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CCRP최신버전시험대비공부문제인증시험정보

참고: DumpTOP에서 Google Drive로 공유하는 무료, 최신 CCRP 시험 문제집이 있습니다: https://drive.google.com/open?id=1J7Y8-B7-zGY7b9FbpLkO9Sh-WBPT1U7R

DumpTOP의SOCRA인증 CCRP덤프공부가이드에는SOCRA인증 CCRP시험의 가장 최신 시험문제의 기출문제와 예상문제가 정리되어 있어SOCRA인증 CCRP시험을 패스하는데 좋은 동반자로 되어드립니다. SOCRA인증 CCRP시험에서 떨어지는 경우SOCRA인증 CCRP덤프비용전액 환불신청을 할수 있기에 보장성이 있습니다.시험적중율이 떨어지는 경우 덤프를 빌려 공부한 것과 같기에 부담없이 덤프를 구매하셔도 됩니다.

SOCRA CCRP 시험요강:

주제
소개

주제 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.

주제 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.

 

>> CCRP최신버전 시험대비 공부문제 <<

높은 통과율 CCRP최신버전 시험대비 공부문제 시험대비자료

우리의 덤프는 기존의 시험문제와 답과 시험문제분석 등입니다. DumpTOP에서 제공하는SOCRA CCRP시험자료의 문제와 답은 실제시험의 문제와 답과 아주 비슷합니다. DumpTOP는 여러분이 한번에SOCRA CCRP인증시험을 패스함을 보장 드립니다.

최신 Clinical Research Professional CCRP 무료샘플문제 (Q83-Q88):

질문 # 83
After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?

• A. The sponsor
• B. The investigator
• C. The study coordinator
• D. The IRB/IEC

정답：A

설명：
Monitoring reports are sponsor-controlled documents.
* ICH E6(R2) 5.18.6:"The monitor should submit a written report to the sponsor after each trial-site visit... The sponsor should review and follow up on the monitoring report."
* ICH E6(R2) 8.1 & 8.2.22:Monitoring visit reports are essential documents maintained by the sponsor.
Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.
Thus, the correct answer isB (The sponsor).
References:
ICH E6(R2), §5.18.6 (Monitoring reports).
ICH E6(R2), §8.2.22 (Essential documents: monitoring visit reports).

 

질문 # 84
Which of the following is one of the responsibilities of an investigator?

• A. Updating the investigator brochure with new safety information
• B. Selecting qualified monitors on the basis of training, experience, and expertise
• C. Maintaining accurate and current case histories of study subjects
• D. Participating in the IRB/IEC voting process for approval of their protocol

정답：C

설명：
Investigators are required to maintain accurate subject records, often referred to ascase histories.
* 21 CFR 312.62(b):"An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation."
* ICH E6(R2) 4.9.0:Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.
Incorrect options:
* B: Investigators may present protocols but cannot vote on IRB approval.
* C: Sponsor responsibility (ICH E6 §5.18).
* D: Sponsors are responsible for IB updates (ICH E6 §7.3.1).
Correct answer:A.
References:
21 CFR 312.62(b).
ICH E6(R2), §4.9.0.

 

질문 # 85
An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?

• A. No notification is required
• B. The Data Safety Monitoring Board (DSMB)
• C. The regulatory authority
• D. The IRB/IEC

정답：A

설명：
TheInvestigator's Brochure (IB)is updated by the sponsor to reflect new scientific or clinical information.
* ICH E6(R2) 7.3:"The sponsor should revise the IB as soon as new, significant information becomes available."
* ICH E6(R2) 4.1.5:Requires the investigator to ensure staff are informed, but there isno requirementto notify IRB/IEC unless subject safety, rights, or risk profile is affected.
Since this update containedno changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in theregulatory binderand implemented at the site.
Thus, the correct answer isD (No notification is required).
References:
ICH E6(R2), §7.3 (Updating the Investigator's Brochure).
ICH E6(R2), §4.1.5 (Investigator responsibilities for informing staff).

 

질문 # 86
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties andfunctions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?

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

정답：A

설명：
Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:
* ICH E6(R2) 5.2.1: "A sponsor may transfer any or all of the sponsor's trial-related duties... to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor."Hence, D is correct.
References:
ICH E6(R2) Good Clinical Practice, §5.2.1 (Sponsor/CRO).===========

 

질문 # 87
On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?

• A. 15 May 2034
• B. 16 May 2021
• C. 15 May 2022
• D. 16 May 2022

정답：D

설명：
Record retention requirements ensure regulatory access to data even after development is discontinued.
* 21 CFR 312.62(c):"An investigator shall retain records... for2 years after the date a marketing application is withdrawn or discontinuedand FDA is notified."
* In this case, development was terminated15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is15 May 2021, but FDA requires records to be maintaineduntil after the 2-year period ends. Theearliest permissible destruction date is 16 May 2022 (C).
Options A and B are premature; D (2034) is far beyond requirements.
Thus, the correct answer isC (16 May 2022).
References:
21 CFR 312.62(c) (Investigator record retention).
21 CFR 312.57(c) (Sponsor record retention).

 

질문 # 88
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