Quality Control & Regulatory Compliance Flashcards
7 cards from real CCDM 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 Control & Regulatory Compliance flashcards as text
A data cleaning plan (DCP) for a Phase III trial should primarily be developed at which stage of the data management lifecycle?
Answer: Before the study begins, concurrently with protocol and CRF development
The data cleaning plan should be developed before the study begins so that QC strategies, edit checks, and query thresholds are defined prospectively rather than reactively.
Which of the following is an example of a preventive quality control measure in clinical data management?
Answer: Implementing automated range checks and logical edit checks during eCRF design
Automated range checks and logical edit checks during eCRF design are preventive controls because they prevent erroneous data from being entered in the first place.
In risk-based quality management (RBQM), what is the primary purpose of defining Key Risk Indicators (KRIs)?
Answer: To provide early warning signals of quality issues that could impact subject safety or data integrity
KRIs serve as early warning signals, allowing sponsors to detect emerging quality or safety issues and intervene before they become systemic problems.
A sponsor's data management team receives the database lock checklist. Which item, if incomplete, is the most critical reason to delay database lock?
Answer: Outstanding critical protocol deviation queries that could affect the primary endpoint dataset
Outstanding queries on critical data that could affect the primary endpoint dataset represent an unresolved data quality issue that must be resolved before database lock to ensure analysis integrity.
Which regulatory requirement mandates that clinical trial data submitted to the FDA must be in a standardized electronic format?
Answer: 21 CFR Part 312.23 with CDISC SDTM/ADaM standards mandated for NDA/BLA submissions
FDA regulations under 21 CFR Part 312 combined with FDA guidance require CDISC SDTM and ADaM formats for electronic data submission in NDA and BLA applications.
During a quality audit of an eClinical system, it is discovered that user access privileges were not deactivated for three staff members who left the organization 6 months ago. Which regulation is most directly violated?
Answer: 21 CFR Part 11 (Electronic Records; Electronic Signatures)
21 CFR Part 11 requires controls to ensure that only authorized individuals can access electronic records and systems, and access must be revoked when individuals are no longer authorized.
What distinguishes a 'validation' from a 'verification' in the context of clinical data management system qualification?
Answer: Validation confirms the system meets user requirements; verification confirms it was built according to design specifications
Validation (are we building the right thing?) confirms a system meets user requirements and intended use, while verification (are we building it right?) confirms the system was built according to its design specifications.