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[General] Avail Realistic CCRP Test Registration to Pass CCRP on the First Attempt

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【General】 Avail Realistic CCRP Test Registration to Pass CCRP on the First Attempt

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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 (Q42-Q47):NEW QUESTION # 42
Which of the following is one of the responsibilities of an investigator?
  • A. Maintaining accurate and current case histories of study subjects
  • B. Selecting qualified monitors on the basis of training, experience, and expertise
  • C. Participating in the IRB/IEC voting process for approval of their protocol
  • D. Updating the investigator brochure with new safety information
Answer: A
Explanation:
Investigators are required to maintain accurate subject records, often referred to ascase histories.
* 21 CFR 312.62(b):"An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation."
* ICH E6(R2) 4.9.0:Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.
Incorrect options:
* B: Investigators may present protocols but cannot vote on IRB approval.
* C: Sponsor responsibility (ICH E6 §5.18).
* D: Sponsors are responsible for IB updates (ICH E6 §7.3.1).
Correct answer:A.
References:
21 CFR 312.62(b).
ICH E6(R2), §4.9.0.

NEW QUESTION # 43
Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?
  • A. The sponsor is qualified to provide oversight of the trial
  • B. A plan for the publication of study results is in place
  • C. The investigator has adequate access to patients eligible for the trial
  • D. The selection of subjects is equitable
Answer: D
Explanation:
IRB/IEC review focuses onethical protection of human subjects. Equitable subject selection is a cornerstone principle.
* 45 CFR 46.111(a)(3):"In order to approve research... the IRB shall determine that:Selection of subjects is equitable."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects... with particular attention to trials that may include vulnerable subjects." Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB's role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.
Thus, the correct answer isB (The selection of subjects is equitable).
References:
45 CFR 46.111(a)(3) (Equitable subject selection).
ICH E6(R2), §3.1.2 (IRB/IEC role).

NEW QUESTION # 44
Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?
  • A. The Belmont Report
  • B. The Nuremberg Code
  • C. The Declaration of Helsinki
  • D. The ICH Guidelines
Answer: A
Explanation:
TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principles guiding human subject research:
* Respect for Persons(informed consent, autonomy, protection of vulnerable populations).
* Beneficence(maximize benefits, minimize harms).
* Justice(fairness in subject selection and treatment).
* TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.
* TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.
* TheICH Guidelines (1996)outline harmonized regulatory requirements for good clinical practice.
Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.
Thus, the correct answer isD (The Belmont Report).
References:
The Belmont Report (1979), National Commission for the Protection of Human Subjects.
45 CFR 46 (Human Subject Protections).

NEW QUESTION # 45
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
  • A. The reviewing IRB/IEC
  • B. The clinical investigator
  • C. The medical monitor
  • D. A data safety monitoring board
Answer: A
Explanation:
Minimal risk determination is a regulatory function of the IRB/IEC.
* 45 CFR 46.102(j)efines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.
* 45 CFR 46.109(a):The IRB has authority to approve, require modifications, or disapprove research, including assessment ofrisk level.
* Investigators may propose a study as minimal risk, but only theIRB/IEC can formally classify it.
This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.
References:45 CFR 46.102(j), 46.109(a).

NEW QUESTION # 46
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
  • A. The sponsor failed to submit an accurate annual report of the study to the FDA
  • B. The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study
  • C. An investigator failed to submit safety reports to the FDA
  • D. The FDA issued a clinical hold, and 30 days have elapsed
Answer: D
Explanation:
The FDA has authority to imposeclinical holds and terminationson IND studies when subject safety is at risk.
* 21 CFR 312.44(b)(1):"The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury."
* 21 CFR 312.42(e):"If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND." Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination.
IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).
Thus, the correct answer isD (The FDA issued a clinical hold, and 30 days have elapsed).
References:
21 CFR 312.44(b)(1) (Termination of an IND).
21 CFR 312.42(e) (Clinical hold procedures).

NEW QUESTION # 47
......
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