SCDM Regulatory Compliance and GCP

Question 1

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

Accepted Answer

ICH E6

Answer

ICH E2A

Answer

ICH E9

Answer

ICH Q10

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?

Accepted Answer

Audit trails that capture date, time, and operator

Answer

Paper backup copies of all records

Answer

Manual signature on printed copies

Answer

Weekly export to external storage

Question 3

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

Accepted Answer

To describe all data management processes and responsibilities

Answer

To list all investigators on the trial

Answer

To document the statistical analysis methodology

Answer

To define the patient recruitment strategy

Question 4

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

Accepted Answer

45 CFR Part 46 (the Common Rule)

Answer

21 CFR Part 312

Answer

ICH E6 R2

Answer

FDA 21 CFR Part 11

Question 5

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

Accepted Answer

Attributable, Legible, Contemporaneous, Original, Accurate

Answer

Authorized, Logged, Controlled, Organized, Audited

Answer

Accurate, Legal, Consistent, Objective, Available

Answer

Attributed, Licensed, Categorized, Observed, Archived

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?

Accepted Answer

ALCOA data integrity standards

Answer

FDA Adverse Event Reporting

Answer

IRB submission requirements

Answer

HIPAA de-identification rules