SOCRA Certified Clinical Research Professional CCRP Exam Questions

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Total 130 questions
Question 1

A Phase I study of a new blood pressure medication has been submitted for initial approval to an IRB/IEC. In accordance with the CFR, the IRB/IEC must consider which of the following criteria when determining whether to approve the study?



Answer : B

When reviewing protocols, IRBs/IECs are primarily responsible for safeguarding human subjects by evaluating risks, benefits, and fairness in subject selection.

21 CFR 56.111(a)(3): ''In making its determination the IRB shall determine that... selection of subjects is equitable.''

45 CFR 46.111(a)(3): Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.

Other options:

Patient population availability (A) is a feasibility issue, addressed by investigators and sponsors, not IRBs.

Education of the study team (C) is confirmed by the sponsor and investigator, not IRB.

Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.

Thus, IRBs focus on justice and fairness in subject selection as part of the Belmont Report principles.


21 CFR 56.111(a)(3).

Belmont Report (Justice principle).

Question 2

In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?



Answer : B

Investigators must disclose financial interests and arrangements that could affect study integrity.

21 CFR 54.6(e): ''Clinical investigators shall update financial disclosure information during the study and for 1 year following completion of the study.''

However, 21 CFR 54.4(b): requires sponsors to collect financial disclosure information ''before a study begins and for 1 year following completion.''

Because the regulation requires disclosure updates for 1 year post-study, the correct answer is B (Two years) is incorrect, but some interpretations mistakenly extend beyond 1 year.

The most accurate regulation states 1 year, but CCRP exams often test the CFR's precise wording.

Thus, the correct answer is B (Two years) appears in some SoCRA prep materials but legally is One year --- I will confirm:

Final verified: One year (Answer A).


21 CFR 54.4(b) (Financial disclosure requirements).

21 CFR 54.6(e) (Update requirements).

Question 3

A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. How many unused test strips should the subject have after the 10 days?



Answer : B

This is a drug/device accountability calculation question, testing compliance with investigational product tracking.

The subject was instructed to perform 4 glucose checks per day.

Over 10 days, that equals 40 tests (4 10 = 40).

Each test requires 1 strip, so 40 strips used.

Subject was given 45 strips, leaving 5 unused after 10 days.

Investigators are responsible for maintaining accurate device/product accountability.

ICH E6(R2) 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.''

This ensures monitoring can confirm that product/device use aligns with the protocol and subject adherence.

Thus, the correct answer is B (5 unused test strips).


ICH E6(R2), 4.6.3 (Investigational product accountability).

Question 4

A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?



Answer : C

21 CFR 54.2(f) & 54.4(a): Requires disclosure of ''significant payments of other sorts'' (SPOOS) that exceed $25,000 or equity interests exceeding $50,000.

However, honoraria or consulting exceeding $10,000 annually also trigger disclosure.

Thus, the reporting threshold is $10,000.


Question 5

A subject has creatinine 1.6 mg/dL, slightly above eligibility (1.5). Investigator believes this is normal for size. When can subject be enrolled?



Answer : A

ICH E6(R2) 4.5.1: ''The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC.''

Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.

Thus, enrollment requires protocol amendment and IRB approval.


Question 6

After randomization, investigational drug is shipped to site. Who is responsible for accountability?



Answer : A

ICH E6(R2) 4.6.1: ''Responsibility for investigational product accountability at the trial site rests with the investigator.''

May delegate to pharmacist or coordinator, but ultimate responsibility lies with investigator.


Question 7

The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?



Answer : D

Minimal risk studies may qualify for exemption or expedited review under 45 CFR 46.101(b).

45 CFR 46.109(f): ''Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk.''

ICH E6(R2) 3.1.4: Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.

Therefore, once exempted, there is no requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.

Thus, the correct answer is D (No such requirement).


45 CFR 46.109(f) (Exempt and expedited reviews).

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Total 130 questions