CCRP Exam Guide: Certified Clinical Research Professional Preparation
                     SOCRA
CCRP
ExamName: Certified Clinical Research Professional (CCRP)
Exam Version: 6.0
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Question 1. (Single Select)
Which of the following is an example of an additional protection required when conducting research on
children?
A: There must be an impartial advocate present during the consent process
B: The investigator must obtain age-appropriate assent as determined by the IRB/IEC
C: Parents must be present during all procedures
D: The study must be approved by a central pediatric IRB
Answer: B
Explanation:
Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and how
assent is obtained, in addition to parental permission. Exact extracts:
45 CFR 46.408(a): “The IRB shall determine … whether and to what extent children are capable of
providing assent.”
ICH E6(R2) 4.8.12: “Where a subject is unable to give consent personally, assent should be obtained when
appropriate, in accordance with applicable regulatory requirement(s).”
Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not
universal requirements for all pediatric research.
ICH E6(R2) Good Clinical Practice, §4.8.12 (Informed consent/assent).
45 CFR 46 Subpart D—Additional Protections for Children, §46.408(a).
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Question 2. (Single Select)
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The
product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of
the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
A: 0
B: 1
C: 5
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D: 20
Answer: C
Explanation:
This question tests drug accountability and dosing calculation, which is central to ICH E6(R2) 4.6
(Investigational product management). Subjects must receive the correct supply and any discrepancy must
be reconciled.
The prescribed regimen is 2 mg twice daily = 4 mg per day. With 1 mg tablets, this equals 4 tablets daily.
Over 10 days, the subject should consume 40 tablets (4 × 10 = 40). Since 45 tablets were dispensed, the
subject should have 5 tablets remaining after 10 days.
Accurate accountability ensures trial integrity and subject safety. Investigators are responsible for
maintaining investigational product (IP) records, including dispensing, usage, and returns. According to
ICH:
4.6.3: “The investigator/institution should maintain records of the product’s delivery to the trial site, the
inventory, the use by each subject, and the return to the sponsor or alternative disposition.”
4.6.5: “The investigator should ensure that investigational products are used only in accordance with the
approved protocol.”
Thus, the correct answer is C (5 tablets remain). This reflects proper dosing compliance and highlights the
importance of meticulous IP tracking in clinical trials.
ICH E6(R2), §4.6 (Investigational Product(s)).
Question 3. (Single Select)
According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB
after completion of the trial at the site?
A: The final report
B: The monitoring close-out visit report
C: The data safety monitoring summary
D: The final subject enrollment log
Answer: A
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Explanation:
When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is
outlined in both ICH and CFR:
ICH E6(R2) 4.13: “Upon completion of the trial, the investigator should provide the IRB/IEC with a summary
of the trial’s outcome.”
21 CFR 312.66: Requires investigators to “report to the IRB all changes in the research activity and all
unanticipated problems involving risk, and to provide reports at the end of the study.”
The final report provides closure and documentation that the study was conducted ethically and in
compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB
summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB
submission.
Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study
completion, outcome, and compliance with ethical oversight.
ICH E6(R2), §4.13 (Final reporting to IRB/IEC).
21 CFR 312.66 (IRB review and reporting).
Question 4. (Single Select)
In determining the classification of risk for a study involving a medical device, it is necessary to consider
the:
A: Number of patients to be treated with the device
B: Cost of device
C: Investigators’ prior training and experience
D: Use of the device in the particular study
Answer: D
Explanation:
FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines
whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is
how the device will be used in the specific study.
21 CFR 812.3(m): Defines a “significant risk device study” as one that “is intended as an implant, is
purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a
potential for serious risk to the health, safety, or welfare of a subject.”
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Risk is judged within the context of the protocol — i.e., use of the device in that particular study (D).
Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA’s risk
classification. For example, a stent used in an approved indication may be NSR, but if used in a new
anatomical location, it may be SR.
Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the
intended clinical context rather than device attributes alone.
21 CFR 812.3(m) (Definition of significant risk device).
FDA Guidance on Significant Risk and Nonsignificant Risk Medical Device Studies.
Question 5. (Single Select)
A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after
one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional
institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in
the regulatory binder?
A: The letter documenting the promotion to a CRC
B: A brochure from the training course
C: An updated performance review summary
D: An updated curriculum vitae
Answer: D
Explanation:
The regulatory binder (investigator site file) must contain documents verifying qualifications of all personnel.
These include curricula vitae (CVs), professional licenses, and training certificates.
ICH E6(R2) 4.1.5: “The investigator should ensure that all persons assisting with the trial are qualified by
education, training, and experience… Current curriculum vitae and/or other relevant documents evidencing
qualifications should be maintained.”
21 CFR 312.53(c)(1): Sponsors must select investigators qualified “by training and experience,” and
investigators must provide sufficient documentation, typically updated CVs.
Letters of promotion (A), training brochures (B), or performance reviews (C) may remain in personnel files
but are not required regulatory documents. The only acceptable regulatory proof is an updated CV (D),
which reflects the individual’s training and qualifications for their new role.
Therefore, the correct answer is D (Updated CV). This ensures compliance with ICH and FDA
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requirements for staff qualification documentation in clinical research.
ICH E6(R2) Good Clinical Practice, §4.1.5 (Investigator responsibilities for staff qualification).
21 CFR 312.53(c)(1) (Investigator qualifications and documentation).
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