SCDM Regulatory Compliance and GCP 1 — Questions and Answers
Question 1: Which ICH guideline specifically addresses Good Clinical Practice standards for clinical trials?
- ICH E6 (Correct answer)
- ICH E2A
- ICH E9
- ICH Q10
Correct 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.
Question 2: Under FDA 21 CFR Part 11, which of the following is required for electronic records to be considered legally equivalent to paper records?
- Audit trails that capture date, time, and operator (Correct answer)
- Paper backup copies of all records
- Manual signature on printed copies
- Weekly export to external storage
Correct 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.
Question 3: What is the primary purpose of a Data Management Plan (DMP) in a clinical trial?
- To describe all data management processes and responsibilities (Correct answer)
- To list all investigators on the trial
- To document the statistical analysis methodology
- To define the patient recruitment strategy
Correct 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.
Question 4: Which regulation governs the protection of human subjects in US federally funded research?
- 45 CFR Part 46 (the Common Rule) (Correct answer)
- 21 CFR Part 312
- ICH E6 R2
- FDA 21 CFR Part 11
Correct 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.
Question 5: What does 'ALCOA' stand for in the context of data integrity?
- Attributable, Legible, Contemporaneous, Original, Accurate (Correct answer)
- Authorized, Logged, Controlled, Organized, Audited
- Accurate, Legal, Consistent, Objective, Available
- Attributed, Licensed, Categorized, Observed, Archived
Correct 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.
Question 6: A sponsor requires that all data corrections include the original value, new value, date, initials, and reason. This practice ensures compliance with which principle?
- ALCOA data integrity standards (Correct answer)
- FDA Adverse Event Reporting
- IRB submission requirements
- HIPAA de-identification rules
Correct answer: ALCOA data integrity standards
Documenting original values, corrections, dates, initials, and reasons fulfills the ALCOA requirements of attributability and traceability for data integrity.
SCDM Regulatory Compliance and GCP 1
Which ICH guideline specifically addresses Good Clinical Practice standards for clinical trials?