Data Validation 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 Data Validation flashcards as text
In an EDC system, what is the function of a 'hard stop' edit check?
Answer: It prevents the user from saving the record until the invalid entry is corrected
A hard stop edit check prevents the data entry operator from saving or advancing past a field until the entered value satisfies the validation rule.
What is the key difference between a 'soft' edit check and a 'hard' edit check in clinical data management?
Answer: Soft checks issue a warning but allow data saving; hard checks block saving until resolved
Soft edit checks alert the user to a potential issue but allow the record to be saved with an override or explanation, while hard edit checks prevent saving until the error is corrected.
Which document formally describes all programmed edit checks for a clinical trial database?
Answer: Edit Check Specifications (ECS)
The Edit Check Specifications document formally defines the logic, parameters, and expected behavior of all programmed validation checks in the clinical database.
Laboratory normal ranges used in clinical trial edit checks should ideally be sourced from which location?
Answer: The central laboratory providing services for the trial
Normal reference ranges should come from the specific central laboratory performing the assays, as ranges vary by lab methodology, equipment, and population.
What is the purpose of a 'derivation check' in clinical data validation?
Answer: To confirm that derived or calculated fields are computed correctly from their source variables
A derivation check validates that programmatically calculated fields, such as BMI from height and weight, produce the mathematically correct result.
When a query is issued to a clinical site regarding a data discrepancy, what should the site's response include?
Answer: A correction or clarification with appropriate source document justification
Sites must respond to queries with a data correction or clinical clarification supported by source documentation to maintain an auditable data trail.
Which CDISC standard is most directly used to define the structure and terminology of clinical data for regulatory submission after validation?
Answer: SDTM
The Study Data Tabulation Model (SDTM) defines the standard structure and terminology for organizing collected clinical trial data submitted to regulatory agencies like the FDA.