A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?
Answer(s): C
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).
Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?
Answer(s): B
IRB/IEC review focuses on ethical protection of human subjects. Equitable subject selection is a cornerstone principle.45 CFR 46.111(a)(3): "In order to approve research... the IRB shall determine that: Selection of subjects is equitable."ICH E6(R2) 3.1.2: "The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects... with particular attention to trials that may include vulnerable subjects."Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB's role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.Thus, the correct answer is B (The selection of subjects is equitable).
45 CFR 46.111(a)(3) (Equitable subject selection).ICH E6(R2), §3.1.2 (IRB/IEC role).
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
Answer(s): D
The FDA has authority to impose clinical holds and terminations on IND studies when subject safety is at risk.21 CFR 312.44(b)(1): "The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury."21 CFR 312.42(e): "If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND."Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).Thus, the correct answer is D (The FDA issued a clinical hold, and 30 days have elapsed).
21 CFR 312.44(b)(1) (Termination of an IND).21 CFR 312.42(e) (Clinical hold procedures).
Which of the following adverse events occurring during a study of an investigational new drug would require the sponsor to notify the FDA as soon as possible but in no case later than seven calendar days after the initial receipt of the information?
Sponsors must report serious, unexpected, and suspected adverse reactions (SUSARs) to the FDA.21 CFR 312.32(c)(2): "Any adverse experience associated with the use of the drug that is both serious and unexpected shall be reported... as soon as possible but no later than 7 calendar days after the sponsor's initial receipt of the information, if it is fatal or life-threatening."ICH E2A 4.2: Requires expedited reporting of life-threatening or fatal SUSARs within 7 days.Among the options, only (C) -- death from arrhythmias not previously identified in the Investigator's Brochure and suspected to be drug-related -- meets the definition of a SUSAR requiring 7-day expedited reporting. Events already listed in the IB (A, D) or unrelated to the drug (B) do not trigger expedited reporting.Thus, the correct answer is C.
21 CFR 312.32(c)(2) (Expedited safety reporting).ICH E2A, §4.2 (Expedited reporting of fatal/life-threatening adverse events).
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
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?
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?
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).
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