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In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?
A. One year
B. Two years
C. Five years
D. Three years
Answer: B
Explanation:
Investigators must disclosefinancial interests and arrangementsthat could affect study integrity.
* 21 CFR 54.6(e):"Clinical investigators shall update financial disclosure information during the study and for1 year following completion of the study."
* However,21 CFR 54.4(b):requires sponsors to collect financial disclosure information "before a study begins and for1 year following completion." Because the regulation requires disclosure updates for1 year post-study, the correct answer isB (Two years) is incorrect, but some interpretations mistakenly extend beyond 1 year.
#The most accurate regulation states1 year, but CCRP exams often test the CFR's precise wording.
Thus, the correct answer isB (Two years)appears in some SoCRA prep materials but legally isOne year- I will confirm:
* #Final verified:One year(Answer A).
References:
21 CFR 54.4(b) (Financial disclosure requirements).
21 CFR 54.6(e) (Update requirements).
NEW QUESTION # 30
In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?
A. A change in the manufacturing site for the investigational product
B. The addition of a sub-investigator with the scientific training and expertise to conduct the investigation
C. A significant change in an investigator's financial interest in the investigational product
D. The addition of a new test that is intended to improve monitoring the subject for an adverse effect
Answer: A
Explanation:
The U.S. Code of Federal Regulations (CFR) specifies when sponsors must notify FDA of changes to investigational drug studies under 21 CFR 312.30. A protocol amendment is required if there is:
A change to the protocol (e.g., objectives, design, subject population, dosing, or procedures).
The addition of a new investigator.
A change in the chemistry, manufacturing, or controls (CMC) that could significantly affect product quality or safety.
Among the listed options, a change in the manufacturing site (D) directly falls under significant manufacturing changes, requiring FDA submission. Changes in investigator financial interests (B) are covered under 21 CFR 54 and reported separately, not as protocol amendments. Addition of a sub-investigator (C) does not require a formal amendment, only site-level documentation and delegation log update. Addition of a monitoring test (A) may affect the protocol, but not necessarily mandate an amendment unless it changes objectives or subject safety endpoints.
Therefore, the correct answer is D. This ensures FDA oversight of product safety, efficacy, and compliance with CMC standards before investigational use.
References:
21 CFR 312.30 (Protocol amendments).
21 CFR 312.23(a)(7) (Chemistry, manufacturing, and controls information).
NEW QUESTION # 31
A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard.
Before applying this change to all subjects, what must occur?
A. Inform all subjects
B. Train sub-investigators
C. Document change in study file
D. Obtain IRB/IEC approval
Answer: D
Explanation:
* 21 CFR 812.35(a)(2):Allows deviation without prior approval only to eliminate immediate hazards.
* Before applying broadly,IRB approvalmust be obtained.
References:21 CFR 812.35(a)(2).
NEW QUESTION # 32
An IND application must contain all EXCEPT:
A. Investigator's brochure
B. A cover sheet
C. Financial disclosure information
D. Chemistry, manufacturing, and control information
Answer: C
Explanation:
* 21 CFR 312.23(a):Requires cover sheet, CMC information, and IB.
* Financial disclosureis required separately under21 CFR 54, not part of IND content.
References:21 CFR 312.23(a); 21 CFR 54.
NEW QUESTION # 33
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?
A. Number of staff members
B. Storage cost
C. Storage facility temperature range
D. Available storage square footage
Answer: C
Explanation:
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 - particularlytemperature 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 isC (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.
References:
ICH E6(R2), ¡ì5.13.3 (Product storage requirements).
ICH E6(R2), ¡ì4.6.4 (Investigator product storage responsibilities).
NEW QUESTION # 34
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