Hands-on training for SDTM conversion

March 10, 2010 – 10:50 am by Colette Pilkus

With FDA’s adoption of a standardized data file format for clinical data submissions, clinical researchers need to know these new standards when collecting and preparing their clinical trial data for submission, since it is the only way that clinical data can be submitted. The ultimate purpose of using the Study Data Tabulation Model (SDTM) is to have standardized and harmonized data that will allow FDA to do cross-study data analysis.

FDA is creating a data warehouse called Janus that requires this standardized format. Janus, which was piloted in 2006, will allow FDA to pick up adverse events and to look for genetic sub diseases within disease classes to be able to tailor the various approved treatments for particular types of disease. The data warehouse also allows FDA to look for very rare adverse events that can only be seen once several studies viewed together.

FDA is busy converting legacy data for inclusion in Janus. SDTM conversion involves taking collection data and converting it into warehouse data, which means the data is reorganized into 18 different domains such as demographics, adverse events, and clinical findings. FDA developed a standardized way to put age, race, and gender into the demographics domain, which is a way to classify adverse events and put them into the adverse event domain and a way to put all laboratories into the laboratory domain in a way such that they can very quickly identify and perform data analysis they want to do across a large number of studies.

Since 2008, Clinical Trials & Surveys Corp. (C-TASC) has worked with FDA to develop a standardized methodology for creating harmonized SDTM data files for submissions. “To date we’ve done over 60 data sets that have been prepared to be put into Janus and are in the process of being put in now,” says Bruce Thompson, Ph.D., president and chairman of the board at C-TASC.

Because there are many challenges in the SDTM conversion process, starting in April 2010, C-TASC will offer monthly two-day training courses to teach biotechnology professionals how to prepare and submit data in compliance with the Clinical Data Interchange Standards Consortium’s SDTM.

“Submitting Clinical Trials Data to the FDA: A Practicum on SDTM” will be held the third week of each month at C-TASC’s headquarters. The classes will include explanations of core procedures, steps, and guidelines for preparing data for FDA submission. Instructors will discuss surrounding issues and innovations in the field with a focus on software technology to expedite conversions of data into an FDA/SDTM-compliant format.

“The classes are not designed to be review classes about what SDTM implementation guide covers,” Dr. Thompson says. “We assume that people will have a good fundamental understanding of the implementation guide. What we’re going to do is provide a hands-on laboratory practicum that will actually teach [clinical researches] how to pivot data, format data, and transform data in such a way that we can actually get into the Janus data warehouse. One of the major differences of our class versus others is we’re going to connect to their databases; they can bring a sample database in or we will provide them one, and they will actually be working with us to learn how to make those transformations and modifications of their data in order to get them into Janus.”

Tags: Clinical Data Interchange Standards Consortium, Clinical Trials & Surveys Corp., FDA, Study Data Tabulation Model