WG6 Nonclinical - Standardization Roadmap

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Roadmap for nonclinical data informatics accessibility

Welcome to the Wiki for the Roadmap for nonclinical data informatics accessibility Project, part of the of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.

Overview & Scope

Need/Challenge Need ID 0030. Currently, the SEND standard allows for the submission of general tox and carc studies in electronic standardized format. However, there are additional study types that are generally received that have not been standardized. There is a need to develop a strategy on how to prioritize, maximize, and transform standardization efforts. This plan should take into account resources, complexity, timeline and new approaches and technologies. Data gaps identified: Study data - Safety Pharm, Repro, Genetox, hERG, Animal Rule/MCM, Receptor Screen, Device combination; Drug metadata - Lot and Imp linked to study data, class, structure; Study Metadata- Protocol related info + deviation, regulatory interpretation, sponsor interpretation, regulatory information.

Vision

Availability of useful electronic meta- and study data to enable more effective and efficient reviews of nonclinical data by both industry and regulatory reviewers. Availability to further investigate class effects and address regulatory science questions.


Plans

Identified Projects/Pilots/Activities

  1. Communication of the CDISC SEND team roadmap/goals
  2. Get priorities and then Limit the scope of the nonclinical roadmap for the immediate future
  3. A directory of knowledge on current standardization initiatives
  4. Use-cases from industry & regulators on how to look at e data (approaches and standard panels)
  5. Define issues relating to GLP adherence for e-data

Milestones

[To Team: dates needed]

  1. Pass it on to the CDISC SEND team
  2. Set up the workgroup forum on the WIKI
  3. Establish regulatory use case using CDER pilot data

Tasks

Planned

  1. Define subgroups for each area

Accomplished


Deliverables

March 2012 - March 2013

  • Small and graphic, and e-paper (so it can be flexible – living document)
  • Get list of priorities then define scope? 3m
  • Directory of standardization initiatives. 3m


Participation needs

The following types of stakeholders are encouraged to participate:

  • Pharma
  • CROs
  • Regulatory
  • Vendors


Communications

  • Teleconference are held []
    • [T-con details]
  • Quarterly updates to overall WG.
  • Contact [x] with any questions

Work Group Participants

Gitte Frausing, Novo Nordisk (co-lead)

Bob Dorsam, FDA (co-lead)

Alain Nanzer, Roche

Deborah Sholtes, FDA

Lou Ann Kramer, Eli Lilly

Jerker Ringstrom, SixSteps AB

Geoff Mann, SAS Institute

John Anderson, Novo Nordisk

Natalia Smeljanski, Merck

Lynda Sands, GlaxoSmithKline




Conference Calls and Minutes

WG6 DDMONYYY



Last revision by TJKropp,03/23/2012