SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.

The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. On July 21, 2004, SDTM was selected as the standard specification …

Mar 12, 2024 · What is SDTM in clinical trials? The Study Data Tabulation Model (SDTM) is one of the most important CDISC data standards. It’s a framework used for organizing data …

Jul 29, 2024 · SDTM, initially known as Submission Data Model (SDM), was developed by the CDISC Submission Data Standards (SDS) Team in 2004. The SDS Team is comprised of …

MM227 Does SDTM Validation Really Require Double Programming? Sunil Gupta, Gupta Programming; Tomás Sabat Stofsel, Verisian. PO235 Guidance from the FDA authored …

SDTM is one of the required standards that sponsors must use as specified in the FDA’s Data Standards Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions. For more …

Jan 3, 2026 · SDTM stands for Study Data Tabulation Model. It is a global standard used to structure and present clinical trial data in a predefined format. Regulatory authorities such as …

According to CDISC: SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.

Standardized under the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), these datasets are crucial for regulatory submissions but require significant programming …

After this training you will have a High Level understanding of the concepts behind Mapping Data or Standardizing Data Collection. You will understand the questions to ask, the tools to utilize …