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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 (Q104-Q109):

NEW QUESTION # 104
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

Answer: A

Explanation:
IRBs must review protocols at least annually to ensure ongoing subject protection.
* 21 CFR 56.109(f):"An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year."
* ICH E6(R2) 3.1.4:"The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk, but at least once per year." This establishes12 monthsas the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24-36 months) are not permitted.
Correct answer:B (12 months).
References:
21 CFR 56.109(f).
ICH E6(R2), §3.1.4.


NEW QUESTION # 105
After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

Answer: B

Explanation:
Audits are part of sponsor quality assurance to ensure trial compliance.
* ICH E6(R2) 5.19.3:"The sponsor's auditing procedures should include the provision of anaudit certificatewhere required."
* ICH E6(R2) 8.2.20:Audit certificates are essential documents generated and retained by the sponsor.
IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsorissues and maintains audit certificates, providing them to sites when appropriate.
Correct answer:D.
References:
ICH E6(R2), §5.19.3.
ICH E6(R2), §8.2.20.


NEW QUESTION # 106
In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study. Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?

Answer: D

Explanation:
* ICH E6(R2) 4.4.1:"Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC."
* Sponsors must confirm IRB approval before authorizing initiation.
References:ICH E6(R2), §4.4.1.


NEW QUESTION # 107
Upon completion of a study, the investigator should do which of the following?

Answer: A

Explanation:
Investigators must formally close out a trial with the IRB/IEC.
* ICH E6(R2) 4.13.2:"Upon completion of the trial, the investigator/institution should provide the IRB
/IEC with a summary of the trial's outcome."
* 21 CFR 312.66:Reinforces investigator's duty to keep IRB informed throughout study lifecycle.
This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).
Thus, the correct answer isA (Provide final report to IRB/IEC).
References:
ICH E6(R2), §4.13.2 (Final reporting requirement).


NEW QUESTION # 108
A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?

Answer: A

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 # 109
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