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[General] CCRP Valid Test Sims & Reliable CCRP Test Preparation

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【General】 CCRP Valid Test Sims & Reliable CCRP Test Preparation

Posted at yesterday 17:42      View：18 | Replies：1        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.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q17-Q22):NEW QUESTION # 17
A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?
  • A. Clinical investigator
  • B. Program manager
  • C. IRB/IEC
  • D. Sponsor
Answer: A
Explanation:
* ICH E6(R2) 4.2.4:"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties."This responsibility cannot be delegated to sponsor or IRB.
References:ICH E6(R2), §4.2.4.

NEW QUESTION # 18
Upon completion of a study, the investigator should do which of the following?
  • A. Provide the IRB/IEC a final report, but only if the study has a positive outcome
  • B. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome
  • C. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
  • D. Ensure that all payments from sponsor have been received
Answer: B
Explanation:
Investigators must formally close out a trial with the IRB/IEC.
* ICH E6(R2) 4.13.2:"Upon completion of the trial, the investigator/institution should provide the IRB
/IEC with a summary of the trial's outcome."
* 21 CFR 312.66:Reinforces investigator's duty to keep IRB informed throughout study lifecycle.
This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).
Thus, the correct answer isA (Provide final report to IRB/IEC).
References:
ICH E6(R2), §4.13.2 (Final reporting requirement).

NEW QUESTION # 19
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?
  • A. Overseeing the administration of the investigational drug to the subjects
  • B. Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
  • C. Maintaining case histories that record all observations and other data pertinent to the investigation
  • D. Submitting progress reports to the reviewing IRB/IEC
Answer: B
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 # 20
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 electronic medical record
  • B. The EDC record
  • C. A printout of the electronic medical record
  • D. A printout of the EDC record
Answer: B
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 # 21
The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?
  • A. To submit this safety update to the regulatory authority
  • B. To discontinue the subject's study drug
  • C. To provide the subject with information regarding the significant new findings
  • D. To give the subject's contact information to the sponsor in order to allow the sponsor to contact the subject
Answer: C
Explanation:
Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.
* ICH E6(R2) 4.8.2:"If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner."
* 21 CFR 50.25(b)(5):Consent must include a statement that "significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided." Thus, the investigator mustcommunicate new risk information to the subject.
Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.
Correct answer:C.
References:
ICH E6(R2), §4.8.2.
21 CFR 50.25(b)(5).

NEW QUESTION # 22
......
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Posted at yesterday 17:56        Only Author  2#
This article has given me a lot of space for reflection, and I’ve gained a lot. Sending positive vibes for the Valid DevOps-Foundation exam question exam – wish me luck!
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