Data Standards & Database Design 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 Standards & Database Design flashcards as text
In ADaM dataset design, what is the key distinguishing feature of a BDS (Basic Data Structure) dataset?
Answer: One or more records per subject per analysis parameter per timepoint
ADaM BDS datasets have one or more records per subject per analysis parameter per timepoint, supporting a wide variety of statistical analyses.
What is the purpose of the SUPPQUAL (Supplemental Qualifiers) dataset in SDTM?
Answer: To hold additional non-standard variables that cannot be accommodated in the parent domain
SUPPQUAL datasets store additional qualifier variables for a parent domain when standard domain variables are insufficient.
When designing a database edit check, what is the difference between a 'range check' and a 'cross-field check'?
Answer: Range checks verify a single value against defined limits; cross-field checks compare two or more fields for consistency
A range check validates that a single field value falls within predefined acceptable bounds, while a cross-field check verifies logical relationships between multiple fields.
Which MedDRA hierarchy level is used as the primary endpoint coding level in most adverse event analyses?
Answer: Preferred Term (PT)
The Preferred Term (PT) is the primary level for MedDRA coding in adverse event analyses, as it represents a distinct medical concept.
A study team finds that the same adverse event is coded differently across two clinical sites. Which root cause is MOST likely?
Answer: Inconsistent application of coding dictionaries or versions
Inconsistent coding occurs when different sites use different versions of MedDRA or apply coding conventions differently without centralized oversight.
In database design for clinical trials, what is the primary advantage of using a metadata-driven approach?
Answer: It allows the system to generate forms, edits, and reports from a central specification, reducing hard-coding
A metadata-driven system uses a central repository of specifications to dynamically drive form generation, edit checks, and reporting, improving consistency and efficiency.
What is the role of the DEFINE-XML document in a regulatory submission package?
Answer: A machine-readable metadata file describing all datasets, variables, and controlled terminology in the submission
Define-XML (based on CDISC ODM) provides a comprehensive, machine-readable data dictionary for all datasets in a regulatory submission.