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A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. Where can the sub-investigator find a description of the unblinding procedure?
A. The Investigator's Brochure
B. The informed consent form
C. The study protocol
D. The case report form
Answer: C
Explanation:
Unblinding procedures are aprotocol-level responsibilitybecause they involve trial design, safety management, and subject protection.
* ICH E6(R2) 6.0 (Protocol and amendments):Requires the protocol to specify "the treatment(s) and treatment periods, procedures for randomization and blinding, andprocedures for breaking codes."
* ICH E6(R2) 4.7:"The investigator should follow the trial's randomization procedure, if any, and should ensure that the code is broken only in accordance with the protocol." The informed consent (A) explains risks and rights but does not include operational unblinding procedures.
The Investigator's Brochure (B) summarizes preclinical/clinical data but does not dictate site-specific trial management. The CRF (D) is for data capture and has no procedural detail.
Therefore, the correct answer isC (The study protocol), as it outlines unblinding steps and documentation requirements.
References:
ICH E6(R2), ¡ì6.0 (Protocol content).
ICH E6(R2), ¡ì4.7 (Randomization and unblinding).
NEW QUESTION # 29
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?
A. At any time, but only if the investigator agrees that the information is essential
B. At any time, at the discretion of the IRB/IEC
C. At any time, but only if the sponsor and investigator agree that the information is essential
D. At any time, but only if the sponsor agrees that the information is essential
Answer: B
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 ¡ì50.25.The IRB may require that information, in addition to that specifically mentioned in ¡ì50.25, 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 isA (At any time, at the discretion of the IRB/IEC).
References:
ICH E6(R2), ¡ì3.1.2 (IRB responsibilities).
21 CFR 56.109(b) (IRB review of informed consent).
NEW QUESTION # 30
In accordance with the ICH GCP Guideline, who is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms and in all required reports?
A. The IRB/IEC coordinator
B. The clinical investigator
C. The quality control specialist
D. The contract research organization monitor
Answer: B
Explanation:
The investigator holds ultimate responsibility for all data reported.
* ICH E6(R2) 4.9.1:"The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports."
* Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.
Correct answer:A (The clinical investigator).
References:
ICH E6(R2), ¡ì4.9.1.
NEW QUESTION # 31
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
A. Investigator/institution
B. OHRP
C. DSMB
D. Regulatory authority
Answer: A
Explanation:
* ICH E6(R2) 5.6.1:"The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial."This ensures transparency in compensation, reimbursement, and budget.
References:ICH E6(R2) ¡ì5.6.1.
NEW QUESTION # 32
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
A. The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study
B. The FDA issued a clinical hold, and 30 days have elapsed
C. The sponsor failed to submit an accurate annual report of the study to the FDA
D. An investigator failed to submit safety reports to the FDA
Answer: B
Explanation:
The FDA has authority to imposeclinical holds and terminationson 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 isD (The FDA issued a clinical hold, and 30 days have elapsed).
References:
21 CFR 312.44(b)(1) (Termination of an IND).
21 CFR 312.42(e) (Clinical hold procedures).
NEW QUESTION # 33
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