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CCRP Exam Tutorials | CCRP Examcollection Dumps Torrent
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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q44-Q49):
NEW QUESTION # 44
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties andfunctions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?
- A. The CRO
- B. The investigator
- C. The IRB/IEC
- D. The sponsor
Answer: D
Explanation:
Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:
* ICH E6(R2) 5.2.1: "A sponsor may transfer any or all of the sponsor's trial-related duties... to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor."Hence, D is correct.
References:
ICH E6(R2) Good Clinical Practice, §5.2.1 (Sponsor/CRO).===========
NEW QUESTION # 45
A company's CEO wants to commercially promote a device under an IDE study. This plan:
- A. Requires IDE approval
- B. Requires IRB/IEC approval
- C. Requires a large advertising budget
- D. Would violate FDA regulations
Answer: D
Explanation:
* 21 CFR 812.7:Prohibits promotion of investigational devices or claiming safety/effectiveness until FDA approval is granted.
* Investigational devices may only be used in clinical trials, not marketed.
Thus, promotion during an IDE study is anFDA violation.
References:21 CFR 812.7.
NEW QUESTION # 46
In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?
- A. Institution
- B. Sponsor
- C. Regulatory authority
- D. Investigator
Answer: B
Explanation:
* ICH E6(R2) 5.5.3:Sponsors are responsible for validating computerized systems used in trials.
Investigators ensure proper data entry, but system compliance lies with sponsor.
References:ICH E6(R2), §5.5.3.
NEW QUESTION # 47
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?
- A. Every 4-6 weeks until study close-out
- B. Once a year until study close-out
- C. In a timely manner before, during, and after the study
- D. At least weekly
Answer: C
Explanation:
Monitoring ensures trial integrity and subject safety.
* ICH E6(R2) 5.18.3:"The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial."
* Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).
It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible, but must cover all phases of the study.
Correct answer:C (Timely manner before, during, and after).
References:
ICH E6(R2), §5.18.3.
NEW QUESTION # 48
An investigator's responsibilities for conducting clinical trials include:
- A. Maintaining IRB meeting minutes
- B. Observing preclinical drug effects
- C. Administering or overseeing investigational drug administration
- D. Maintaining financial documentation for study staff
Answer: C
Explanation:
* ICH E6(R2) 4.6.1:The investigator is responsible for investigational product accountability at the site.
* 21 CFR 312.61:Investigators must administer the investigational drug only to subjects under their supervision.
The IRB maintains meeting minutes (A), preclinical studies are sponsor tasks (B), and financial interest documentation (C) is covered under sponsor reporting. Thus,D is correct.
References:ICH E6(R2) §4.6.1; 21 CFR 312.61.
NEW QUESTION # 49
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