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
Click
here
to download this page as a flyer.
|
|
Further Info
Download
Flyer
Request more info about SDTM Checker
here...
Learn more about
entimo's solutions in our
case studies
here...
|