- SEND Home on the CDISC Website
- SEND Home on the CDISC Wiki (Access may be restricted to SEND Team Members)
- 2015 CDISC Technical Plan
SEND Leadership Team (SLT)
a- CDISC TLC (Technical Leadership Committee) member b- CDISC Cross-team Governance member |
SEND Change Control Board (CCB)
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SEND Sub-teams SEND Controlled Terminology: Craig Zwickl Reproductive Toxicology (and Pilot): Mary Joe Brucker Safety Pharmacology: Jennifer Feldmann SEND IG: Brandy Harter FDA CDER Pilot Liaison: Lauren Murphree- Mihalcik |
Team Mission and Scope The SEND team develops standards that support both the regulatory submission of nonclinical data as well as the operational use of nonclinical data throughout the industry. This team is responsible for overall development and maintenance of the production SEND IG (Implementation Guide) and it’s alignment with SDTM. SEND IG v3.0 was released in 2011 (available at: www.cdisc.org/SEND). This version supports single-dose and repeat- dose general toxicology and carcinogenicity study data. SEND datasets are accepted now and will be required in future FDA Submissions per the following guidances: •“Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act” - parent guidance •“Providing Regulatory Submissions in Electronic Format – Standardized Study Data” •“Study Data Technical Conformance Guide” |
SEND Team Structure and Operations • Core Team membership is open to all interested parties with over eighty-five members currently. • Sub-teams formed to manage long-term subject areas. • Change Control Board (CCB) assesses and recommends action on changes requested regarding the production SEND IG. • SEND Leadership Team (SLT) sets direction for the team, with representation from the CDISC TLC. • Work-Streams initiated by the SLT and CCB 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). |
SEND Work-Stream Leaders and Cross-team Integrators When a task, issue or group of issues is identified for a Work-Stream, by the SEND CCB, an experienced SEND member leads the Work-Stream and reports back to the CCB and Core Team until the topics reach closure. Jennifer Feldmann, Gitte Frausing, Brandy Harter, William Houser, Lou Ann Kramer, Louis Norton, Debra Oetzman, Troy Smyrnios, Audrey Walker, Fred Wood, Peggy Zorn |
Collaborations and Meetings The SEND Team maintains two representatives on the CDISC cross-team governance in addition to a long-standing practice of working closely with the CDISC SDS team and CDISC Controlled Terminology. This year, SEND has joined 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 working group: “Nonclinical Roadmap and Impacts on Implementation”.
• SEND Core Team meets bi-weekly on Wednesdays for 90 minutes. Active members meet face-to-face at the FDA two times each year. • SEND sub-teams meet bi-weekly on alternating weeks from Core Work-streams and CCB meet as needed. • FDA/PhUSE CSS Working Group sub-teams meet regularly via teleconference. |
2015 Objectives • SEND IG v3.1 – approximately 200 comments addressed • SEND IG v3.1 production • Repro IG v1.0 provisional standard final • New study data modeling initiated (e.g. Ocular, Micronucleus) • Controlled terminology to maintain the production IG and support development efforts for Safety Pharmacology: modeling for CNS study types • Develop appropriate versioning (aligned with CDISC and FDA procedures) • Improve Effectiveness, Ease of Use and Transparency of Communications, including adopting CDISC collaboration tools • Improve change control by integrating existing SEND Change Control with CDISC comment tracking, archiving, and JIRA |
Stakeholders/Constituency • Regulatory Authorities • Standards Development Organizations • Pharmaceutical Sponsors • Nonclinical Research Scientists & Pathologists • Contract Research Organizations & Consultants • Information Technology Tool Developers & Service Providers |