For Industry

Standard for Exchange of Non-Clinical Data

The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model for non-clinical studies. This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND Team for non-clinical data collected from animal toxicology studies.

SEND Implementation Guide

The production version of the SEND Implementation Guide (IG) Version 3.0 (SENDIG 3.0) is NOW available at http://www.cdisc.org/send.
It is expected that this implementation guide will evolve, particularly to accommodate additions for reproductive toxicology, safety pharmacology, and veterinary studies.
In addition, SEND and STDM terminology that will be used by SEND v3.0 is available at http://www.cdisc.org/send.

SEND at CDER

REGULATORY SUBMISSION

CDER currently supports SEND IG v3.0 for regulatory submissions of tabulated toxicology data in electronic format provided that a complete study report is also submitted. Sponsors should see the continue to consult the Study Data Standards for Submission to CDER website for additional information including Study Data Specifications

CDER SEND PILOTS

Phase I

Work on this standard began in July 2002—subsequently, an FDA pilot project was initiated in July 2003 in conjunction with a Cooperative Research and Development Agreement (CRADA) to develop software to validate, view, analyze SEND datasets. Feedback from this pilot led to development of the SEND v2.3 implementation guide (IG), which covers carcinogenicity, single-dose and repeat-dose general toxicology studies.

Phase II

In October 2007, FDA announced a second SEND pilot to continue the evaluation of SEND, this time in a regulatory setting for products regulated by the Center for Drug Evaluation and Research (CDER) (Electronic Nonclinical Study Data Submission; Notice of Pilot Project)

The Phase II pilot is being extended for development of the SEND for submission of safety pharmacology and reproductive toxicity studies.

Pilot Participation: FDA is not currently enrolling pilot participants. Eight participants requested participation in the CDER pilot. These participants are currently engaged in a re-baseline effort to update the SEND implementation guide to ensure harmonization of the CDISC study data standards across both clinical and nonclinical data where feasible.

Instructions on how to submit nonclinical data as part of the pilot program

Milestones/status of the pilot (Updated 27-Dec-2010)

Milestones	Status	Comments
Finalization of Phase 1.	Completed	Phase I asked volunteers from industry to submit sample nonclinical datasets in the SEND format outside of a regulatory setting (68 FR 3885; January 27, 2003). Phase I pilot resulted in development of a SEND Implementation Guide (Version 2.3; November 2005). Also, resulted in the development of specialized software tools for validating, displaying, and analyzing SEND-formatted nonclinical data (ToxVision).
Initiation of Phase II	Completed 2 Jan 2008	Phase II continues the evaluation of SEND in a regulatory setting for products regulated by CDER (Electronic Nonclinical Study Data Submission; Notice of Pilot Project) 8 parties requested participation in the pilot
Development of SEND implementation guide (IG) for pilot testing	Completed 14 Mar 2009	Release of SENDIG v3.0 Draft A. This version is not backwards compatible to v2.3).
Release of SEND IG for public comment and pilot testing	Completed 21 Dec 2010	SENDIG v3.0 released for public comment.
Release of SEND IG for production	Expected 2011	Production IG for creation of SEND formatted datasets for general toxicology and carcinogenicity studies.
Receipt of SEND formatted-nonclinical data by CDER	Ongoing	Phase 2 enables FDA to evaluate animal toxicity data submitted in SEND format in a regulatory setting by comparing SEND formatted data provided electronically as SAS transport file (XPT version 5) datasets with data provided in the "archival" PDF format.
Implementation of any needed changes to the data validation, viewing, and analysis tools.	Ongoing	This step will provide data validation and analysis/visualization tools able to validate SEND datasets according to the current SEND standard. Will enable a reviewer to visualize and evaluate data from animal toxicity studies submitted in the SEND format.
Finalization of CDER Phase 2		FDA anticipates that a successful pilot will allow CDER to routinely accept specific types of nonclinical study data provided electronically based on the SEND format.

SEND at CVM

CVM SEND PILOT

Phase I

An FDA pilot project was initiated in 2009 (http://www.gpo.gov/fdsys/pkg/FR-2009-12-10/pdf/E9-29419.pdf ) with publication of Federal Register notice announcing the Center for Veterinary Medicine (CVM)’s intent to evaluate nonclinical data submission in SEND format. To evaluate the adequacy of the current SEND format for data review, CVM identified multiple types of both margin of safety and nonclinical toxicology studies, and we are currently ready to accept data files.

Pilot Participation: Seven companies volunteered to participate in the CVM pilot. These participants are currently engaged in preparing and submitting data and reports for evaluation. FDA is not currently enrolling new pilot participants.

Instructions on how to submit data and reports as part of the pilot program

Milestones/status of the pilot (Updated 07-Apr-2011)

Milestones	Status	Comments
CVM publishes FR notice (74 FR 65540) asking for volunteers from industry to submit sample nonclinical datasets in the SEND format	Completed	7 parties requested participation in the pilot
CVM convenes pilot participants to refine project plan and collect study submission plans	Completed	Q2 2010
Receipt of SEND formatted-nonclinical data to CVM	Ongoing	Expected 2011
Update of SEND implementation guide to include CVM’s requirements	Ongoing	Expected 2012
Implementation of any needed changes to the data validation, viewing, and analysis tools.	Ongoing	Expected 2012
Finalization of CVM Phase 1		Planned March 2013

SEND at CBER, CDRH, CFSAN

Currently, the FDA is determining the nonclinical data standards requirements for the Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Food Safety and Applied Nutrition.

SEND at NCTR

National Center for Toxicological Research (NCTR) in collaboration with CDER and CVM staff is supporting the SEND pilots by hosting SEND data and making them available to reviewers. The goal of NCTR’s participation is to identify key bottlenecks and limitations of current e-submission strategies and identify best practices to facilitate data flow at each stage of the data submission pipeline.

Contact Information

Questions regarding the Agency efforts for SEND and other CDISC standards should be directed to Lilliam Rosario.