Company datamanagement365 limited
Categories 12 Channel ECG Machine
Update 2020-01-10 18:59:34
ICP License Issued by the Chinese Ministry
18 November 2019 News
SDTM (Study Data Tabulation Model) is a standard for Study Data Submission developed by non-commercial industry stakeholders CDISC (Clinical Data Interchange Standards Consortium) . 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. 
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  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!
and some pros just haven’t been discovered implemented yet!
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