CCDM Data Standards & Database Design 5 — Questions and Answers
Question 1: Which CDISC standard provides the framework for electronic data capture (EDC) systems using XML-based data exchange?
- SDTM
- ADaM
- ODM (Operational Data Model) (Correct answer)
- SEND
Correct answer: ODM (Operational Data Model)
The CDISC Operational Data Model (ODM) is an XML-based standard for exchanging and archiving clinical and translational research data across EDC systems.
Question 2: When designing a clinical database, what is the primary reason to separate 'visit date' from 'assessment date' as distinct fields?
- To reduce database storage requirements
- Because assessments may occur outside of scheduled visits, and recording both dates maintains accuracy (Correct answer)
- To comply with SDTM naming conventions for date variables
- Because regulatory agencies require two date fields for all records
Correct answer: Because assessments may occur outside of scheduled visits, and recording both dates maintains accuracy
Assessments may occur on different dates than the visit (e.g., lab samples sent to a central lab), so capturing both dates maintains accurate temporal records.
Question 3: What is the significance of the STUDYID variable being consistent across all SDTM domains in a submission?
- It determines the order in which datasets are reviewed by the FDA
- It links all datasets to the same study and enables cross-domain data integration (Correct answer)
- It is required only in the DM domain and referenced elsewhere
- It encrypts subject identifiers for privacy compliance
Correct answer: It links all datasets to the same study and enables cross-domain data integration
A consistent STUDYID across all domains ensures that data from different domains can be reliably linked and integrated during regulatory review.
Question 4: A database designer chooses to use surrogate keys instead of natural keys as primary identifiers. What is the MAIN benefit of this approach in clinical data management?
- Surrogate keys are always shorter, saving storage space
- Surrogate keys are system-generated, immune to changes in natural data attributes, and prevent integrity issues when source identifiers change (Correct answer)
- Surrogate keys automatically enforce HIPAA compliance
- Surrogate keys eliminate the need for audit trail mechanisms
Correct answer: Surrogate keys are system-generated, immune to changes in natural data attributes, and prevent integrity issues when source identifiers change
Surrogate keys are stable, system-generated identifiers that remain unchanged even if natural identifiers (like subject IDs) are corrected or reassigned.
Question 5: In SDTM, the --ORRES variable stores the original result as collected. What is the purpose of the corresponding --STRESC variable?
- To store the sponsor-defined normal range for the result
- To hold the standardized result in character format, allowing consistent representation for both numeric and text results (Correct answer)
- To capture the units in which the result was measured
- To indicate whether the result was within the normal reference range
Correct answer: To hold the standardized result in character format, allowing consistent representation for both numeric and text results
--STRESC stores the original result converted to a standard character format, facilitating consistent interpretation across mixed numeric and text result types.
Question 6: Which principle of database design ensures that the same data is not stored in multiple locations, reducing update anomalies?
- Data replication
- Data normalization (Correct answer)
- Data partitioning
- Data masking
Correct answer: Data normalization
Data normalization organizes data to minimize redundancy, ensuring each piece of information is stored in only one place and reducing the risk of inconsistencies.
Question 7: When performing a database lock for a clinical trial, which activity should be completed BEFORE the lock is executed?
- Statistical analysis of primary endpoints
- Resolution of all outstanding queries and sign-off by data management and clinical operations (Correct answer)
- Archiving all CRF images to long-term storage
- Submission of the CSR to the FDA
Correct answer: Resolution of all outstanding queries and sign-off by data management and clinical operations
All outstanding data queries must be resolved and relevant stakeholders must provide sign-off before a database lock to ensure data integrity at the time of analysis.
CCDM Data Standards & Database Design 5
Which CDISC standard provides the framework for electronic data capture (EDC) systems using XML-based data exchange?