SEND Leadership Team (SLT)
SEND Leadership Team Extended (SLTX)
a- CDISC TLC (Technical Leadership Committee) member
b- CDISC Cross-team Governance member
SEND Change Control Board(CCB)
SEND Sub-teams Subteams (leader)
SEND Controlled Terminology: Craig Zwickl
Reproductive Toxicology (and Pi: Mary Jo Brucker
SEND Conformance Rules: Christy Kubin
SEND CCB: Jamie Gilliam
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.
Jennifer Feldmann, Gitte Frausing, 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 sub-teams subteams and CCB meet bi-weeklybiweekly. Work-streams meet as needed.
• FDA/PhUSE CSS Working Group sub-teams subteams meet regularly via teleconference.