Interorganizational SEND

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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 2014 and March 2015
  • Survey of industry SEND data from Small/Medium Service Providers: How prepared are they to supply data in SEND format?
  • Template to Facilitate Creating Pharmacokinetic SEND datasets


  • 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

At the March 2015 meeting:

  • It was determined that the remaining tasks envisioned for this group are a lower priority than the other pressing needs for collaboration in nonclinical computational sciences. As a result this project is complete.
  • The following items were considered as the next work for this team; so, as priorities adjust in the future, these may be worked on again:
  • Create a template for PP data and enhance the PP template 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.
  • 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.

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
  • George Kahlbaugh, Boehringer-Ingelheim
  • Laura Kaufman, Preclinical Data Systems
  • Rihab Kordane, Charles River Laboratory
  • Lou Ann Kramer, Eli Lilly
  • Wayne Kung, Genentech
  • Carolyn McGary, Bristol-Myers Squibb
  • Connie Marvel, Bristol-Myers Squibb
  • Shree Nath, PointCross
  • Louis Norton, Covance
  • Debra Oetzman, Covance
  • Daniel Potenta, Novartis
  • Kathleene Powers, Pfizer
  • Gerard Randoph, Roche
  • Maureen Rossi, Roche
  • Lynda Sands, GlaxoSmithKline
  • Paul Sidney, Charles River Laboratory
  • Jared Slain, MPI Research
  • Troy Smyrnios, Zoetis
  • Eric Sun, Sanofi
  • Kevin Trimm, Charles River Laboratory
  • Audrey Walker, Charles River Laboratory
  • Heather Williamson, PointCross
  • Peggy Zorn, INDS

Conference Calls and Minutes

Interorganizational SEND Minutes

Last revision by William.houser,03/14/2016