SDTM Checker

Mission

Entimo's SDTM and ADaM checkers are validated solutions which verify compliance of clinical data with CDISC models. These tools inspect structure, content, terminology and value level metadata, run officially published and additional checks and provide detailed reports including result statistics.

Benefits

1. Validated tools for proven results

2. Simple use

3. Metadata driven configuration

4. Easy integration of custom checks

4. Centralized and secure repository for rules, datasets, reports and issues

5. Early issue detection

6. No define.xml required

7. Detailed reports down to a data cell

What's new?

Entimo continuously develops and improves its products. The current release of the SDTM/ADaM checker contains the following enhancements:

  • New checks
  • New domains supported
  • Checks for NCI controlled terminology
  • Extended standard call program

 

Contact us for more information about Entimo's products, release information and roadmaps.

SDTM/ADaM Checker Highlights

Standard and Custom Check Rules

The wide spectrum of built-in SDTM and ADaM checks covers not only officially published, but also includes many additional checks: Checks of data formats, controlled terminology and against external dictionaries such as MedDRA and WHO Drug, numerous value level checks and checks of supplemental qualifiers ensure maximum consisency of your data. Driven by metadata and configurable, the checkers are able to incorporate custom domains and user checks written in SAS. Intra-domain, cross-domain and cross-model checks are executed for SDTM/ADaM as far as possible from the very first available domain thus supporting prompt QC. Results of additional checks are included in the main check report.

Overview report

Overview report

 

Results and Reports

Test results are presented in different formats for effortless analysis. Detailed reports provide an overview of checked domains with user and time stamps, links to used controlled terminology, check details with messages, and statistics. Identified quality issues can be tracked down to a cell and are reported according to severity classification. One glance at the statistics section is enough to assess check results: Detailed statistics include the results of standard and user checks per domain as well as check summaries. Interactive report allows easy sorting and filtering of messages, severities and other test results.

Detailed report

Detail report


    Download the fact sheet: check tools