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Valid CCRP pdf vce & SOCRA CCRP test answers & CCRP troytec exams
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SOCRA CCRP Exam Syllabus Topics:
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SOCRA CCRP Exam Questions Vce, CCRP Reliable Exam Price
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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q67-Q72):
NEW QUESTION # 67
An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?
- A. Report to sponsor
- B. Report to FDA
- C. Report to OHRP
- D. None
Answer: D
Explanation:
* 21 CFR 54.4(b):Requires disclosureduring the study and for 1 year after completion.
* After three years, no disclosure is required.
References:21 CFR 54.4(b).
NEW QUESTION # 68
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?
- A. It does not identify some of the applicable mandated basic elements
- B. It identifies all of the applicable mandated basic elements
- C. It is signed and dated by the subject's legally authorized representative
- D. It is signed and dated by the IRB/IEC chair
Answer: B
Explanation:
The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
* 21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
* ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D).
Options A and B confuse who signs-subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer:D.
References:
21 CFR 50.25(a).
ICH E6(R2), §4.8.10.
NEW QUESTION # 69
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
- A. The reviewing IRB/IEC
- B. A data safety monitoring board
- C. The medical monitor
- D. The clinical investigator
Answer: A
Explanation:
Minimal risk determination is a regulatory function of the IRB/IEC.
* 45 CFR 46.102(j):Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.
* 45 CFR 46.109(a):The IRB has authority to approve, require modifications, or disapprove research, including assessment ofrisk level.
* Investigators may propose a study as minimal risk, but only theIRB/IEC can formally classify it.
This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.
References:45 CFR 46.102(j), 46.109(a).
NEW QUESTION # 70
An investigator reports a serious adverse event suspected to be drug-related. By CFR, the sponsor must notify FDA no later than:
- A. 15 days
- B. 10 days
- C. 7 days
- D. 1 day
Answer: C
Explanation:
* 21 CFR 312.32(c)(2):Life-threatening or fatal unexpected adverse events must be reported within7 calendar days.Other serious unexpected events are reported within 15 days.
References:21 CFR 312.32(c)(2).
NEW QUESTION # 71
According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?
- A. The subject or else the subject's legally authorized representative
- B. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee
- C. The subject or else the subject's legally authorized representative; the witness
- D. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness
Answer: C
Explanation:
Theshort form consent processis permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.
* 21 CFR 50.27(b)(2):Requires the short form to be signed by the subject (or legally authorized representative)and a witness.
* The witness ensures that oral consent was properly conveyed and understood.
* The person obtaining consent must sign aseparate written summary, but not the short form itself.
Thus, the accurate answer isA: subject (or LAR) + witness.
References:
21 CFR 50.27(b)(2).
NEW QUESTION # 72
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