Important SOCRA CCRP Exam Questions

Answer: D

Explanation:

21 CFR 812.150(a)(4): Any deviation from investigational plan made to protect the life or physical well-being of a subject in an emergency must be reported to the sponsor and IRB within 5 working days.

Unanticipated adverse device effects have a 10-day reporting window.

Answer: A

Explanation:

The IRB/IEC is empowered to protect subjects and ensure informed consent remains accurate, complete, and understandable.

ICH E6(R2) 3.1.2: ''The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid... when considering the adequacy and completeness of the written information to be provided to the subjects.''

21 CFR 56.109(b): ''The IRB shall require that information given to subjects as part of informed consent is in accordance with 50.25. The IRB may require that information, in addition to that specifically mentioned in 50.25, be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of subjects.''

This confirms that the IRB/IEC has unilateral authority to request additional information at any time, regardless of sponsor or investigator agreement.

Thus, the correct answer is A (At any time, at the discretion of the IRB/IEC).

ICH E6(R2), 3.1.2 (IRB responsibilities).

21 CFR 56.109(b) (IRB review of informed consent).

Answer: C

Explanation:

The sponsor holds ultimate responsibility for trial oversight and compliance.

ICH E6(R2) 5.20.1: If noncompliance is discovered, the sponsor must ''take prompt action to secure compliance'' and, if necessary, terminate participation of the investigator/institution.

21 CFR 312.56(b): Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.

While investigators commit to protocol adherence, once deviations are identified, the sponsor must act to safeguard subjects and trial validity.

Answer: B

Explanation:

Monitoring reports are sponsor-controlled documents.

ICH E6(R2) 5.18.6: ''The monitor should submit a written report to the sponsor after each trial-site visit... The sponsor should review and follow up on the monitoring report.''

ICH E6(R2) 8.1 & 8.2.22: Monitoring visit reports are essential documents maintained by the sponsor.

Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.

Thus, the correct answer is B (The sponsor).

ICH E6(R2), 5.18.6 (Monitoring reports).

ICH E6(R2), 8.2.22 (Essential documents: monitoring visit reports).

Answer: C

Explanation:

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3: ''The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s).''

ICH E6(R2) 4.6.4: ''The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol.''

During site qualification/selection, the monitor evaluates storage conditions --- particularly temperature ranges --- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer is C (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.

ICH E6(R2), 5.13.3 (Product storage requirements).

ICH E6(R2), 4.6.4 (Investigator product storage responsibilities).