visits?
A. $125
B. $225
, C. $450
D. $575
Answer:
A
- Math calculation: Since the 30-day and 1 year visits are considered standard of care, they are
not to be included in the budget. Required at 6 months are: physical exam ($75) and
electrocardiogram ($50) for a total of $125.
QUESTION
A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the
CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in the
diaries for the first 7 days of the trial. Upon review with the subjects, there were no related
complaints. Which of the following should be the CRC's FIRST reaction?
A. Notify the sponsor
B. Contact the manufacturer
C. Inform the remaining 20 subjects
D. Replace existing thermometers with an alternate model
Answer:
A
- References: E6 5.1.1
- A is correct: the sponsor is responsible for maintaining quality assurance and control
- B is incorrect: the sponsor would contact the manufacturer
- C is incorrect: The CRC would inform the remaining subjects if instructed to do so by the
sponsor
- D is incorrect: The sponsor is responsible for supplying the equipment for this trial
QUESTION
A subject presents at a site with her husband after pre-qualifying on a phone screen. She states
that she is legally blind and cannot rad the ICF. A Braille ICF is not available. This subject is able
to sign her own name if her hand is guided to the signature line. Which of the following is the
BEST course of action to obtain legal consent for this subject?
A. The subject and an impartial witness can sign the ICF after it is read to them and she verbally
states her understanding
B. Her husband can sign the ICF for her after it has been read to the subject and she verbally
states her understanding
C. This subject does not qualify as she is unable to read the ICF herself and a
braille consent form is not available
Update) Practice Questions and Verified
Answers| 100% Correct| Grade A
QUESTION
All of the following are regulator documents EXCEPT A. Informed consent
B. Protocol signature page
C. Laboratory certification
D. Confidentiality agreement
Answer:
D
- References: E6 1.49, E8 1; E6 1.28
- Note: Regulatory documents demonstrates the compliance of the investigator. Sponsor and
IRB/IEC with the standards of Good Clinical Practice and with all applicable regulatory
requirements.
- A is incorrect: the informed consent is a regulatory document because it is
a process by which a subject confirms willingness to participate in a trial. This document has to
be approved by the IRB/IEC.
- B is incorrect: the protocol signature page is signed by the PI and sponsor to document
agreement to the protocol and amendments
- C is incorrect: a laboratory certification documents competence of the facility to perform
required tests and support reliability of results
- D is correct: a confidentiality agreement is a nondisclosure contract entered into by the sponsor
and the investigator and is not governed by regulatory authorities
QUESTION
A subject is participating in a lipid-lowering clinical trial. Before the
12-month visit, the CRC receives an amendment from the sponsor, which includes the addition
of quality-of-life measurements to be collected at the
12-month visit. To ensure appropriate collection of this addition data, the CRC
should
A. Collect the data at the scheduled visit by verbally asking the subject the questions as indicated
in the revised, approved amendment
B. Assist the subject by providing the additional information for questions which the subject
states are unclear
C. Schedule the subject for an interim visit as soon as possible and complete the questionnaires
,D. Obtain the appropriate signature on the revised, approved consent, then have the subject
complete the questionnaires
Answer:
D
- References: E6 4.5.2
- A, B, and C are incorrect: The data should not be collected until the IRB approves the revision.
- D is correct: the reference E6 4.5.2 states that the investigator should not implement any
changes without favorable approval from the IRB/IEC for a protocol amendment unless there's a
hazard to the subject. The questionnaire does not represent a hazard, so nothing should be done
without the approval of the IRB/IEC which would include an updated, approved ICF for the
amended protocol.
QUESTION
A subject is upset and wants to know whom she should contact regard- ing her rights as a
research subject. The CRC should tell her to contact the
A. PI
B. Regulatory authority
C. Risk management department
D. Individual listed on the ICF
Answer:
D
- References: E6 4.8.10 (q)
- While it might be the PI, this reference includes elements of the informed consent that should
be included. Section (q) states that the person(s) to contact for further information regarding the
trial and the rights of trial subjects, and specifically who to
contact in the event of trial-related injury, should be in included. A, B, and C are not the best
answer. The purpose of the question is to ensure the candidate knows that this is referred to in the
ICF
QUESTION
The day before a CRA is to conduct an initiation visit, the CRC realizes that the IRB.IEC
approval letter has not yet been obtained. Which of the following should the CRC do FIRST?
A. Request an expedited IRB/IEC review
B. Reschedule the initiation visit
C. Call the IRB/IEC to check the status of the letter
D. Call the sponsor to have the files checked
Answer:
, C
- References: E6 8.2.7
- A is incorrect: the stem does not indicate that the IRB/IEC had reviewed the protocol or not
- B is incorrect: The visit would only need to be rescheduled if the protocol had NOT
been reviewed
- C is correct: Any additional action needed regarding the initiation visit would come
AFTER receiving the status of the approval letter
- D is incorrect: The sponsor does not receive approval notification directly from the
IRB/IEC
QUESTION
In addition to obtaining a signed informed consent form, which of the following should be
documented in the research record?
1.The time and date of the procedures will be performed
2.That the subject's questions were answered
2.The names of people present during the consent process
4. That no trial procedures were performed prior to consenting
A. 1 and 2 only B. 1 and 3 only C. 2 and 4 only
D. 3 and 4 only
Answer:
C
- References: E6 4.8.7; E6 4.8.8
- 1 and 3 are incorrect since these are not listed in the references. 2 and 4 are correct as these are
listed I the E6 reference. E6 4.8.7 speaks to answering a subject's questions. E6 4.8.8 talks about
the ICF needing to be signed and dated by the subject (etc) prior to a subject's participation.
- C is correct since it is the only option that contains both 2 and 4
QUESTION
The CRC reviewed a new protocol to prepare the trial budget for sub- mission to the sponsor.
According to the protocol, each subject is required to return for follow-up visits at 30 days, 6
months, and 1 year. At 30 days, the protocol requires a physical exam, and electrocardiogram,
and a chest x-ray.
At 6 months, the protocol requires a physical exam, and an electrocardiogram. At 1 year, the
protocol requires a physical exam, an electrocardiogram, and
a chest x-ray. The hospital charges $75 for the physical exam, $50 for the electrocardiogram, and
$100 for the chest x-ray. The 30 day and 1 year visits are considered standard of care for the
subjects. How much should the CRC budget per subject for the non-standard of care visits?
A. $125
B. $225
, C. $450
D. $575
Answer:
A
- Math calculation: Since the 30-day and 1 year visits are considered standard of care, they are
not to be included in the budget. Required at 6 months are: physical exam ($75) and
electrocardiogram ($50) for a total of $125.
QUESTION
A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the
CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in the
diaries for the first 7 days of the trial. Upon review with the subjects, there were no related
complaints. Which of the following should be the CRC's FIRST reaction?
A. Notify the sponsor
B. Contact the manufacturer
C. Inform the remaining 20 subjects
D. Replace existing thermometers with an alternate model
Answer:
A
- References: E6 5.1.1
- A is correct: the sponsor is responsible for maintaining quality assurance and control
- B is incorrect: the sponsor would contact the manufacturer
- C is incorrect: The CRC would inform the remaining subjects if instructed to do so by the
sponsor
- D is incorrect: The sponsor is responsible for supplying the equipment for this trial
QUESTION
A subject presents at a site with her husband after pre-qualifying on a phone screen. She states
that she is legally blind and cannot rad the ICF. A Braille ICF is not available. This subject is able
to sign her own name if her hand is guided to the signature line. Which of the following is the
BEST course of action to obtain legal consent for this subject?
A. The subject and an impartial witness can sign the ICF after it is read to them and she verbally
states her understanding
B. Her husband can sign the ICF for her after it has been read to the subject and she verbally
states her understanding
C. This subject does not qualify as she is unable to read the ICF herself and a
braille consent form is not available
