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[General] Free PDF Quiz SOCRA - CCRP - High Pass-Rate Certified Clinical Research Professi

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【General】 Free PDF Quiz SOCRA - CCRP - High Pass-Rate Certified Clinical Research Professi

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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.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q35-Q40):NEW QUESTION # 35
For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?
  • A. You might have some mild side effects while taking the investigational drug
  • B. You might have some muscle aches, joint pain, and tiredness
  • C. You might develop symptoms of myalgia, arthralgia, and tiredness
  • D. You might experience adverse events of myalgia, arthralgia, and lethargy
Answer: B
Explanation:
Consent forms must present information inlanguage understandable to the subject, avoiding technical jargon.
* 21 CFR 50.20:"The information... shall be understandable to the subject... and not include any exculpatory language."
* ICH E6(R2) 4.8.6:Information should be presented inlanguage non-technical and understandable to the subject.
Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons.
The correct format useslayman's terms: "muscle aches, joint pain, and tiredness" (B).
Correct answer:B.
References:
21 CFR 50.20.
ICH E6(R2), §4.8.6.

NEW QUESTION # 36
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 CRO/site agreements
  • C. The sponsor's written procedures
  • D. The investigational pharmacy's requirements
Answer: C
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 # 37
Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?
  • A. Maintaining control of the investigational product
  • B. Ensuring that all participating investigators are promptly informed of significant new adverse events
  • C. Reporting serious adverse events to the applicable regulatory agency
  • D. Ensuring proper monitoring of an investigation at all investigational sites
Answer: A
Explanation:
For non-sponsor investigators, responsibilities are limited tosite-level conduct and product accountability.
* ICH E6(R2) 4.6.1:"Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution."
* 21 CFR 312.61:Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.
Other responsibilities listed belong tosponsors:
* A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).
* B: Monitoring at all sites is a sponsor responsibility.
* C: Disseminating safety updates is a sponsor's role.
Correct answer (Maintaining control of IP).
References:
ICH E6(R2), §4.6.1.
21 CFR 312.61.

NEW QUESTION # 38
The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?
  • A. To provide the subject with information regarding the significant new findings
  • B. To give the subject's contact information to the sponsor in order to allow the sponsor to contact the subject
  • C. To submit this safety update to the regulatory authority
  • D. To discontinue the subject's study drug
Answer: A
Explanation:
Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.
* ICH E6(R2) 4.8.2:"If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner."
* 21 CFR 50.25(b)(5):Consent must include a statement that "significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided." Thus, the investigator mustcommunicate new risk information to the subject.
Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.
Correct answer:C.
References:
ICH E6(R2), §4.8.2.
21 CFR 50.25(b)(5).

NEW QUESTION # 39
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
  • A. Exactly one time, at study closure
  • B. Every year
  • C. There is no such requirement
  • D. Every two years
Answer: C
Explanation:
Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).
* 45 CFR 46.109(f):"Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk."
* ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.
Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.
Thus, the correct answer isD (No such requirement).
References:
45 CFR 46.109(f) (Exempt and expedited reviews).

NEW QUESTION # 40
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