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[Hardware] Sample CCRP Test Online | Pass CCRP Test Guide

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【Hardware】 Sample CCRP Test Online | Pass CCRP Test Guide

Posted at yesterday 21:32      View：21 | 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 (Q94-Q99):NEW QUESTION # 94
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?
  • A. The completed subject identification code list
  • B. The final trial closeout monitoring report
  • C. The audit certificate
  • D. The master randomization list
Answer: A
Explanation:
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.
* ICH E6(R2) 8.3.21:"Subject Identification Code List - A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period."
* ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer isB (Completed Subject Identification Code List).
References:
ICH E6(R2), §8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), §8.4 (Essential documents for trial closure).

NEW QUESTION # 95
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; the witness
  • B. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness
  • C. The subject or else the subject's legally authorized representative
  • D. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee
Answer: A
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 # 96
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
  • A. Every year
  • B. Exactly one time, at study closure
  • C. Every two years
  • D. There is no such requirement
Answer: D
Explanation:
Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).
* 45 CFR 46.109(f):"Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk."
* ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.
Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.
Thus, the correct answer isD (No such requirement).
References:
45 CFR 46.109(f) (Exempt and expedited reviews).

NEW QUESTION # 97
In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?
  • A. At least 15 years
  • B. Until the regulatory authority has approved the investigational product for use
  • C. Indefinitely
  • D. At least 3 years
Answer: D
Explanation:
IRBs/IECs must retain records to permit evaluation of compliance.
* ICH E6(R2) 3.4.2:"IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least3 years after completion of the trial." Extended retention (B-D) may occur institutionally, but ICH minimum is3 years.
Correct answer:A (At least 3 years).
References:
ICH E6(R2), §3.4.2.

NEW QUESTION # 98
A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?
  • A. >$25,000
  • B. Any amount
  • C. $5,000
  • D. $10,000
Answer: D
Explanation:
* 21 CFR 54.2(f) & 54.4(a):Requires disclosure of "significant payments of other sorts" (SPOOS) that exceed$25,000or equity interests exceeding$50,000.
* However,honoraria or consulting exceeding $10,000 annuallyalso trigger disclosure.
Thus, the reporting threshold is$10,000.
References:21 CFR 54.2(f), 54.4(a).

NEW QUESTION # 99
......
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