Standard for Exchange of Nonclinical Data
SEND IG 3.0 Draft A
We are pleased to announce the release of the SEND Implementation Guide (SENDIG) v3.0 Draft A which includes SEND Controlled Terminology for v3.0 Draft A.
SENDIG 3.0 Draft A is the first new release of the SEND data standard since 2005 and is the work product of well over 40 people working collaboratively for many months. It represents a significant realignment to current standards for CDISC data models (i.e. Study Data Tabulation Model).
The SENDIG 3.0 Draft A has been prepared specifically for the purposes of the Phase II FDA Pilot of nonclinical studies for testing purposes and should not be considered the official CDISC production version. This implementation guide will evolve throughout the course of the FDA pilot, and subsequent iterations of the document will be released prior to an official CDISC production version. SEND 3.0 Draft A is not backward compatible to SEND Version 2.3.
Companies participating in the pilot should refer to the Federal Register notice from the FDA website for more information regarding the pilot:
http://www.fda.gov/ForIndustry/DataStandards/CDISCDataStandards/ucm155320.htm
Implementation Guide for Animal Toxicology Studies Version 2.3
SEND V2.3
Version 2.3 of the SEND model has been released by the CDISC SEND Team. The Standard for Exchange of Nonclinical Data (SEND) Models have been prepared by the SEND Team to guide the organization, structure, and format for non-clinical data submitted to the FDA. The focus of the SEND Team is on data collected from animal Toxicology studies. SEND v2.3 covers single-dose, repeat-dose and carcinogenicity studies. Please also refer to the Study Data Tabulation Model (SDTM) which represents the underlying conceptual model behind the SEND standard. Comments on any of these documents can be submitted through CDISC's public Discussion Forum at any time.
The FDA is not currently prepared to accept SEND datasets. Once they are, there will be a series of validations performed to ensure the datasets comply. The FDA has been working with PharmQuest PointCross under a CRADA to develop the validation checks as part of the ToxVision tool.
A Federal Register notice announcing a regulatory pilot project for the submission of SEND datasets is expected within the next month. Participants will be submitting SEND data along with the traditional PDF files as part of active INDs. The specifications for the pilot datasets will be based upon SEND v2.3, with some modifications for greater consistency with the SDTM v.1.1 and SDTM Implementation Guide (for Human Clinical Trials) v 3.1.1. Feedback from the pilot will also be taken into account in developing the SEND version that will ultimately be the basis for guidance and/or regulation. Because of pilot dependencies, it is difficult to predict when a final implementation-ready version of SEND will be published, but the earliest is estimated to be mid-2008.
