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
In CDISC standards, what does the SDTM model primarily define?
Answer: The format for submitting clinical trial data to regulatory agencies
The Study Data Tabulation Model (SDTM) defines a standard structure for organizing and formatting clinical study data for submission to regulatory agencies like the FDA.
What is a primary key in a clinical trial database table?
Answer: A unique identifier for each record within a table
A primary key is a unique identifier assigned to each record in a database table, ensuring no two records have the same key value.
Which of the following best describes a 'flat file' in the context of clinical data exchange?
Answer: A simple text-based file where data is organized in rows and columns without relational structure
A flat file is a simple text-based file (such as CSV or TXT) that stores data in a two-dimensional format without the relational structure of a database.
When a clinical database undergoes a significant amendment mid-study, what is required before implementation?
Answer: Revalidation and documentation of the changes according to change control procedures
Any significant changes to a validated clinical database must follow formal change control procedures, including documentation, impact assessment, revalidation, and approval before implementation.
What is a 'derived variable' in clinical database management?
Answer: A variable whose value is computed from other collected data rather than directly entered
A derived variable is calculated from other variables in the database (e.g., BMI derived from height and weight) rather than being directly entered by site staff.
In the context of clinical trials, what is the purpose of a 'query management system'?
Answer: To track, issue, and resolve data clarification requests between data management and sites
A query management system tracks all data clarification requests (DCFs/queries) issued to investigative sites and documents their resolution to ensure data accuracy.
Which regulatory guidance emphasizes risk-based approaches to data quality management in clinical trials?
Answer: ICH E6(R2) Good Clinical Practice
ICH E6(R2) GCP guidance emphasizes a risk-based approach to clinical trial conduct and data quality management, focusing resources on critical data and processes.