CCRP PDF Cram Exam - CCRP Download Demo

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q55-Q60):

NEW QUESTION # 55
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?

Answer: A

Explanation:
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51:Defines source data as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial." Since subjects directly enter responses into the EDC, theEDC record itself is the original source document.
EMRs (B, C) and printouts (D) are secondary records.
Correct answer:A (The EDC record).
References:
ICH E6(R2), §1.51 (Definition of source data).


NEW QUESTION # 56
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?

Answer: D

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.
References:
ICH E6(R2), §4.13 (Final reporting to IRB/IEC).
21 CFR 312.66 (IRB review and reporting).


NEW QUESTION # 57
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

Answer: D

Explanation:
Sponsors are responsible for distributing safety updates across all investigators and the FDA.
* 21 CFR 312.55(b):"The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug." Other responsibilities fall elsewhere:
* Case histories (C) are maintained by investigators (21 CFR 312.62(b)).
* Progress reports to IRBs (D) are the investigator's duty (21 CFR 312.66).
* Administration of investigational drug (A) is managed by the investigator at site level.
Thus, the correct answer isB (Ensuring FDA and investigators are promptly informed).
References:
21 CFR 312.55(b) (Sponsor notification requirements).


NEW QUESTION # 58
Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?

Answer: D

Explanation:
AnInvestigational New Drug (IND) applicationprovides FDA with data to justify human testing.
* 21 CFR 312.23(a)(3):The IND must contain "a description of the general investigational plan, including the rationale for the drug or the research study."
* The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.
Financial disclosures (D) are reported separately under21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.
Thus, the correct answer isB (Rationale and plan for human testing).
References:
21 CFR 312.23(a)(3) (IND contents).
21 CFR 312.20 (General IND requirements).


NEW QUESTION # 59
In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:

Answer: B

Explanation:
21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.
* 21 CFR 11.10(a):Requires "validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."
* Validated systems ensure equivalency between electronic and paper records.
While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.
Thus, the correct answer isB (Managed within a validated computer system).
References:
21 CFR 11.10(a) (System validation requirement).


NEW QUESTION # 60
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