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18 November 2019 News

SDTM: how we deal with it

SDTM (Study Data Tabulation Model) is a standard for Study Data Submission developed by non-commercial industry stakeholders CDISC (Clinical Data Interchange Standards Consortium) [1]. In other words, this is a way how data should be submitted to regulatory agencies. 

 

You may imagine that data should be collected in eCRF, exported in Excel and that's it. However, FDA accepts Study data only in SDTM structure since December 2016. [2] 

 

The list of challenges may seem endless:

 

        Non-standard eCRF structure

        eCRF versions update

        Characters other than Latin entered in free-text fields

        Study datasets structure with dozens of specifics written in small letters

        Study datasets content with missing data for variables

        Study datasets validation

        Pinnacle 21 [3] report help!

        Medical coding dictionaries versioning

        Data cleaning issues

        Data standardization issues

        Trial Summary dataset

        Protocol Deviations dataset and how to locate it

        Variable length exceeds over 200 symbols it was not like that yesterday omg another script update

        Final Pinnacle 21 report

           

 

            MainEDC System has a built-in SDTM constructor which allows to generate SDTM datasets. Our DM team is CDISC-certified and can create SDTM datasets from your eCRF built in our System!

           

Pros:

  1. Datasets structure can be configured and tested prior to the data collection activities
  2. Datasets are available for direct download in the System 24/7 and can be used for contemporaneous data review throughout the study - save your time and money and be ICH GCP E6(R2) compliant!
  3. Datasets are available in the System for direct download afterwards, so historical exports are always available
  4. Datasets structure can be easily adjusted after eCRF updates
  5. Complex derivation algorithms are supported (e.g. the EPOCH variable)
  6. Transparent laboratory data standardization with standardization quotients
  7. Reference ranges uploaded from the Laboratories module
  8. Protocol Deviations tracker in the System built-in module, quick integration with SDTM constructor
  9. SUPP-- datasets seem to be miles away from parent dataset? Dataset review mode provides consolidated dataset export file
  10. SUPP-- datasets can be generated in packs
  11. Integration with IWRS module - blinded/ unblinded treatment arm data, drug dispensing/replacement records, etc., etc. Are you following how much you saved between points 1 and 11?
  12. Need a custom SDTM dataset that has never existed before? Generate it in the System (a chance to carve your initials in stone)!
  13. External data import always available in SDTM dataset: see your external data from questionnaires, MRI reading, Central lab, Pharmacokinetics measurements and so on
  14. Download dataset in *.xpt format and run it through Pinnacle 21 (for various purposes) at any time
  15. Perform test study data submission to FDA at any point
  16. Ensure data traceability - from CDASH compliant eCRF to SDTM datasets ready for submission
  17. SDTM basic mapping from eCRF configuration tool and you trace all the paths in this forest
  18. Generate datasets months before final database cutoff and use it to create Define.xml in advance
  19. All you need is SDTM standard and training on our SDTM constructor
  20. SDTM constructor can be used to generate custom listings whenever necessary

 

and some pros just havent been discovered implemented yet!

 

Cons:

  1. You have never used it before

 

References:

[1] https://www.cdisc.org/

[2]https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources

[3] https://www.pinnacle21.com/



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