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
Which database validation check ensures that a date entered falls within the allowable study window for a visit?
Answer: Range check
A range check validates that a value, such as a visit date, falls within a predefined acceptable range.
What is the purpose of a data lock in clinical trial database management?
Answer: To prevent further changes to the database after clean data is confirmed
A database lock prevents modifications to data after the data cleaning process is complete and data quality is confirmed, preserving data integrity for analysis.
In a relational database used for clinical trials, what does a foreign key enforce?
Answer: Referential integrity between two tables
A foreign key enforces referential integrity by ensuring that a value in one table corresponds to a valid entry in another related table.
Which type of database design is most commonly used in clinical data management systems for structured trial data?
Answer: Relational database
Relational databases are most commonly used in clinical data management because they organize data into tables with defined relationships, supporting complex queries and data integrity.
What is a data dictionary in the context of clinical trial database management?
Answer: A document describing the structure, content, and format of the database
A data dictionary documents the structure, content, format, and validation rules for each field in the clinical trial database.
When performing database reconciliation between two sources (e.g., EDC and safety database), what is the primary goal?
Answer: To identify and resolve discrepancies between the two datasets
Database reconciliation aims to identify and resolve any discrepancies between two data sources to ensure consistency and accuracy.
Which 21 CFR Part 11 requirement directly applies to clinical trial databases in the US?
Answer: Ensuring electronic records and electronic signatures are trustworthy and equivalent to paper
21 CFR Part 11 establishes criteria under which electronic records and electronic signatures are considered trustworthy and legally equivalent to paper records.