SDTM Checker

Three reasons to use entimo’s SDTM Checker:

1. Continuous quality control: Stand-alone SAS program allows mapping specialists to perform independently and continuously data validation from the first steps

2. Comprehensive and extendible: Standard conformance checks can be easily extended and enhanced with user-specific checks

3. Follows your processes: SDTM Checker can be integrated into your specific workflow and helps automate data validation tasks
 

Entimo’s SDTM Checker validates clinical data against metadata, inspects structure and data consistency as well as controls compliance with CDISC SDTM.

SDTM Domain Metadata
Entimo provides a full set of SDTM domain templates. The standard domain definitions can be used at once for data quality checks or easily adjusted to incorporate sponsor-specific (SDTM+) data models.

SDTM Datasets
SDTM domain datasets to be checked are comfortably specified as program parameters. Once defined, the parameter sets can be used for repeated runs with no additional effort.

Check Rules
Wide spectrum of built-in checks include existence and consistency checks of required and expected data elements, data format as well as usage of controlled terminology. Check rules can be easily extended and updated along with model changes (e.g. new SDTM versions).
User is able to integrate customer specific checks. Additional check program is addressed via parameter and is automatically executed during SDTM Checker’s runs. Results of additional checks are included into the main check report.

Check Report
Identified quality issues are reported according to severity classification (high–medium-low). Thus the issue list can be easily communicated to the sponsor. The check report is stored as a SAS dataset for post-processing.

entimICE^® DARE Integration
When running the SDTM Checker within entimo’s Integrated Clinical Environment (entimICE DARE), you benefit from:

• Drag-and-drop GUI support for easy check execution and parameter definition

• Repeatable and reproducible runs

• Full-fledged traceability of program executions

• Scheduling service for SDTM Checker’s runs

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