Classes in FDA-Acceptable Data Conversion–Now Available
Because the FDA was spending excessive amounts of time converting clinical trials data into a standard format, they now require all data to be submitted in the Study Data Tabulation Model (SDTM) format. To assist you with this, C-TASC is offering classes to teach your staff how to convert your data into the FDA acceptable format.
The two-day class will be offered the third week of every month at C-TASC’s secure facility located near Baltimore in Owings Mills, Maryland. Instructors are experienced in all types of data conversion, and will demonstrate a data conversion simulation in class. Participants will have the opportunity to work on converting their own data during in-class exercises.
C-TASC is uniquely qualified to teach data conversion classes, as we have worked with the FDA since October 2008 to develop procedures to receive, process and analyze clinical trial data submitted for FDA approval. We have developed a method for high speed processing of disparate data sets into SDTM format, and continue to work with the FDA to further refine the process.
A summary of the class can be downloaded as a pdf document here.
Click here jgarcia@c-tasc.com to request additional information on SDTM Data Conversion Classes, or call 410-435-0663.
- Any Data to SDTM IG 3.1.2
- Data Validation
- Define.xml Creation
- Integrity Checks for FDA JANUS
