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NEW QUESTION # 77
Which of the following is an example of an additional protection required when conducting research on children?
Answer: C
Explanation:
Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and howassent is obtained, in addition to parental permission. Exact extracts:
* 45 CFR 46.408(a): "The IRB shall determine...whether and to what extent children are capable of providing assent."
* ICH E6(R2) 4.8.12: "Where a subject is unable to give consent personally,assent should be obtained when appropriate, in accordance with applicable regulatory requirement(s)."Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not universal requirements for all pediatric research.
References:
ICH E6(R2) Good Clinical Practice, §4.8.12 (Informed consent/assent).
45 CFR 46 Subpart D-Additional Protections for Children, §46.408(a).===========
NEW QUESTION # 78
According to ICH GCP, sponsor-specific essential documents must be retained until:
Answer: C
Explanation:
* ICH E6(R2) 5.5.12 & 8.1:Essential documents must be retained2 years after the last approval of a marketing application in an ICH region and until no applications are pending, or2 years after discontinuation of development.
This ensures availability for inspection.
References:ICH E6(R2) §§5.5.12, 8.1.
NEW QUESTION # 79
According to the ICH GCP Guidelines, what is the purpose of source documents?
Answer: A
Explanation:
* ICH E6(R2) 1.52:Source documents are "original documents, data, and records... necessary for the reconstruction and evaluation of the trial."
* Their main role is to document treatment and verify CRFs.
References:ICH E6(R2), §1.52.
NEW QUESTION # 80
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?
Answer: D
Explanation:
Consent forms must present information inlanguage 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 inlanguage 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 useslayman's terms: "muscle aches, joint pain, and tiredness" (B).
Correct answer:B.
References:
21 CFR 50.20.
ICH E6(R2), §4.8.6.
NEW QUESTION # 81
A clinical investigator is developing the assent procedure for the enrollment of children into a new pediatric clinical trial. The ages of the children are described in the IRB/IEC submission. A description of which of the following must also be included in the submission?
Answer: C
Explanation:
Children are avulnerable populationrequiring additional protections.
* 45 CFR 46.408(a):Requires "adequate provisions for soliciting the assent of the children, when in the judgment of the IRB, the children are capable of providing assent."
* 45 CFR 46.402:Defines "assent" as a child's affirmative agreement to participate.
* IRBs must consider theage, maturity, and psychological stateof the children when determining assent capability.
Economic status (B) is irrelevant to assent. Physiological status (C) pertains to eligibility, not assent. Provider notification (D) may be local practice but not required by regulation.
Correct answer:A (Psychological status).
References:
45 CFR 46.402-408.
NEW QUESTION # 82
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