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Each question shows the correct answer and an explanation of why it is right
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?
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 establishes 12 months as 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).
21 CFR 56.109(f).
ICH E6(R2), 3.1.4.
A company's CEO wants to commercially promote a device under an IDE study. This plan:
21 CFR 812.7: Prohibits promotion of investigational devices or claiming safety/effectiveness until FDA approval is granted.
Investigational devices may only be used in clinical trials, not marketed.
Thus, promotion during an IDE study is an FDA violation.
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. The Subject Identification Code List is a key essential document for ensuring traceability while maintaining confidentiality.
ICH E6(R2) 8.3.21: ''Subject Identification Code List --- A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period.''
ICH E6(R2) 8.4: Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. The subject code list ensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer is B (Completed Subject Identification Code List).
ICH E6(R2), 8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), 8.4 (Essential documents for trial closure).
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?
The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
21 CFR 50.25(a): Requires the consent form to contain all basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
ICH E6(R2) 4.8.10: Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICD must include all applicable mandated basic elements (D). Options A and B confuse who signs---subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer: D.
21 CFR 50.25(a).
ICH E6(R2), 4.8.10.
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?
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 an audit certificate where 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 sponsor issues and maintains audit certificates, providing them to sites when appropriate.
Correct answer: D.
ICH E6(R2), 5.19.3.
ICH E6(R2), 8.2.20.
130 questions covering all exam domains, starting from $20
3 domains from the SOCRA CCRP exam outline, with approximate weightings. Every sample question above is tagged with the domain it comes from
Coordinate protocol development and initial study setup including document creation, stakeholder approvals, site selection, staff training, and compliance evaluation. This domain covers the foundational tasks before a clinical trial begins, from drafting study protocols to preparing informed consent forms and ensuring IRB review.
Execute study protocols, manage investigational products, identify and report safety issues, recruit and monitor subjects, maintain essential records, communicate with stakeholders, and conduct audits. This domain focuses on the active conduct of the clinical trial and the day-to-day operational responsibilities throughout the study lifecycle.
Perform closeout visit activities and develop final reports to IRB, sponsor, regulatory authorities, and clinical trials registry. This domain covers the wrap-up phase of a clinical trial including verification of documentation and accountability of investigational products.
Common questions about the exam itself
