SEND Leadership Team (SLT)
SEND Leadership Team Extended (SLTX)
a- CDISC TLC (Technical Leadership Committee) member
b- CDISC (Cross-team) Global Governance Group voting member
SEND Change Control Board(CCB)
SEND Subteams (leader)
SEND Controlled Terminology: Craig Zwickl
SEND Conformance Rules: Christy Kubin
SEND CCB: Jamie Gilliam
Dermal / Ocular Toxicity : Brian Argo
Genotoxicity (Gene Tox) : Michael Wasko
Reproductive Toxicology : Mary Jo Brucker
Micro and Microscopic: Daniel Potenta
Tumor Findings: Daniel Potenta
For a complete list of SEND initiatives (including all sub-teams and active workstreams, please see the SEND Home Wiki page at: SEND Home
Team Mission andScope
The CDISC SEND team develops standards that support both the regulatory submission of nonclinical data as well as the operational use and exchange of nonclinical data throughout the industry.
This team is responsible for overall development and maintenance of the production SEND IG (Implementation Guide) versions and their alignment with the SDTM.
SEND is one of the required standards for data submission to the FDA. Details on the requirements for the FDA are specified in the FDA’s Data Standards Catalog for IND, NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.
Production releases of the SEND standard:
The above deliverables are available to the public at: www.cdisc.org/SEND.
• Regulatory Authorities
The SEND Team maintains representatives on the CDISC cross-team governance in addition to a long-standing practice of working closely with the CDISC SDS, Controlled Terminology, and XML Technologies teams. With the release of SENDIG-DART v1.1, the SEND team is working closely with the CDISC SHARE effort.
The SEND team partners with the INHAND organization for pathology-related terminology (http://www.toxpath.org/inhand.asp). SEND also has a strong presence on the FDA/PhUSE Computational Sciences Symposium (CSS) (http://www.phuse.eu/css), including several leadership positions and significant overlap in membership with the Nonclinical Topics working group.
• Core Team membership is open to all interested parties with approximately seventy-five active members currently.
• Work-Streams are for all tasks that are not within the scope of the listed subteams and expected to have a clear start and end (ie, shorter term need). Work-streams are initiated by the CCB or SEND leadership. To develop new leaders on the SEND team, an experienced SLTX member will co-lead or mentor a newer leader for any new Work-Streams. All Subteams and Work-streams are governed by the SLTX and all work is reviewed by the Core Team.
Jennifer Feldmann, William Houser, Lou Ann Kramer, Louis Norton, Debra Oetzman, Troy Smyrnios, Audrey Walker, Fred Wood, Craig Zwickl
• SEND Core Team meets monthly on Wednesdays for 90 minutes. Active members meet face-to-face at the FDA two times each year.
• SEND subteams and CCB meet biweekly. Work-streams meet as needed.
• FDA/PhUSE CSS Working Group subteams meet regularly via teleconference.