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
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
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.
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.
Milestones/status of the pilot (Updated 27-Dec-2010)
|Finalization of Phase 1.||Completed|
|Initiation of Phase II||Completed 2 Jan 2008|
|Development of SEND implementation guide (IG) for pilot testing||Completed 14 Mar 2009|
|Release of SEND IG for public comment and pilot testing||Completed 21 Dec 2010|
|Release of SEND IG for production||Expected 2011|
|Receipt of SEND formatted-nonclinical data by CDER||Ongoing|
|Implementation of any needed changes to the data validation, viewing, and analysis tools.||Ongoing|
|Finalization of CDER Phase 2|
SEND at CVM
CVM SEND PILOT
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.
Milestones/status of the pilot (Updated 07-Apr-2011)
|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.
Questions regarding the Agency efforts for SEND and other CDISC standards should be directed to Lilliam Rosario.