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[Hardware] Exam CCRP Bootcamp - Trustworthy CCRP Exam Content

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【Hardware】 Exam CCRP Bootcamp - Trustworthy CCRP Exam Content

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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 (Q105-Q110):NEW QUESTION # 105
In accordance with the CFR and the ICH GCP Guideline, which of the following is directly responsible for submitting protocols and amendments to the IRB/IEC for review?
  • A. The contract research organization
  • B. The Food and Drug Administration
  • C. The investigator
  • D. The sponsor
Answer: C
Explanation:
Theinvestigatorbears direct responsibility for ensuring IRB/IEC review and approval before initiating a study or implementing any amendments.
* ICH E6(R2) 4.4.1:"Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, and any other written information to be provided to subjects."
* 21 CFR 312.66:"An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study." While sponsors may provide protocol documents, the legal obligation to submit and maintain IRB/IEC approval rests with the investigator at each site. CROs act under sponsor delegation but cannot replace investigator accountability.
Thus, the correct answer isB (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibilities).
21 CFR 312.66 (Investigator assurance of IRB oversight).

NEW QUESTION # 106
An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
  • A. Sponsor
  • B. Research pharmacist
  • C. OHRP
  • D. FDA
Answer: A
Explanation:
* 21 CFR 812.150(a)(1):Investigators must report unanticipated adverse device effects to thesponsor within 10 working days.
* Sponsor is then responsible for notifying FDA and all investigators.
References:21 CFR 812.150(a)(1).

NEW QUESTION # 107
A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?
  • A. Program manager
  • B. Clinical investigator
  • C. IRB/IEC
  • D. Sponsor
Answer: B
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 # 108
What is included in the Statement of Investigator (Form FDA 1572)?
  • A. A statement describing preclinical and human safety data
  • B. A statement agreeing to comply with FDA regulations
  • C. A statement disclosing investigator financial interests
  • D. A statement responding to FDA inspection observations
Answer: B
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 # 109
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
  • A. Obtained malpractice insurance
  • B. Confirmed that the site's SOPs are in place
  • C. Completed other relevant research projects
  • D. Read and understood the investigator's brochure
Answer: D
Explanation:
Form FDA 1572 is the "Statement of Investigator" for IND studies.
* 21 CFR 312.53(c)(1)(vi)(b):Requires investigators to "read and understand the Investigator's Brochure."
* By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.
Other options (B-D) are not part of 1572 requirements.
Correct answer:A.
References:
21 CFR 312.53(c)(1)(vi)(b).

NEW QUESTION # 110
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