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[General] CCRP Pass4sure & CCRP Test Duration

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【General】 CCRP Pass4sure & CCRP Test Duration

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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 (Q86-Q91):NEW QUESTION # 86
A clinical investigator is developing the assent procedure for the enrollment of children into a new pediatric clinical trial. The ages of the children are described in the IRB/IEC submission. A description of which of the following must also be included in the submission?
  • A. The psychological status of the children
  • B. The pediatrician (primary care provider notification process)
  • C. The physiological status of the children
  • D. The economic status of the children
Answer: A
Explanation:
Children are avulnerable populationrequiring additional protections.
* 45 CFR 46.408(a):Requires "adequate provisions for soliciting the assent of the children, when in the judgment of the IRB, the children are capable of providing assent."
* 45 CFR 46.402efines "assent" as a child's affirmative agreement to participate.
* IRBs must consider theage, maturity, and psychological stateof the children when determining assent capability.
Economic status (B) is irrelevant to assent. Physiological status (C) pertains to eligibility, not assent. Provider notification (D) may be local practice but not required by regulation.
Correct answer:A (Psychological status).
References:
45 CFR 46.402-408.

NEW QUESTION # 87
Protecting prisoners' rights to voluntarily participate in research is an example of which Belmont principle?
  • A. Dignity
  • B. Justice
  • C. Beneficence
  • D. Respect for Persons
Answer: D
Explanation:
* Belmont Report:"Respect for Persons" incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).
* Prisoners require special safeguards because of restricted liberty and potential coercion.
References:Belmont Report (1979).

NEW QUESTION # 88
A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?
  • A. Record storage plan
  • B. Case report forms
  • C. Recruitment materials
  • D. List of potential subjects
Answer: C
Explanation:
* ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.
* CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.
References:ICH E6(R2) §3.1.2; FDA Recruitment Guidance, 1998.

NEW QUESTION # 89
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?
  • A. The electronic medical record
  • B. The EDC record
  • C. A printout of the electronic medical record
  • D. A printout of the EDC record
Answer: B
Explanation:
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51efines source data as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial." Since subjects directly enter responses into the EDC, theEDC record itself is the original source document.
EMRs (B, C) and printouts (D) are secondary records.
Correct answer:A (The EDC record).
References:
ICH E6(R2), §1.51 (Definition of source data).

NEW QUESTION # 90
In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?
  • A. The Investigator's Brochure
  • B. The sponsor's written procedures
  • C. The CRO/site agreements
  • D. The investigational pharmacy's requirements
Answer: B
Explanation:
Handling of investigational product (IP), including returns, is governed bysponsor's written procedures.
* ICH E6(R2) 4.6.3:"The investigator/institution should maintain records of the product's delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."
* ICH E6(R2) 5.13.3:"The sponsor should ensure that written procedures include instructions for... the return or alternative disposition of unused product(s)." The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.
Thus, the correct answer isB (The sponsor's written procedures).
References:
ICH E6(R2), §4.6.3 (Investigator product accountability).
ICH E6(R2), §5.13.3 (Sponsor product return procedures).

NEW QUESTION # 91
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