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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q23-Q28):

NEW QUESTION # 23
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

Answer: D

Explanation:
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 establishes12 monthsas the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24-36 months) are not permitted.
Correct answer:B (12 months).
References:
21 CFR 56.109(f).
ICH E6(R2), §3.1.4.


NEW QUESTION # 24
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: D

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 # 25
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: B

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), §5.13.3 (Product storage requirements).
ICH E6(R2), §4.6.4 (Investigator product storage responsibilities).


NEW QUESTION # 26
Which of the following elements should NOT influence the investigator's ability to obtain endpoint data?

Answer: A

Explanation:
* Endpoint data collection is based onprotocol designand subject compliance, not CRF formatting.
* ICH E6(R2) 4.9.0:Investigator responsible for data accuracy regardless of CRF complexity.
References:ICH E6(R2), §4.9.0.


NEW QUESTION # 27
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 # 28
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