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High Pass-Rate CCRP Fresh Dumps, Updated CCRP Testkings

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High Pass-Rate CCRP Fresh Dumps, Updated CCRP Testkings

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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 (Q34-Q39):NEW QUESTION # 34
Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?
  • A. The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects
  • B. 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
  • C. The act of reviewing and approving the investigational protocol and informed consent document
  • D. An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
Answer: B
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 # 35
Upon completion of a study, the investigator should do which of the following?
  • A. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome
  • B. Ensure that all payments from sponsor have been received
  • C. Provide the IRB/IEC a final report, but only if the study has a positive outcome
  • D. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
Answer: A
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 # 36
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 3 years
  • B. At least 15 years
  • C. Indefinitely
  • D. Until the regulatory authority has approved the investigational product for use
Answer: A
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 # 37
Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?
  • A. The amount of payments and compensation to subjects
  • B. The itemized study budget
  • C. The investigator's clinical trial agreement with the sponsor
  • D. The drug development and marketing plan
Answer: A
Explanation:
For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.
* 21 CFR 56.111(a)(3):The IRB must ensure that subject selection is equitable.
* 21 CFR 50.25(a)(3):Requires disclosure of "any compensation and/or medical treatments available if injury occurs."
* ICH E6(R2) 4.8.10(n):Informed consent should describe "any compensation and/or reimbursement to subjects." Thus,compensation amountsmust be reviewed by IRB/IEC to ensure they are not coercive or excessive.
Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.
Correct answer:B (The amount of payments and compensation to subjects).
References:
21 CFR 50.25(a)(3).
ICH E6(R2), §4.8.10(n).

NEW QUESTION # 38
In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?
  • A. Regulatory authority
  • B. Institution
  • C. Investigator
  • D. Sponsor
Answer: D
Explanation:
* ICH E6(R2) 5.5.3:Sponsors are responsible for validating computerized systems used in trials.
Investigators ensure proper data entry, but system compliance lies with sponsor.
References:ICH E6(R2), §5.5.3.

NEW QUESTION # 39
......
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