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Latest SOCRA CCRP Exam Question, Authorized CCRP Exam Dumps

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Latest SOCRA CCRP Exam Question, Authorized CCRP Exam Dumps

Posted at 11 hour before      View：15 | Replies：0        Print      Only Author   [Copy Link] 1#
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SOCRA CCRP Exam Syllabus Topics:
TopicDetails
Topic 1
  • Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.|Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.
Topic 2
  • Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q25-Q30):NEW QUESTION # 25
Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?
  • A. A plan for the publication of study results is in place
  • B. The investigator has adequate access to patients eligible for the trial
  • C. The selection of subjects is equitable
  • D. The sponsor is qualified to provide oversight of the trial
Answer: C
Explanation:
IRB/IEC review focuses onethical protection of human subjects. Equitable subject selection is a cornerstone principle.
* 45 CFR 46.111(a)(3):"In order to approve research... the IRB shall determine that:Selection of subjects is equitable."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects... with particular attention to trials that may include vulnerable subjects." Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB's role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.
Thus, the correct answer isB (The selection of subjects is equitable).
References:
45 CFR 46.111(a)(3) (Equitable subject selection).
ICH E6(R2), §3.1.2 (IRB/IEC role).

NEW QUESTION # 26
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:
  • A. Maintain accurate records throughout retention
  • B. Generate audit trails
  • C. Customize access rights
  • D. Print a complete paper copy
Answer: D
Explanation:
* 21 CFR 11.10:Requires validation, audit trails, secure access, but does not mandate printing capability.
Thus, (D) is the exception.
References:21 CFR 11.10.

NEW QUESTION # 27
An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?
  • A. Report to FDA
  • B. Report to sponsor
  • C. None
  • D. Report to OHRP
Answer: C
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 # 28
An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
  • A. OHRP
  • B. Research pharmacist
  • C. FDA
  • D. Sponsor
Answer: D
Explanation:
* 21 CFR 812.150(a)(1):Investigators must report unanticipated adverse device effects to thesponsor within 10 working days.
* Sponsor is then responsible for notifying FDA and all investigators.
References:21 CFR 812.150(a)(1).

NEW QUESTION # 29
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. The EDC record
  • B. A printout of the electronic medical record
  • C. A printout of the EDC record
  • D. The electronic medical record
Answer: A
Explanation:
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51efines 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 # 30
......
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