You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 15 Next »

  1. SEND Home on the CDISC Website
  2. SEND Home on the CDISC Wiki (Access may be restricted to SEND Team Members)

SEND Leadership Team (SLT)

  • TBD (Incoming Leader) (a)
  • William Houser (Leader) (a)
  • Lou Ann Kramer (Past Leader) (a)
  • Chris Gemma (CDISC Liaison) (a)

SEND Leadership Team Extended (SLTX)

  • William Houser (Leader) (a)
  • Lou Ann Kramer (Past Leader) (a)
  • Chris Gemma (CDISC Liaison) (a)
  • Brian Argo
  • Kathryn Brown
  • Mary Jo Brucker
  • Sue DeHaven (PhUSE Liaison)
  • Marc Ellison
  • Gitte Frausing
  • Jamie Gilliam
  • Mattew Hayes
  • Christy Kubin
  • Louis Norton (b)
  • Debra Oetzman
  • Dan Potenta
  • Ben Sefing
  • Troy Smyrnios (b)
  • Erin Tibbs-Slone
  • Audrey Walker (b)
  • Michael Wasko
  • Fred Wood (b and Past Leader)
  • Craig Zwickl
  • FDA CBER Liaisons:
    • Virginia Hussong
    • Lisa Lin
    • Elaine Thompson
  • FDA CDER Liaisons
    • Crystal Allard
    • Dave Epstein
    • Kevin Snyder
    • Helena Sviglin
    • Kendra Worthy

a- CDISC TLC (Technical Leadership Committee) member

b- CDISC Cross-team Governance member

SEND Change Control Board (CCB)

  • Jamie Gilliam (Leader)
  • William Houser
  • Lou Ann Kramer
  • Louis Norton
  • Debra Oetzman
  • Audrey Walker
  • Fred Wood
  • FDA Liaison: Patricia Brundage

SEND Sub-teams (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 and Scope

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.  

Deliverables

Production releases of the SEND standard:

Standard & VersionSupplemental Materials

SENDIG v3.0, rel. 17June2011 (supports single- and repeat- dose general toxicology and carcinogenicity study data)

Confirmed Data Endpoints for SENDIG v3.0 Data Exchange
(CoDEx 1.0 for SEND v3.0), rel. 16Aug2017

SENDIG v3.1, rel. 07July2016 (supports single- and repeat- dose general toxicology and carcinogenicity study data)
SENDIG-DART v1.1, rel. 11Dec2017 (DART, Developmental and Reproductive Toxicology IG v1.1 supports Embryo Fetal Development Toxicity study data)
The above deliverables are available to the public at: www.cdisc.org/SEND. 



Stakeholders

• Regulatory Authorities
• Pharmaceutical Sponsors
• Nonclinical Research Scientists & Pathologists
• Contract Research Organizations
• Independent Consultants
• Information Technology Tool Developers
• Service Providers

Collaborations

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.

Operating Model

• Core Team membership is open to all interested parties with approximately seventy-five active members currently.
• Sub-teams are formed to manage long-term subject areas.
• Change Control Board (CCB) assesses and recommends action on changes requested regarding production SEND deliverables.
• SEND Leadership Team - Extended (SLTX) sets direction for the team, with representation from the CDISC TLC.
• Work-Streams are for all tasks that are not within the scope of the aforementioned sub-teams 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 Sub-teams and Work-streams are governed by the SLTX and all work is reviewed by the Core Team.
• Cross-team Integrators (or Business Integrators) are individuals who have demonstrated expertise with alignment across all domains and are often needed to review key concepts early in their development. Such individuals will often be needed is specific sessions at F2F weeks. This includes the following individuals:

Jennifer Feldmann, Gitte Frausing, William Houser, Lou Ann Kramer, Louis Norton, Debra Oetzman, Troy Smyrnios, Audrey Walker, Fred Wood, Craig Zwickl

Meetings

• 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 and CCB meet bi-weekly. Work-streams meet as needed.
• FDA/PhUSE CSS Working Group sub-teams meet regularly via teleconference.


  • No labels