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[General] Stay Updated with the Latest Online Practice SOCRA CCRP Test Engine

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【General】 Stay Updated with the Latest Online Practice SOCRA CCRP Test Engine

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SOCRA CCRP Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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.
Topic 2
  • 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.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q25-Q30):NEW QUESTION # 25
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
  • A. 15 days
  • B. 7 days
  • C. 1 day
  • D. 10 days
Answer: B
Explanation:
Serious adverse events are subject to expedited reporting requirements.
* ICH E2A 3.2.2:"Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge."
* ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).
Correct answer:B (7 days).
References:
ICH E2A, §3.2.2.

NEW QUESTION # 26
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:
  • A. Print a complete paper copy
  • B. Customize access rights
  • C. Maintain accurate records throughout retention
  • D. Generate audit trails
Answer: A
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
Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?
  • A. An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
  • B. The act of reviewing and approving the investigational protocol and informed consent document
  • C. The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects
  • D. The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements
Answer: D
Explanation:
Quality assurance (QA)is proactive and systematic, designed to prevent errors and ensure compliance.
* ICH E6(R2) 1.46efines QA as "all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements." Option A describes IRB responsibilities, Option C describesaudit, and Option D describes protocol approval processes. OnlyBaccurately matches the ICH definition of QA. QA is distinct fromquality control (QC), which is operational and focused on detection of issues during conduct.
Thus, the correct answer isB.
References:
ICH E6(R2), §1.46 (Definition of Quality Assurance).

NEW QUESTION # 28
An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC. In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?
  • A. The sponsor and the IRB/IEC
  • B. The investigator/institution and the sponsor
  • C. The sponsor and the FDA
  • D. The investigator/institution and the delegated site staff
Answer: B
Explanation:
Theprotocol signature pagedocuments agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.
* ICH E6(R2) 8.2.2 (Signed protocol and amendments):Requires "the sponsor and investigator
/institution to sign the protocol and amendments, confirming agreement."
* ICH E6(R2) 4.5.1:"The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC." The sponsor-investigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols.
These bodies approve or oversee, but do not formally enter into execution of the protocol.
Thus, the correct answer isA (The investigator/institution and the sponsor).
References:
ICH E6(R2), §8.2.2 (Signed protocol and amendments).
ICH E6(R2), §4.5.1 (Investigator compliance with protocol).

NEW QUESTION # 29
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?
  • A. Within 15 working days
  • B. Within 10 working days
  • C. Immediately
  • D. Within 7 working days
Answer: C
Explanation:
ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:
* ICH E6(R2) 4.11.1: "The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol... identifies as not needing immediate reporting." Therefore, "Immediately" (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.
References:
ICH E6(R2) Good Clinical Practice, §4.11.1 (Safety reporting by investigators).===========

NEW QUESTION # 30
......
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