SQA Practice Test Video Answers

1. C
The Study Director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results. According to 21 CFR 58.33, the Study Director represents the single point of study control for nonclinical laboratory studies.

2. B
According to 21 CFR 58.35, the Quality Assurance Unit must be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. This independence is essential to ensure objective oversight and unbiased evaluation of GLP compliance.

3. B
Under 21 CFR 58.35(b)(7), the QA Unit must prepare and sign a statement to be included with the final study report specifying the dates inspections were made and findings reported to management and to the Study Director.

4. B
According to OECD GLP Principles, Test Facility Management (TFM) is defined as the person(s) who has the authority and formal responsibility for the organization and operation of the test facility according to the principles of GLP.

5. B
ICH E6(R3) defines GCP as an international, ethical, scientific, and quality standard for the conduct of trials that provides assurance that the data and reported results are reliable, and that the rights, safety, and well-being of trial participants are protected.

6. C
According to SQA RQAP-GCP examination eligibility requirements, candidates without a baccalaureate degree must have the equivalent of four (4) years of full-time clinical quality assurance experience. Those with a degree need only two years.

7. B
According to 21 CFR 58.81(a), all deviations in a study from standard operating procedures shall be authorized by the Study Director and shall be documented in the raw data.

8. B
Under 21 CFR 58.35(b)(1), the QA Unit must maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article.

9. B
According to GCP guidelines and 21 CFR Part 56, the IRB/IEC is responsible for protecting the rights, safety, and well-being of human subjects involved in a trial, primarily by reviewing and approving the trial protocol and informed consent documents.

10. B
OECD GLP Principles define the Quality Assurance Programme as “a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice.”

11. B
According to ICH GCP guidelines, an audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated activities were conducted, and data were recorded, analyzed, and accurately reported according to the protocol, SOPs, GCP, and applicable regulatory requirements.

12. B
Under 21 CFR 58.61-63, equipment must be of appropriate design and adequate capacity, adequately inspected, cleaned, and maintained, and records of such activities must be maintained and retained.

13. B
The OECD Council Decision on Mutual Acceptance of Data (MAD) states that data generated in the testing of chemicals in an OECD member country in accordance with OECD Test Guidelines and OECD Principles of GLP shall be accepted in other member countries for assessment purposes.

14. B
According to 21 CFR 58.120, the protocol must be approved by the Study Director with a dated signature indicating approval. The protocol and any changes must be approved before implementation.

15. B
In GCP terminology, source documents are defined as the original documents, data, and records (e.g., hospital records, clinical charts, laboratory notes) where study data are first recorded.

16. B
According to OECD GLP Principles, raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study.

17. B
Under 21 CFR 58.185, the final report must include the dated signature of the Study Director, indicating acceptance of responsibility for the validity of the data and stating that the study was conducted in accordance with GLP regulations.

18. B
ICH E6(R3) emphasizes the Quality by Design principle, which requires identifying factors (data and processes) that are critical to ensuring trial quality and the risks that threaten the integrity of those factors.

19. B
According to 21 CFR 58.105, test and control articles shall be characterized for identity, strength, purity, and composition, and stability shall be determined before study initiation or concomitantly according to written protocols.

20. B
Under ICH GCP guidelines, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and applicable regulatory requirements.

21. B
According to 21 CFR 58.195, documentation records shall be retained for whichever of the following is shortest: two years following the date on which an application for a research permit is approved, or if not approved, two years following the date of completion of the study.

22. B
A Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) is an independent committee that reviews at intervals the progress of a clinical trial, the safety data, and critical efficacy endpoints, and recommends to the sponsor whether to continue, modify, or stop a trial.

23. B
Under 21 CFR 58.195, wet specimens, samples of test articles, and specially prepared material shall be retained only as long as the quality of the preparation affords evaluation, and should be identified by test system, study, nature, and date of collection.

24. C
While the Study Director cannot delegate overall responsibility for the study or final report signing, they can delegate specific study-related tasks to appropriately qualified personnel as defined in OECD Consensus Document No. 8.

25. B
According to ICH GCP and 21 CFR Part 56, the IRB/IEC should include at least one member whose primary area of expertise is non-scientific and at least one member who is not affiliated with the institution or is not part of the immediate family of a person affiliated with the institution.

26. B
Under 21 CFR 58.190, when a testing facility conducting nonclinical studies goes out of business, all raw data, documentation, protocols, specimens, and final reports shall be transferred to the archives of the sponsor.

27. B
According to ICH GCP guidelines, the Investigator’s Brochure is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.

28. B
OECD Advisory Document No. 17 on Application of GLP Principles to Computerised Systems requires that computerized systems used in GLP studies be validated to ensure they are fit for their intended purpose.

29. B
According to 21 CFR 58.35, the Quality Assurance Unit must periodically inspect the test facility and monitor each ongoing nonclinical laboratory study to assure management that facilities, equipment, personnel, methods, practices, records, and controls conform to GLP regulations.

30. B
Under ICH GCP and 21 CFR Part 50, informed consent must be obtained from every subject before any study procedures are performed, and the consent must be documented through a signed consent form unless the IRB has specifically waived documentation.

31. B
According to 21 CFR 58.10, FDA may refuse to consider a nonclinical laboratory study in support of a research or marketing permit if the study was not conducted in accordance with the GLP regulations.

32. B
OECD GLP Principles state that Test Facility Management must ensure that sufficient qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study.

33. B
ICH GCP defines monitoring as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements.

34. B
According to 21 CFR 58.43-51, laboratory operation areas must have adequate separation of activities to prevent any mixture or cross-contamination of test article, control article, and specimens.

35. B
ICH E6(R3) defines essential records as documents in any format associated with a clinical trial that facilitate the ongoing management of the trial and collectively allow the evaluation of the methods used and the reliability of results produced.

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