CCDM Regulatory Requirements 2

Question 1

Under 21 CFR Part 11, which technical control is specifically required for electronic signatures used in clinical data systems?

Accepted Answer

A unique identifier combined with a password or biometric

Answer

21 CFR Part 11 requires electronic signatures to consist of at least two distinct identification components, such as a unique identifier combined with a password or biometric.

Question 2

Which ICH guideline specifically addresses the statistical principles for clinical trials, relevant to data management planning?

Accepted Answer

ICH E9

Answer

ICH E9 covers statistical principles for clinical trials, guiding how clinical data should be collected, handled, and analyzed.

Question 3

When a sponsor makes a change to an already-approved protocol, what regulatory document must be submitted to the IRB before implementing the change?

Accepted Answer

A protocol amendment

Answer

Protocol amendments must be submitted to and approved by the IRB before any changes are implemented, unless they are necessary to eliminate immediate hazards.

Question 4

According to FDA regulations, how long must a sponsor retain essential clinical trial records after the marketing application is approved or discontinued?

Accepted Answer

2 years

Answer

FDA 21 CFR 312.62 requires sponsors to retain records for at least 2 years after a marketing application is approved, or 2 years after the IND is withdrawn if no application is filed.

Question 5

Which regulation governs the protection of individually identifiable health information in the context of clinical research in the US?

Accepted Answer

HIPAA Privacy Rule

Answer

The HIPAA Privacy Rule establishes standards for the protection of individually identifiable health information, including in clinical research settings.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Regulatory Requirements 2