Interorganizational SEND

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Revision as of 10:47, 22 July 2014 by William.houser (talk | contribs) (Project Team)
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Interorganizational SEND Project

Welcome to the Wiki for our project to identify challenges and propose solutions to help Sponsors and CROs, to work efficiently together, in a world where nonclinical data, possibly derived from different organizations, will be required to be aggregated in SEND format, for submission to the FDA.

Need/Challenge

The responsibilities for creating the SEND files for a study is often shared across organizations. Clarity is needed on how these responsiblities can be effectively managed.

Accomplished

  • Between March 2013 and March 2014
  • Points to consider list when preparing to create SEND datasets for studies that involve multiple organizations:


  • Between March 2012 and March 2013
  • We developed a framework to classify and prioritize scenarios in which data from multiple orginzations needs to be aggregated.
  • We selected 3 scenarios and for each developed workfows "on-paper" to create and submit SEND datasets.
  • While considering these scenarios we identified several questions that needed to be answered and collaberatively developed answers. These have been published on the PhUSE SEND User's Group wiki: Handling of SEND in Study Documentation
  • We started preparing a Scenarios White Paper
  • We published a poster at the 2013 FDA/PhUSE Computational Science Symposium, which is available as slides File:I-SEND Poster 2013 as slides.pdf

Plans

By March 2015:

  • Create a template for PC/PP data to provide organizations without SEND capabilities a way to provide TK data in a format that can more easily be integrated into a set of SEND datasets for a study.
  • Create the template
  • Pilot its use
  • Create a "points to consider" list
  • Adjust the template as needed
  • Publish the results on the PhUSE SEND Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium.
  • Evaluate the applicability of other CDISC standards CDASH, ADaM, ODM for non-clinical studies and publish the results on the PhUSE SEND Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium.

Participation Needs

In 2014 as we will continue this work, we will need participation from individuals with the following areas of expertise with an interest and ideally gaining some experience exchanging data or reports with other organizations to contribute to this effort:

  • Scientists
  • IT Specilists
  • SEND implementers
  • GLP QA auditors

What is the commitment?

  • Time - will vary widely (minimum of 1 hour every two to four weeks for team meetings, up to 4-8 hours / month)
  • Expected to contribute, not just be a spectator

If you would like to participate, please contact the co-leads for this group:

  • Debra Oetzman (debra.oetzman@covance.com)
  • William Houser (william.houser@bms.com)

Communications

1 telecon every 2 weeks at the same time. One such meeting is 2pm Eastern Jun 23, 2014.

Project Team

  • Pranav Agnihotri, PointCross
  • Kenjie Amemiya, Genentech
  • Brian Argo, MPI Research
  • Rich, Buchanan, Preclinical Data Systems
  • Kathryn Brown, Sanofi
  • Susan DeHaven, Sanofi
  • Steven Denham, MPI Research
  • Jennifer Feldmann, Instem
  • Jeff Foy, Celgene
  • Geoff Ganem, Genentech
  • Nancy Gongliewski, Novartis
  • Elizabeth Gram, Zoetis
  • William Houser, Bristol-Myers Squibb
  • Laura Kaufman, Preclinical Data Systems
  • Lou Ann Kramer, Eli Lilly
  • Wayne Kung, Genentech
  • Carolyn McGary, Bristol-Myers Squibb
  • Maureen Rossi, Roche
  • Connie Marvel, Bristol-Myers Squibb
  • Shree Nath, PointCross
  • Louis Norton, Covance
  • Debra Oetzman, Covance
  • Daniel Potenta, Novartis
  • Kathleene Powers, Pfizer
  • Gerard Randoph, Roche
  • Lynda Sands, GlaxoSmithKline
  • Paul Sidney, Charles River Laboratory
  • Jared Slain, MPI Research
  • Troy Smyrnios, Zoetis
  • Eric Sun, Sanofi
  • Audrey Walker, Charles River Laboratory
  • Heather Williamson, PointCross
  • Peggy Zorn, INDS

Conference Calls and Minutes

Interorganizational SEND Minutes

Last revision by William.houser,07/22/2014