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[General] CCRP Learning Mode - CCRP New Guide Files

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【General】 CCRP Learning Mode - CCRP New Guide Files

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Our SOCRA CCRP exam dumps give help to give you an idea about the actual Certified Clinical Research Professional (CCRP) (CCRP) exam. You can attempt multiple Certified Clinical Research Professional (CCRP) (CCRP) exam questions on the software to improve your performance. Itcerttest has many Certified Clinical Research Professional (CCRP) (CCRP) practice questions that reflect the pattern of the real Certified Clinical Research Professional (CCRP) (CCRP) exam. Itcerttest allows you to create a Certified Clinical Research Professional (CCRP) (CCRP) exam dumps according to your preparation. It is easy to create the SOCRA CCRP practice questions by following just a few simple steps. Our CCRP exam dumps are customizable based on the time and type of questions.
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 (Q127-Q132):NEW QUESTION # 127
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 CRO
  • B. The IRB/IEC
  • C. The investigator
  • D. The sponsor
Answer: D
Explanation:
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).===========

NEW QUESTION # 128
According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB after completion of the trial at the site?
  • A. The data safety monitoring summary
  • B. The final subject enrollment log
  • C. The final report
  • D. The monitoring close-out visit report
Answer: C
Explanation:
When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is outlined in both ICH and CFR:
ICH E6(R2) 4.13: "Upon completion of the trial, the investigator should provide the IRB/IEC with a summary of the trial's outcome."
21 CFR 312.66: Requires investigators to "report to the IRB all changes in the research activity and all unanticipated problems involving risk, and to provide reports at the end of the study." The final report provides closure and documentation that the study was conducted ethically and in compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB submission.
Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study completion, outcome, and compliance with ethical oversight.
References:
ICH E6(R2), §4.13 (Final reporting to IRB/IEC).
21 CFR 312.66 (IRB review and reporting).

NEW QUESTION # 129
A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?
  • A. A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial
  • B. A statement confirming that the subject has received a copy of the signed consent document
  • C. An explanation of the person to contact at the sponsor for further information regarding research subjects' rights
  • D. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Answer: D
Explanation:
Theinformed consent processmust include all basic elements listed in federal regulations.
* 21 CFR 50.25(a)(4):Requires "a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject."
* ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.
This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.
Incorrect options:
* A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.
* B: Financial disclosures may be required for IRB review, not subject-facing.
* C: Subjects do receive a copy, but it is not a required consentelementin regulations.
Correct answer.
References:
21 CFR 50.25(a)(4).
ICH E6(R2), §4.8.10(c).

NEW QUESTION # 130
In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:
  • A. 5 years
  • B. 2 years
  • C. 15 years
  • D. 3 years
Answer: B
Explanation:
TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57 (c)and21 CFR 312.62(c).
* 21 CFR 312.57(c):"A sponsor shall retain the records and reports... for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified."
* 21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.
This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.
Thus, the correct answer isA (2 years).
References:
21 CFR 312.57(c) (Sponsor record retention).
21 CFR 312.62(c) (Investigator record retention).

NEW QUESTION # 131
What is included in the Statement of Investigator (Form FDA 1572)?
  • A. A statement responding to FDA inspection observations
  • B. A statement describing preclinical and human safety data
  • C. A statement agreeing to comply with FDA regulations
  • D. A statement disclosing investigator financial interests
Answer: C
Explanation:
FormFDA 1572is the investigator's signed agreement to follow regulations.
* 21 CFR 312.53(c)(1)(vi)(c):Requires investigators to sign Form 1572, committing to conduct trials in accordance withFDA regulations (21 CFR 50 & 56).
* The form includes commitments to personally supervise, obtain informed consent, maintain records, and permit FDA inspections.
It does not include financial disclosures (covered under21 CFR 54) or preclinical data (in theIB).
References:21 CFR 312.53(c)(1)(vi)(c).

NEW QUESTION # 132
......
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