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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 (Q85-Q90):

NEW QUESTION # 85
After randomization, investigational drug is shipped to site. Who is responsible for accountability?

Answer: C

Explanation:
* ICH E6(R2) 4.6.1:"Responsibility for investigational product accountability at the trial site rests with the investigator."
* May delegate to pharmacist or coordinator, butultimate responsibilitylies with investigator.
References:ICH E6(R2) §4.6.1.


NEW QUESTION # 86
A sponsor is permitted to charge for an investigational drug but must provide what documentation?

Answer: A

Explanation:
* 21 CFR 312.8(b):Sponsors may charge for investigational drugs only if they demonstrate that the drug providespotential clinical benefitand asignificant advantageover existing therapy.
* FDA must approve charging requests.
References:21 CFR 312.8(b).


NEW QUESTION # 87
Protecting prisoners' rights to voluntarily participate in research is an example of which Belmont principle?

Answer: C

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 pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?

Answer: D

Explanation:
TheInvestigator's Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.
* ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.
* ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.
The "results of recent nude mouse study" (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.
Thus, the correct answer isB (Results of recent nude mouse study).
References:
ICH E6(R2), §7.2.3-7.2.4 (Contents of Investigator's Brochure).


NEW QUESTION # 89
A research site was invited to participate in an investigational drug study. Which of the following parties is responsible for determining the risk-benefit ratio at the site?

Answer: A

Explanation:
Therisk-benefit ratiois a core responsibility of the IRB/IEC.
* 21 CFR 56.111(a)(2):"Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result."
* ICH E6(R2) 3.1.2:IRB/IEC must safeguard rights, safety, and well-being of subjects, with special attention to risk-benefit evaluation.
Investigators (A) provide medical judgment but do not formally approve the risk-benefit balance. Sponsors (D) design studies but must submit to IRB for independent review. Legal counsel (C) is not part of the scientific/ethical evaluation.
Thus,IRB/IEC is directly responsible for approving the risk-benefit ratio.
References:
21 CFR 56.111(a)(2).
ICH E6(R2), §3.1.2.


NEW QUESTION # 90
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