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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q29-Q34):
NEW QUESTION # 29
In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?
- A. At least 15 years
- B. Until the regulatory authority has approved the investigational product for use
- C. Indefinitely
- D. At least 3 years
Answer: D
Explanation:
IRBs/IECs must retain records to permit evaluation of compliance.
* ICH E6(R2) 3.4.2:"IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least3 years after completion of the trial." Extended retention (B-D) may occur institutionally, but ICH minimum is3 years.
Correct answer:A (At least 3 years).
References:
ICH E6(R2), §3.4.2.
NEW QUESTION # 30
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
- A. Completed other relevant research projects
- B. Read and understood the investigator's brochure
- C. Obtained malpractice insurance
- D. Confirmed that the site's SOPs are in place
Answer: B
Explanation:
Form FDA 1572 is the "Statement of Investigator" for IND studies.
* 21 CFR 312.53(c)(1)(vi)(b):Requires investigators to "read and understand the Investigator's Brochure."
* By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.
Other options (B-D) are not part of 1572 requirements.
Correct answer:A.
References:
21 CFR 312.53(c)(1)(vi)(b).
NEW QUESTION # 31
An approved investigational device exemption (IDE) permits a device to be:
- A. Used on a patient who is not enrolled on a clinical study
- B. Marketed as a humanitarian device
- C. Sold and marketed for profit
- D. Shipped lawfully for the purpose of conducting a clinical study
Answer: D
Explanation:
AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical investigation.
* 21 CFR 812.1(a):"An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply." It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).
Thus, the correct answer isA (Shipped lawfully for clinical study).
References:
21 CFR 812.1(a) (IDE exemption provisions).
NEW QUESTION # 32
Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?
- A. The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects
- B. The act of reviewing and approving the investigational protocol and informed consent document
- C. An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
- D. The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements
Answer: D
Explanation:
Quality assurance (QA)is proactive and systematic, designed to prevent errors and ensure compliance.
* ICH E6(R2) 1.46:Defines QA as "all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements." Option A describes IRB responsibilities, Option C describesaudit, and Option D describes protocol approval processes. OnlyBaccurately matches the ICH definition of QA. QA is distinct fromquality control (QC), which is operational and focused on detection of issues during conduct.
Thus, the correct answer isB.
References:
ICH E6(R2), §1.46 (Definition of Quality Assurance).
NEW QUESTION # 33
What is included in the Statement of Investigator (Form FDA 1572)?
- A. A statement agreeing to comply with FDA regulations
- B. A statement describing preclinical and human safety data
- C. A statement disclosing investigator financial interests
- D. A statement responding to FDA inspection observations
Answer: A
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 # 34
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