In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
Answer(s): B
An Independent Data Monitoring Committee (IDMC or DSMB) is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.ICH E6(R2) 5.5.1: "The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial."Thus, DSMBs/IDMCs do not perform trial approvals (A), do not design trials (C), and do not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.Therefore, the correct answer is B (Recommendations to stop a trial).
ICH E6(R2), §5.5.1 (Independent Data Monitoring Committees).
For a study with a significant risk investigational medical device that could optimize the effects of radiation therapy on cancer tumors, the investigational plan states mild burns are an anticipated effect. One subject developed severe burns with blistering. In accordance with the CFR, this effect must be reported to the sponsor and the IRB/IEC as soon as possible and at most how long after the investigator first learns of the effect?
Answer(s): D
In device trials, unanticipated adverse device effects (UADEs) must be promptly reported.21 CFR 812.150(a)(1): "An investigator shall submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect."In this case, severe burns with blistering go beyond the anticipated effect of mild burns listed in the investigational plan. Therefore, it qualifies as a UADE and triggers expedited reporting. Options A, B, and C are too short; the regulation specifically mandates a 10 working day maximum timeframe.Thus, the correct answer is D (10 working days).
21 CFR 812.150(a)(1) (Reporting requirements for investigators).
A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?
Answer(s): C
When a physician investigates a medical device for a new use (off-label indication), FDA regulations classify this as a Significant Risk Device Study, requiring an Investigational Device Exemption (IDE) in addition to IRB approval.21 CFR 812.20(a): "A sponsor shall submit an application to FDA for an investigational device exemption (IDE) if the device is to be used in a clinical investigation to determine safety and effectiveness."21 CFR 812.2(b): Significant Risk device studies require both FDA and IRB approval before initiation.An IND (B) applies to drugs and biologics, not devices. Manufacturer permission (A, D) is not a regulatory requirement, although collaboration may be necessary. OHRP approval is not applicable.Thus, the correct answer is C (IRB/IEC approval and an FDA IDE).
21 CFR 812.20(a) (IDE submission requirements).21 CFR 812.2(b) (Significant risk device studies).
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?
Answer(s): A
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).
A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. How many unused test strips should the subject have after the 10 days?
This is a drug/device accountability calculation question, testing compliance with investigational product tracking.The subject was instructed to perform 4 glucose checks per day.Over 10 days, that equals 40 tests (4 × 10 = 40).Each test requires 1 strip, so 40 strips used.Subject was given 45 strips, leaving 5 unused after 10 days.Investigators are responsible for maintaining accurate device/product accountability.ICH E6(R2) 4.6.3: "The investigator/institution should maintain records of the product's delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."This ensures monitoring can confirm that product/device use aligns with the protocol and subject adherence.Thus, the correct answer is B (5 unused test strips).
ICH E6(R2), §4.6.3 (Investigational product accountability).
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