Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?
Answer(s): B
For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.21 CFR 56.111(a)(3): The IRB must ensure that subject selection is equitable.21 CFR 50.25(a)(3): Requires disclosure of "any compensation and/or medical treatments available if injury occurs."ICH E6(R2) 4.8.10(n): Informed consent should describe "any compensation and/or reimbursement to subjects."Thus, compensation amounts must be reviewed by IRB/IEC to ensure they are not coercive or excessive. Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.Correct answer: B (The amount of payments and compensation to subjects).
21 CFR 50.25(a)(3).ICH E6(R2), §4.8.10(n).
For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?
Consent forms must present information in language understandable to the subject, avoiding technical jargon.21 CFR 50.20: "The information... shall be understandable to the subject... and not include any exculpatory language."ICH E6(R2) 4.8.6: Information should be presented in language non-technical and understandable to the subject.Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons. The correct format uses layman's terms: "muscle aches, joint pain, and tiredness" (B).Correct answer: B.
21 CFR 50.20.ICH E6(R2), §4.8.6.
In accordance with the ICH GCP Guideline, who is responsible for ensuring that all study site personnel working on a clinical trial are qualified to conduct the trial?
The investigator has ultimate responsibility for site staff qualifications.ICH E6(R2) 4.2.4: "The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions."ICH E6(R2) 4.1.5: Investigator must maintain current documentation of staff qualifications.While sponsors and monitors oversee compliance, accountability rests with the clinical investigator. Coordinators may implement duties, but do not hold legal responsibility.Correct answer: B (The clinical investigator).
ICH E6(R2), §4.2.4.ICH E6(R2), §4.1.5.
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?
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., 6months) may occur for higher-risk studies, but longer intervals (2436 months) are not permitted.Correct answer: B (12 months).
21 CFR 56.109(f).ICH E6(R2), §3.1.4.
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?
Answer(s): A
Source data are original records where data are first recorded.ICH E6(R2) 1.51: Defines source data as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial."Since subjects directly enter responses into the EDC, the EDC record itself is the original source document. EMRs (B, C) and printouts (D) are secondary records.Correct answer: A (The EDC record).
ICH E6(R2), §1.51 (Definition of source data).
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