CRP Regulatory Compliance & Guidelines 2

Question 1

Under 21 CFR Part 11, which of the following is a requirement for electronic records used in clinical research?

Accepted Answer

Electronic records must be the exact equivalent of paper records and include audit trails

Answer

21 CFR Part 11 requires that electronic records be the equivalent of paper records and mandates audit trails to track data creation, modification, and deletion.

Question 2

The Declaration of Helsinki primarily applies to which type of research?

Accepted Answer

Medical research involving human subjects

Answer

The Declaration of Helsinki is a set of ethical principles by the World Medical Association governing medical research involving human subjects.

Question 3

A sponsor discovers a serious, unexpected adverse drug reaction during a clinical trial. Under FDA regulations, within what timeframe must an IND Safety Report (expedited) be submitted?

Accepted Answer

7 calendar days for fatal/life-threatening; 15 calendar days for others

Answer

FDA regulations require expedited IND Safety Reports within 7 days for fatal or life-threatening unexpected serious adverse reactions and within 15 days for other unexpected serious adverse reactions.

Question 4

Which regulation establishes the standards for Good Laboratory Practice (GLP) for nonclinical laboratory studies submitted to the FDA?

Accepted Answer

21 CFR Part 58

Answer

21 CFR Part 58 establishes Good Laboratory Practice regulations for nonclinical laboratory studies that support research or marketing permits for FDA-regulated products.

Question 5

What does the concept of 'research misconduct' include under federal regulations (42 CFR Part 93)?

Accepted Answer

Fabrication, falsification, and plagiarism in proposing, performing, reviewing, or reporting research

Answer

Federal regulations define research misconduct as fabrication, falsification, or plagiarism (FFP) in proposing, performing, reviewing, or reporting research results.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Regulatory Compliance & Guidelines 2