CRC Certification Exam 2026: Comprehensive Clinical Research
Coordinator Practice Test — Study Start-Up, Research Ethics,
Regulatory Compliance, Participant Safety, Data Management &
Study Closeout — 190 Multiple-Choice Questions with Answers &
Detailed Rationales
Domain I: Scientific Concepts and Research Design (Questions 1-25)
Question 1
A Phase II oncology trial is designed with a primary endpoint of objective response rate and
a secondary endpoint of progression-free survival. The coordinator notices that the protocol
specifies tumor assessments every 8 weeks, but the standard of care at the site performs
imaging every 12 weeks. What is the coordinator's most appropriate action?
A. Follow the protocol schedule and document any deviations from standard of care
B. Follow the standard of care schedule since it is more convenient for patients
C. Ask the principal investigator to amend the protocol to match standard of care
D. Consult with the sponsor about modifying the assessment schedule
Correct Answer: A
Explanation: Protocol compliance requires following the specified assessment schedule;
deviations from standard of care are documented as protocol-required procedures. The
protocol is the governing document for all study procedures.
Question 2
A sponsor provides a draft protocol for a first-in-human study of a novel monoclonal
antibody. The coordinator is asked to evaluate site feasibility. Which factor is most critical for
this assessment?
A. The site's experience with the therapeutic area
,B. The availability of appropriate safety monitoring and rescue equipment
C. The site's historical enrollment rate for similar studies
D. The proximity of the site to the sponsor's headquarters
Correct Answer: B
Explanation: First-in-human studies carry unknown safety risks; sites must have appropriate
emergency equipment and trained personnel to manage potential severe reactions.
Question 3
During a site initiation visit, the monitor explains that the study uses a 2:1 randomization
ratio (active:placebo). The coordinator understands this means:
A. Two participants will receive active drug for every one receiving placebo
B. One participant will receive active drug for every two receiving placebo
C. Participants will be randomized in blocks of two
D. Two sites will enroll for every one site that does not
Correct Answer: A
Explanation: A 2:1 randomization ratio means for every three participants, two receive active
treatment and one receives placebo; this design increases exposure to active drug for safety
data.
Question 4
A protocol specifies that the investigational product must be stored at -20°C. The pharmacy
freezer's temperature monitoring log shows a 4-hour period where the temperature rose to
-10°C. What should the coordinator do FIRST?
A. Discard the affected investigational product immediately
,B. Quarantine the product and notify the sponsor and monitor
C. Continue using the product since the excursion was brief
D. Document the deviation and continue normal operations
Correct Answer: B
Explanation: Temperature excursions require quarantine of affected product and immediate
notification to sponsor; stability data must be reviewed before determining product viability.
Question 5
A coordinator is reviewing a protocol for a medical device study. The investigational device is
described as "non-significant risk." What does this classification mean for the site?
A. The study qualifies for abbreviated investigational device exemption requirements
B. The device is exempt from all regulatory oversight
C. The IRB must still approve the study but may use an expedited review process
D. The device can be used without informed consent
Correct Answer: A
Explanation: Non-significant risk device studies are exempt from the full IDE requirements
but still require IRB approval; the sponsor makes the initial risk determination.
Question 6
In a crossover trial design, what is the PRIMARY advantage that the coordinator should
understand?
A. It eliminates the need for a control group
B. Each participant serves as their own control, reducing variability
, C. It requires fewer participants than parallel designs
D. It eliminates the possibility of carryover effects
Correct Answer: B
Explanation: Crossover designs allow each participant to receive both treatments, reducing
inter-subject variability and increasing statistical power, though carryover effects must be
managed.
Question 7
A protocol amendment is submitted to the IRB that changes the primary endpoint from
overall survival to progression-free survival. The coordinator should recognize this as:
A. A minor administrative change requiring only notification
B. A substantial change requiring full IRB review before implementation
C. A change that only requires sponsor approval
D. A change that can be implemented immediately
Correct Answer: B
Explanation: Changes to primary endpoints are substantial modifications affecting risk-
benefit analysis and require IRB approval before implementation, except to eliminate
immediate hazards.
Question 8
During review of an Investigator's Brochure, the coordinator notes that the investigational
product has been associated with QT prolongation in preclinical studies. What is the most
important implication for study conduct?
A. Participants must undergo baseline and on-treatment ECG monitoring
Coordinator Practice Test — Study Start-Up, Research Ethics,
Regulatory Compliance, Participant Safety, Data Management &
Study Closeout — 190 Multiple-Choice Questions with Answers &
Detailed Rationales
Domain I: Scientific Concepts and Research Design (Questions 1-25)
Question 1
A Phase II oncology trial is designed with a primary endpoint of objective response rate and
a secondary endpoint of progression-free survival. The coordinator notices that the protocol
specifies tumor assessments every 8 weeks, but the standard of care at the site performs
imaging every 12 weeks. What is the coordinator's most appropriate action?
A. Follow the protocol schedule and document any deviations from standard of care
B. Follow the standard of care schedule since it is more convenient for patients
C. Ask the principal investigator to amend the protocol to match standard of care
D. Consult with the sponsor about modifying the assessment schedule
Correct Answer: A
Explanation: Protocol compliance requires following the specified assessment schedule;
deviations from standard of care are documented as protocol-required procedures. The
protocol is the governing document for all study procedures.
Question 2
A sponsor provides a draft protocol for a first-in-human study of a novel monoclonal
antibody. The coordinator is asked to evaluate site feasibility. Which factor is most critical for
this assessment?
A. The site's experience with the therapeutic area
,B. The availability of appropriate safety monitoring and rescue equipment
C. The site's historical enrollment rate for similar studies
D. The proximity of the site to the sponsor's headquarters
Correct Answer: B
Explanation: First-in-human studies carry unknown safety risks; sites must have appropriate
emergency equipment and trained personnel to manage potential severe reactions.
Question 3
During a site initiation visit, the monitor explains that the study uses a 2:1 randomization
ratio (active:placebo). The coordinator understands this means:
A. Two participants will receive active drug for every one receiving placebo
B. One participant will receive active drug for every two receiving placebo
C. Participants will be randomized in blocks of two
D. Two sites will enroll for every one site that does not
Correct Answer: A
Explanation: A 2:1 randomization ratio means for every three participants, two receive active
treatment and one receives placebo; this design increases exposure to active drug for safety
data.
Question 4
A protocol specifies that the investigational product must be stored at -20°C. The pharmacy
freezer's temperature monitoring log shows a 4-hour period where the temperature rose to
-10°C. What should the coordinator do FIRST?
A. Discard the affected investigational product immediately
,B. Quarantine the product and notify the sponsor and monitor
C. Continue using the product since the excursion was brief
D. Document the deviation and continue normal operations
Correct Answer: B
Explanation: Temperature excursions require quarantine of affected product and immediate
notification to sponsor; stability data must be reviewed before determining product viability.
Question 5
A coordinator is reviewing a protocol for a medical device study. The investigational device is
described as "non-significant risk." What does this classification mean for the site?
A. The study qualifies for abbreviated investigational device exemption requirements
B. The device is exempt from all regulatory oversight
C. The IRB must still approve the study but may use an expedited review process
D. The device can be used without informed consent
Correct Answer: A
Explanation: Non-significant risk device studies are exempt from the full IDE requirements
but still require IRB approval; the sponsor makes the initial risk determination.
Question 6
In a crossover trial design, what is the PRIMARY advantage that the coordinator should
understand?
A. It eliminates the need for a control group
B. Each participant serves as their own control, reducing variability
, C. It requires fewer participants than parallel designs
D. It eliminates the possibility of carryover effects
Correct Answer: B
Explanation: Crossover designs allow each participant to receive both treatments, reducing
inter-subject variability and increasing statistical power, though carryover effects must be
managed.
Question 7
A protocol amendment is submitted to the IRB that changes the primary endpoint from
overall survival to progression-free survival. The coordinator should recognize this as:
A. A minor administrative change requiring only notification
B. A substantial change requiring full IRB review before implementation
C. A change that only requires sponsor approval
D. A change that can be implemented immediately
Correct Answer: B
Explanation: Changes to primary endpoints are substantial modifications affecting risk-
benefit analysis and require IRB approval before implementation, except to eliminate
immediate hazards.
Question 8
During review of an Investigator's Brochure, the coordinator notes that the investigational
product has been associated with QT prolongation in preclinical studies. What is the most
important implication for study conduct?
A. Participants must undergo baseline and on-treatment ECG monitoring
