SOCRA Certified Clinical Research Professional CCRP Exam Questions

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Total 130 questions
Question 1

A clinical investigator wants to publish a subject's unique results. The consent form did not mention publication. What is required?



Answer : B

ICH E6(R2) 4.8.10(n): Consent must include explanation about confidentiality and possible publication.

If not included, specific subject consent must be obtained before publishing identifiable results.

Thus, subject's explicit permission is required.


Question 2

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 3

While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?



Answer : B

Providing a copy of the signed consent form to subjects is a mandatory requirement.

21 CFR 50.27(a): ''A copy shall be given to the person signing the form.''

ICH E6(R2) 4.8.11: Reinforces that ''a copy of the signed and dated written informed consent form should be given to the subject.''

Failure to provide this copy constitutes a direct violation of informed consent regulations.

Other issues:

A & C concern proper short form process but do not invalidate informed consent if a copy was provided.

D concerns sponsor template, but the site's responsibility is ensuring use of IRB-approved version.

Correct answer: B.


21 CFR 50.27(a).

ICH E6(R2), 4.8.11.

Question 4

Protecting prisoners' rights to voluntarily participate in research is an example of which Belmont principle?



Answer : D

Belmont Report: ''Respect for Persons'' incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).

Prisoners require special safeguards because of restricted liberty and potential coercion.


Question 5

An investigator reports a serious adverse event suspected to be drug-related. By CFR, the sponsor must notify FDA no later than:



Answer : B

21 CFR 312.32(c)(2): Life-threatening or fatal unexpected adverse events must be reported within 7 calendar days.

Other serious unexpected events are reported within 15 days.


Question 6

An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?



Answer : A

21 CFR 54.4(b): Requires disclosure during the study and for 1 year after completion.

After three years, no disclosure is required.


Question 7

A sponsor is permitted to charge for an investigational drug but must provide what documentation?



Answer : D

21 CFR 312.8(b): Sponsors may charge for investigational drugs only if they demonstrate that the drug provides potential clinical benefit and a significant advantage over existing therapy.

FDA must approve charging requests.


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Total 130 questions