- 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 Governance member |
SEND Change Control Board(CCB)
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SEND Sub-teams (leader) SEND Controlled Terminology: Craig Zwickl Reproductive Toxicology (and Pilot)Pi: Mary Jo Brucker SEND Conformation Conformance Rules: Christy Kubin SEND IG/ CCB: Jamie Gilliam FDA CDER Pilot Liaisons: Elaine Thompson, Helena Sviglin, and David Epstein PhUSE Liaison: Susan DeHavenFor 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 FDA.Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data. Deliverables Production releases of the SEND standard:
The above deliverables are available to the public at: www.cdisc.org/SEND. | ||||||||
Stakeholders
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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 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 ModelSEND TeamStructureand Operations • Core Team membership is open to all interested parties with over eightyapproximately seventy-five active members currently. production SEND IGdeliverables. SLTX)sets direction for the team, with representation from the CDISC TLC. 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). SEND Work-Stream Leadersand Cross-teamIntegratorsWhen a task, issue or group of issues is identified for a Work-Stream, by the SEND CCB, an experienced SEND member leads or mentors a newer leader for the Work-Stream and reports back to the CCB and Core Team until the topics reach closure.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. Jennifer Feldmann, Gitte Frausing, Brandy Harter,William Houser, Lou Ann Kramer, Louis Norton, Debra Oetzman, Troy Smyrnios, Audrey Walker, Fred Wood, Peggy ZornCraig Zwickl Collaborations and |
Meetings
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 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.• 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
Stakeholders/Constituency
• Nonclinical Research Scientists & Pathologists
• Service Providers
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 is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.
SEND is one of the required standards for data submission to FDA.
Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.