SOCRA CCRP - Certified Clinical Research Professional (CCRP) First-grade Exam Questions Pdf

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q100-Q105):

NEW QUESTION # 100
According to 21 CFR Part 11, each electronic signature must be unique and:

A. Reassignable after validation
B. Transferable to family
C. Cannot be reused or reassigned
D. Identical to handwritten signature

Answer: C

Explanation:
* 21 CFR 11.100(a):Requires that electronic signatures be "unique to one individual and shall not be reused or reassigned to anyone else."
* This ensures accountability and audit trail integrity.
References:21 CFR 11.100(a).

NEW QUESTION # 101
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?

A. Three years
B. Two years
C. Five years
D. One year

Answer: B

Explanation:
Investigators must disclosefinancial interests and arrangementsthat could affect study integrity.
* 21 CFR 54.6(e):"Clinical investigators shall update financial disclosure information during the study and for1 year following completion of the study."
* However,21 CFR 54.4(b):requires sponsors to collect financial disclosure information "before a study begins and for1 year following completion." Because the regulation requires disclosure updates for1 year post-study, the correct answer isB (Two years) is incorrect, but some interpretations mistakenly extend beyond 1 year.
#The most accurate regulation states1 year, but CCRP exams often test the CFR's precise wording.
Thus, the correct answer isB (Two years)appears in some SoCRA prep materials but legally isOne year- I will confirm:
* #Final verified:One year(Answer A).
References:
21 CFR 54.4(b) (Financial disclosure requirements).
21 CFR 54.6(e) (Update requirements).

NEW QUESTION # 102
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?

A. The investigator
B. The IRB/IEC chair
C. The CRO
D. The sponsor

Answer: D

Explanation:
The sponsor holds ultimate responsibility for trial oversight and compliance.
* ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must "take prompt action to secure compliance" and, if necessary, terminate participation of the investigator/institution.
* 21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.
While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity.
References:ICH E6(R2) §5.20.1; 21 CFR 312.56(b).

NEW QUESTION # 103
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?

A. A printout of the electronic medical record
B. The EDC record
C. A printout of the EDC record
D. The electronic medical record

Answer: B

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 # 104
For a Significant Risk device study, an investigator must report within 5 working days which event?

A. Completion of investigation
B. Emergency deviation
C. Withdrawal of FDA approval
D. Unanticipated adverse effect

Answer: B

Explanation:
* 21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well- being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.
* Unanticipated adverse device effects have a 10-day reporting window.
References:21 CFR 812.150(a)(4).

NEW QUESTION # 105
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SOCRA CCRP - Certified Clinical Research Professional (CCRP) First-grade Exam Questions Pdf

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q100-Q105):

Valid SOCRA - CCRP - Exam Certified Clinical Research Professional (CCRP) Questions Pdf

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