Risk Management & Quality Assurance Flashcards
7 cards from real CRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Management & Quality Assurance flashcards as text
Under 21 CFR Part 312, sponsors must report unexpected fatal or life-threatening suspected adverse reactions (IND safety reports) within:
Answer: 7 calendar days
FDA regulations require sponsors to report unexpected fatal or life-threatening suspected adverse reactions within 7 calendar days of initial receipt of information.
What is 'residual risk' in research quality management?
Answer: Risk that remains after controls and mitigation strategies have been applied
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.
Which GCP requirement is addressed by maintaining a 'delegation log' at a clinical research site?
Answer: Documenting which qualified staff members are authorized to perform specific trial tasks
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.
A pharmaceutical sponsor implements an 'audit trail' in its electronic data capture system. This feature primarily supports which quality objective?
Answer: Ensuring data traceability, integrity, and detection of unauthorized changes
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.
In risk-based quality management (RBQM), 'critical data' and 'critical processes' are identified primarily based on:
Answer: Their potential impact on participant safety and the reliability of trial results
RBQM defines critical data and processes as those whose integrity is essential for protecting participants and ensuring the validity of study conclusions.
What is the purpose of an 'interim analysis' in a long-term clinical study from a risk management perspective?
Answer: To assess accumulating efficacy and safety data and enable early stopping if needed
Interim analyses allow early stopping for benefit, harm, or futility, reducing participant exposure to inferior or harmful treatments while managing statistical error rates.
Which practice best demonstrates proactive quality management in clinical research compared to reactive quality management?
Answer: Using risk assessments to identify and mitigate potential problems before they occur
Proactive quality management uses prospective risk identification and mitigation to prevent problems, whereas reactive approaches respond to issues only after they arise.