- SEND Home on the CDISC Website
- SEND Home on the CDISC Wiki (Access may be restricted to SEND Team Members)
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 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 |
Stakeholders • Regulatory Authorities |
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 Guides (Implementation GuideIGs) 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. | |
SEND Deliverables Production releases of the SEND standard: | |
| Standard & Version | Supplemental 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 | SENDIG v3.1, rel. 07July2016 (supports single- and repeat- dose general toxicology and carcinogenicity study data as well as respiratory and cardiovascular safety pharmacology data) | SENDIG-DART v1.1, rel. 11Dec2017 (DART, Developmental and Reproductive Toxicology IG v1.1 supports Embryo Fetal Development Toxicity study data) |
SEND Subteams (leader) SEND Controlled Terminology: Erin Tibbs-Slone SEND Conformance Rules: Christy Kubin SEND CCB: Jamie Gilliam Dermal / Ocular Toxicity : Brian Argo Exposure : Wenxian Wang Genotoxicity (Gene Tox) : Michael Wasko Immunogenicity Specimen Assessments: Robert Friedman, Alex Kistner, Anthony Fata Pharmacokinetic Concentrations & Parameters: Stephanie Berry Safety Pharmacology: Christy Kubin Trial Domain enhancements: Anthony Fata, Brandy Harter Developmental & Reproductive Toxicology : Marc Ellison Macro and Microscopic: Rachel Harper, Matt Hayes Tumor Combinations: Charlotte Keenan For more details on SEND initiatives, please see the SEND Home Wiki page at: SEND Home 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 many 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.initiatives. SEND also maintains 2 - 3 seats on the CDISC governance. 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 Full Team membership is open to all interested parties with approximately seventy-five comprises all SEND members, with well over one hundred active members currently. • Work-Streams are , when needed, are for all tasks that are not within the scope of the aforementioned 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. • Leadership Mentors - 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. 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. They typically have an understanding of the CDISC and SEND strategy and approaches to certain concepts and designs and will look at impact beyond a domain, across domains and even across multiple "child" IGs. Such individuals will often be needed in specific sessions at F2F weeks. This includes the following individuals: Jennifer Feldmann, Gitte Frausing, William Houser, Lou Ann Kramer, Christy Kubin, Louis Norton, Debra Oetzman, Troy SmyrniosBen Sefing, Audrey Walker, Mike Wasko, 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 Leadership Team Extended (SLTX) - meets monthly on Wednesdays for 90 minutes (alternating bi-weekly with Core Team).
• SEND subteams and CCB meet biweekly.
• Work-streams meet as needed.
• FDA/PhUSE CSS Working Group subteams meet regularly via teleconference.