CRP Risk Management & Quality Assurance 5

Question 1

Under 21 CFR Part 312, sponsors must report unexpected fatal or life-threatening suspected adverse reactions (IND safety reports) within:

Accepted Answer

7 calendar days

Answer

FDA regulations require sponsors to report unexpected fatal or life-threatening suspected adverse reactions within 7 calendar days of initial receipt of information.

Question 2

What is 'residual risk' in research quality management?

Accepted Answer

Risk that remains after controls and mitigation strategies have been applied

Answer

Residual risk is the remaining level of risk after all planned mitigation and control measures have been implemented, which must be evaluated against risk tolerance.

Question 3

Which GCP requirement is addressed by maintaining a 'delegation log' at a clinical research site?

Accepted Answer

Documenting which qualified staff members are authorized to perform specific trial tasks

Answer

A delegation log documents that the PI has assigned specific trial-related tasks only to qualified and trained staff members, ensuring accountability and GCP compliance.

Question 4

A pharmaceutical sponsor implements an 'audit trail' in its electronic data capture system. This feature primarily supports which quality objective?

Accepted Answer

Ensuring data traceability, integrity, and detection of unauthorized changes

Answer

An audit trail creates a secure, time-stamped record of all data entries and changes, enabling reconstruction of events and detection of any unauthorized alterations to research data.

Question 5

In risk-based quality management (RBQM), 'critical data' and 'critical processes' are identified primarily based on:

Accepted Answer

Their potential impact on participant safety and the reliability of trial results

Answer

RBQM defines critical data and processes as those whose integrity is essential for protecting participants and ensuring the validity of study conclusions.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Risk Management & Quality Assurance 5