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[General] Exam CCRP Assessment - Test CCRP Topics Pdf

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【General】 Exam CCRP Assessment - Test CCRP Topics Pdf

Posted at yesterday 21:18      View：9 | Replies：0        Print      Only Author   [Copy Link] 1#
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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q40-Q45):NEW QUESTION # 40
What is included in the Statement of Investigator (Form FDA 1572)?
  • A. A statement describing preclinical and human safety data
  • B. A statement agreeing to comply with FDA regulations
  • C. A statement disclosing investigator financial interests
  • D. A statement responding to FDA inspection observations
Answer: B
Explanation:
FormFDA 1572is the investigator's signed agreement to follow regulations.
* 21 CFR 312.53(c)(1)(vi)(c):Requires investigators to sign Form 1572, committing to conduct trials in accordance withFDA regulations (21 CFR 50 & 56).
* The form includes commitments to personally supervise, obtain informed consent, maintain records, and permit FDA inspections.
It does not include financial disclosures (covered under21 CFR 54) or preclinical data (in theIB).
References:21 CFR 312.53(c)(1)(vi)(c).

NEW QUESTION # 41
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?
  • A. The completed subject identification code list
  • B. The master randomization list
  • C. The audit certificate
  • D. The final trial closeout monitoring report
Answer: A
Explanation:
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.
* ICH E6(R2) 8.3.21:"Subject Identification Code List - A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period."
* ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer isB (Completed Subject Identification Code List).
References:
ICH E6(R2), §8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), §8.4 (Essential documents for trial closure).

NEW QUESTION # 42
Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?
  • A. Maintaining control of the investigational product
  • B. Reporting serious adverse events to the applicable regulatory agency
  • C. Ensuring proper monitoring of an investigation at all investigational sites
  • D. Ensuring that all participating investigators are promptly informed of significant new adverse events
Answer: A
Explanation:
For non-sponsor investigators, responsibilities are limited tosite-level conduct and product accountability.
* ICH E6(R2) 4.6.1:"Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution."
* 21 CFR 312.61:Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.
Other responsibilities listed belong tosponsors:
* A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).
* B: Monitoring at all sites is a sponsor responsibility.
* C: Disseminating safety updates is a sponsor's role.
Correct answer (Maintaining control of IP).
References:
ICH E6(R2), §4.6.1.
21 CFR 312.61.

NEW QUESTION # 43
A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?
  • A. IRB/IEC approval and an FDA IDE
  • B. The Office for Human Research Protections (OHRP) and manufacturer approvals
  • C. IRB/IEC and manufacturer approval
  • D. IRB/IEC approval and an FDA IND
Answer: A
Explanation:
When a physician investigates amedical device for a new use (off-label indication), FDA regulations classify this as aSignificant Risk Device Study, requiring anInvestigational Device Exemption (IDE)in addition to IRB approval.
* 21 CFR 812.20(a):"A sponsor shall submit an application to FDA for aninvestigational device exemption (IDE)if the device is to be used in a clinical investigation to determine safety and effectiveness."
* 21 CFR 812.2(b):Significant Risk device studies requireboth FDA and IRB approvalbefore initiation.
An IND (B) applies to drugs and biologics, not devices. Manufacturer permission (A, D) is not a regulatory requirement, although collaboration may be necessary. OHRP approval is not applicable.
Thus, the correct answer isC (IRB/IEC approval and an FDA IDE).
References:
21 CFR 812.20(a) (IDE submission requirements).
21 CFR 812.2(b) (Significant risk device studies).

NEW QUESTION # 44
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?
  • A. 6 months
  • B. 24 months
  • C. 12 months
  • D. 36 months
Answer: C
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 # 45
......
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