Pinnacle 21

SDTM refers to the Study Data Tabulation Model. It’s the standardized format required in the pharmaceutical and clinical research industry to organize and present patient data from human clinical trials to regulatory authorities, like the Food and Drug Administration (FDA). In 2004, SDTM was declared as the required standard format for data submission in clinical research. Proving data in line with the SDTM structure ensures consistency and enables more efficient analysis and greater transparency in clinical research.

SDTM datasets, or Study Data Tabulation Model datasets, are tables of data that are produced in line with SDTM standards. SDTM is the required format for tabulation data submission to the FDA and PMDA. SDTM datasets contain information relating to clinical trial patients, including demographics, treatments, adverse reactions etc. Find out all you need to know about SDTM in our helpful blog >>

SDTM specifications describe how raw data is to be converted. They’re used by biostats programmers to convert data to the SDTM format. The process of developing SDTM datasets starts with identifying the required SDTM domains from your CRFs and raw data. Next, map the raw dataset variables (with a non-CDISC structure) to the relevant CDISC SDTM domain variables. That way, you’ll know which raw dataset will provide the data for your SDTM domain. Finally, list all the variables against each SDTM domain and describe how they should be programmed. Want to know more? Read our helpful best practice guide to CDISC SDTM Mapping >>