Regulatory Compliance and GCP Flashcards

Which ICH guideline specifically addresses Good Clinical Practice standards for clinical trials?

Answer: ICH E6

ICH E6 (R2) is the international guideline that defines Good Clinical Practice standards for the design, conduct, and reporting of clinical trials.

Under FDA 21 CFR Part 11, which of the following is required for electronic records to be considered legally equivalent to paper records?

Answer: Audit trails that capture date, time, and operator

21 CFR Part 11 requires audit trails that capture the date and time of each entry and who made it, ensuring the integrity and traceability of electronic records.

What is the primary purpose of a Data Management Plan (DMP) in a clinical trial?

Answer: To describe all data management processes and responsibilities

A DMP outlines all data management processes, tools, responsibilities, and timelines to ensure consistent, compliant data handling throughout the trial.

Which regulation governs the protection of human subjects in US federally funded research?

Answer: 45 CFR Part 46 (the Common Rule)

45 CFR Part 46, known as the Common Rule, establishes federal standards for the protection of human research subjects in studies funded by US federal agencies.

What does 'ALCOA' stand for in the context of data integrity?

Answer: Attributable, Legible, Contemporaneous, Original, Accurate

ALCOA defines five data integrity attributes: Attributable, Legible, Contemporaneous, Original, and Accurate, forming the basis for GCP-compliant data recording.

A sponsor requires that all data corrections include the original value, new value, date, initials, and reason. This practice ensures compliance with which principle?

Answer: ALCOA data integrity standards

Documenting original values, corrections, dates, initials, and reasons fulfills the ALCOA requirements of attributability and traceability for data integrity.