Database Management 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 Database Management flashcards as text
What is the significance of 'metadata' in a clinical trial database?
Answer: It describes the structure, context, and properties of the data stored in the database
Metadata in a clinical trial database describes the data itself — including field names, data types, validation rules, and relationships — providing context for the actual collected data.
In clinical database validation, what is the purpose of a 'traceability matrix'?
Answer: To link user requirements to test cases, demonstrating that all requirements have been tested
A traceability matrix maps each user requirement to corresponding test cases, ensuring every requirement has been tested and verified during database validation.
What is the difference between a 'hard lock' and a 'soft lock' in clinical trial database management?
Answer: A soft lock restricts editing pending query resolution; a hard lock prevents all modifications after final clean
A soft lock prevents data changes until outstanding queries are resolved, while a hard lock permanently freezes all data after the database has been fully cleaned and reviewed.
Which CDISC standard is used for the exchange of individual patient data between sponsors and regulatory agencies, specifying dataset metadata?
Answer: ODM (Operational Data Model)
The CDISC ODM (Operational Data Model) is an XML-based standard for the interchange of clinical data and metadata between different systems and organizations.
In a clinical EDC system, what is the function of a 'visit schedule' configuration?
Answer: To define which CRF pages and data fields are available or required at each study visit
A visit schedule configuration in an EDC system defines which CRF modules and fields are presented, required, or conditionally available at each protocol-specified visit.
What is 'data warehousing' in the context of clinical development programs?
Answer: A system for integrating and storing large volumes of data from multiple studies for cross-study analysis
A clinical data warehouse integrates data from multiple studies and sources into a central repository, enabling cross-study analysis, trend identification, and portfolio-level reporting.
Which action is most appropriate when a discrepancy is found between source document data and EDC data during site monitoring?
Answer: A data query should be raised so the site can review and correct the discrepancy with an audit trail
When a discrepancy is identified, a formal query should be raised so the site can investigate and correct the data in the EDC system with a documented audit trail, preserving data integrity.