SEND: The Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) is based on the SDTM and guides users on the organization, structure, and format of standard nonclinical study tabulation datasets for exchange between organizations or to be submitted to a regulatory authority. The following videos introduce you to the SENDIG and the SDTM, which used together serve as a map that orients you on how your data fits into the standard.


A Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) is developed in reference to a specific SDTM model. However, the SDTM is cumulative – each new release builds on the previous model. Therefore, the models are backward compatible. The SENDIG is designed to support data typically found in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies, as well as respiratory and cardiovascular testing conducted during safety pharmacology studies.

Additional SENDIGs have been developed to support other study types. For example, SENDIG-DART v1.2 defines recommended standards for the submission of certain types of data collected in DART studies, in particular embryo-fetal development (EFD) studies and toxicity studies conducted on juvenile animals. SENDIG-AR v1.0 supports the submission of data from studies conducted under the Animal Rule. In addition to models and implementation guides, conformance rules have been developed, which help to ensure that generated data structures conform to the standards. These rules aim to identify all conformance rules and case logic from the SENDIG, classifying and codifying them in a form that supports quality processes and tool development.

Therapeutic Area User Guides

Controlled Terminology

Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. The following video introduces you to CDISC Controlled Terminology and how it is used with CDISC standards.


Regulatory Requirements

CDISC standards are required or recommended by several global regulatory agencies. Standardized data enables regulators to streamline the review process with a more consistent use of analysis tools to better view drug data and highlight areas of concern. The following video introduces you to regulatory requirements and the use of CDISC standards.

Team Guiding Principles

Standards in Development


For current versions of the standards, please visit the Standards Home Page.

Standard Sort descending Release Notes Projected Publication
ADaM Oncology Examples

Resolving Public Review Comments

ADaM v3.0

In Development

CT Relationships for SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1

Resolving Public Review Comments

SDTM v2.2

In Development


In Development


In Development


Data Exchange

Therapeutic Areas

For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.

Therapeutic Area Sort descending Release Notes Projected Publication
Duchenne Muscular Dystrophy Therapeutic Area User Guide v1.0

Version 1.0 of the Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD) was developed under the CFAST Program and the CDISC Standards Development Process. The TAUG-DMD describes the most common biomedical concepts relevant to Duchenne Muscular Dystrophy, and the necessary metadata to represent such data consistently with Terminology and  SDTM.

TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.

TA Specifications

TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG. These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2

The specifications comprise five worksheets in an Excel workbook:

  • Read Me – Information on how to read the other worksheets
  • Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
  • Known Issues – A list of modeling issues noted in the TAUG
  • Domains – Domains used and their status in different versions of the SDTMIG
  • Variables – Variables used and their status in different versions of the SDTM


SEND Courses