Quality Assurance & Improvement Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance & Improvement flashcards as text
In clinical research quality management, 'critical data' as defined by ICH E6(R2) refers to data that:
Answer: Directly affects subject safety decisions or study conclusions
Critical data are those whose integrity is essential to subject safety evaluation or to the key scientific conclusions of the trial, warranting the most rigorous oversight.
Which action best demonstrates a culture of quality at a clinical research site?
Answer: Proactively self-identifying and reporting issues before external detection
Proactive self-identification and transparent reporting of issues indicates a mature quality culture where staff feel safe raising concerns before external discovery.
The purpose of a Trial Master File (TMF) is to:
Answer: Contain essential documents that allow reconstruction and evaluation of trial conduct
The TMF is a collection of essential documents that individually and collectively permits evaluation of the conduct of the trial and the quality of the data produced.
When performing a gap analysis for GCP compliance, the investigator is comparing:
Answer: Current site practices against regulatory and protocol requirements
A gap analysis identifies discrepancies between where the site currently operates and where it needs to be according to applicable regulations and protocol requirements.
A sponsor implements centralized statistical monitoring (CSM) primarily to:
Answer: Detect data anomalies and potential fraud across multiple sites using aggregate data patterns
CSM analyzes aggregate data across sites to detect unusual patterns, potential fabrication, or systematic errors that on-site monitoring alone might miss.
During an inspection, an FDA investigator notes that a site's delegation log was not updated when a new sub-investigator joined mid-trial. This finding represents:
Answer: A documentation deficiency indicating inadequate oversight of trial personnel
Delegation logs must document all personnel to whom the PI delegates trial tasks, and failure to keep this current is a GCP deficiency that indicates inadequate oversight.
Which element is REQUIRED in a corrective action plan following a significant audit finding?
Answer: Target completion dates for each corrective action
Effective corrective action plans must include specific actions, responsible parties, and target completion dates so that progress can be tracked and verified.