SEND

Introduction

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.


Versions

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 v1.1 supports submission of data from nonclinical Developmental and Reproductive Toxicology (DART) studies and 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.

Traceability

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

Foundational

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


Standard Sort descending Release Notes Projected Publication
ADaM OCCDS v1.1 and Conformance Rules

Resolving Public Comments.

Q4 2021
ADaM Oncology Examples

In Development.

2022
ADaM Traceability Examples

In Development.

Q4 2021
ADaMIG Medical Devices v1.0 and Conformance Rules

Resolving Public Comments.

Q4 2021
ADaMIG Non-compartmental Analysis v1.0 and Conformance Rules

Resolving Public Comments.

Q4 2021
ADaMIG v1.3 and Conformance Rules

Resolving Public Comments.

Q4 2021
CDASH v1.2

Preparing for Publication.

Q3 2021
CDASHIG v2.2

Preparing for Publication.

Q3 2021
Conformance Rules v2.0 for SDTM v2.0 and SDTMIG v3.4

Resolving Public Comments.

Q4 2021
Medical Devices Conformance Rules

In Development.

2022
SDTM v2.0

Resolving Public Comments.

Q4 2021
SDTMIG v3.4

Resolving Public Comments.

 

Q4 2021
SEND Conformance Rules v4.0

Public Review runs through 11 Jun..

Q4 2021

Data Exchange

For current versions of the Data Exchange standards, please visit the Data Exchange Page.


Standard Sort descending Release Notes Projected Publication
ODM v2.0

Preparing for Public Review.

2022

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
COVID-19 Therapeutic Area User Guide v1.0

Resolving Public Comments.*

*CDISC expedited our standards development process to release an Interim User Guide for COVID-19 in early April 2020. We are now developing a Therapeutic Area User Guide for COVID-19 following our standards development process outlined in COP-001.

Q2 2021
Crohn's Disease Therapeutic Area User Guide v1.0

Resolving Public Comments for Work Packages 1 and 2.

 

Q2 2021
Diabetes Type 1 Pediatrics and Devices: ADaM Examples Module

Resolving Public Comments.

Q2 2021
Diabetes Type 1 Therapeutic Area User Guide - Screening, Staging and Monitoring of Pre-clinical Type 1 Diabetes

Preparing for Public Review.

 
Q3 2021
Diabetes Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules

Preparing for Publication.

Q2 2021
Pancreatic Cancer Therapeutic Area User Guide v1.0

Resolving Public Comments.

Q3 2021
Rare Diseases Therapeutic Area User Guide

In Development.

Q1 2022
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Preparing for Public Review.

Q4 2021

Education

SEND Courses