Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?
Answer(s): B
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 describes audit, and Option D describes protocol approval processes. Only B accurately matches the ICH definition of QA. QA is distinct from quality control (QC), which is operational and focused on detection of issues during conduct.Thus, the correct answer is B.
ICH E6(R2), §1.46 (Definition of Quality Assurance).
Which of the following statements about the initial IND application submission by a sponsor to the
An Investigational New Drug (IND) application provides FDA with data to justify human testing.21 CFR 312.23(a)(3): The IND must contain "a description of the general investigational plan, including the rationale for the drug or the research study."The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.Financial disclosures (D) are reported separately under 21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under 21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.Thus, the correct answer is B (Rationale and plan for human testing).
21 CFR 312.23(a)(3) (IND contents).21 CFR 312.20 (General IND requirements).
In accordance with 45 CFR 46, in addition to the Office for Human Research Protections (OHRP), a suspension of IRB/IEC approval must be reported to which of the following?
If IRB/IEC approval is suspended or terminated, reporting is required to protect oversight and accountability.45 CFR 46.113: "An IRB shall notify the institutional officials, the department or agency head, and OHRP (when applicable) of any suspension or termination of IRB approval."This ensures transparency and institutional responsibility for compliance. Internal hospital committees or directors (A, C, D) are not mandated reporting entities.Thus, the correct answer is B (Appropriate institutional officials).
45 CFR 46.113 (Suspension or termination of IRB approval).
In accordance with the Belmont Report, obtaining voluntary informed consent from subjects prior to enrolling them in a clinical trial is an example of which of the following ethical principles?
The Belmont Report (1979) established three key ethical principles:Respect for Persons: Requires informed consent, recognition of autonomy, and protection of vulnerable individuals.Beneficence: Obligation to maximize benefits and minimize harm.Justice: Ensuring fairness in subject selection and distribution of research burdens/benefits.Voluntary informed consent embodies Respect for Persons, as subjects are given adequate information and freedom of choice. "Do no harm" (A) is a Hippocratic principle but not Belmont terminology.Thus, the correct answer is B (Respect for persons).
The Belmont Report (1979), Part B: Basic Ethical Principles.
On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?
Answer(s): C
Record retention requirements ensure regulatory access to data even after development is discontinued.21 CFR 312.62(c): "An investigator shall retain records... for 2 years after the date a marketing application is withdrawn or discontinued and FDA is notified."In this case, development was terminated 15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is 15 May 2021, but FDA requires records to be maintained until after the 2-year period ends. The earliest permissible destruction date is 16 May 2022 (C).Options A and B are premature; D (2034) is far beyond requirements.Thus, the correct answer is C (16 May 2022).
21 CFR 312.62(c) (Investigator record retention).21 CFR 312.57(c) (Sponsor record retention).
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