Beginning in April, clinical researchers will have a training opportunity for preparing and submitting data in compliance with the Study Data Tabulation Model (SDTM). The FDA-required data submissions standard was developed by the Clinical Data Interchange Standards Consortium (CDISC) in conjunction with solutions provider Clinical Trials & Surveys Corp. (C-TASC).
"Not many IT professionals understand what SDTM is," says C-TASC president Bruce Thompson, via email. "The most common misunderstanding is that a research group can write a standard program that will automatically convert all the data. In general, SDTM conversion is a process that will vary for each study."
The procedures taught in the course yield validated data that can be entered into JANUS, the FDA data warehouse, says Thompson. He adds, however, that the SDTM Implementation Guide, as written, allows submissions to be too generalized for rapid use by the regulator, which is setting harmonization standards that format the data more restrictively.
Attendees will see simulations of data conversions and can bring their own clinical data for use in class exercises. The training will include explanations of core procedures and data-preparation guidelines. Instructors will focus on software technology available to expedite data conversions. The $2,000 C-TASC training will run over two days at the company's Owings Mills, MD, facility, outside Baltimore, during the third week of each month.
C-TASC instructors are trained in preparing data using various techniques and involving data of various origins and stages of SDTM compliance. Currently, several large ETL (extract, transform, load) programming packages are available for data conversions. Among them are Informatica and Allora, says Thompson. "In addition, SAS and ORACLE programmers can successfully convert data by writing programs in these languages."
- here's the document summarizing the class (pdf)