SOCRA CCRP Exam Dumps

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.

Minimal risk studies may qualify for exemption or expedited review under 45 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 is no 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 is D (No such requirement).

45 CFR 46.109(f) (Exempt and expedited reviews).

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.

21 CFR 54.4(b): Requires disclosure during the study and for 1 year after completion.

After three years, no disclosure is required.

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).