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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 (Q125-Q130):

NEW QUESTION # 125
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: B

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 # 126
According to 21 CFR Part 11, each electronic signature must be unique and:

Answer: C

Explanation:
* 21 CFR 11.100(a):Requires that electronic signatures be "unique to one individual and shall not be reused or reassigned to anyone else."
* This ensures accountability and audit trail integrity.
References:21 CFR 11.100(a).


NEW QUESTION # 127
Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?

Answer: B

Explanation:
370 × 1.20 =444 mg/m².
Accurate dosing calculations are critical for protocol adherence and patient safety.
References:Standard pharmacology dose adjustment principles; ICH E6(R2) §4.5.1.


NEW QUESTION # 128
A sponsor is permitted to charge for an investigational drug but must provide what documentation?

Answer: B

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 # 129
According to the CFR, when children who are wards of the state are enrolled into a clinical trial, what is required?

Answer: B

Explanation:
Children who are wards of the state receiveadditional protectionsin clinical research.
* 45 CFR 46.409(b):For research involving wards, "the IRB shall require appointment of an advocate for each child, in addition to any guardian or other advocate who would ordinarily be provided."
* The advocate must have background and experience to act in the child's best interest and cannot be associated with the research.
Thus, anIRB-appointed advocateis mandatory to ensure independent representation of the ward's rights.
References:45 CFR 46.409(b).


NEW QUESTION # 130
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