Test Submission Forum Group

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Welcome to the site for the "Test Submission Forum" project group.

This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on. We are part 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.

Working Group Overview

Identified Need/Challenge

Increase the number of test submissions submitted to the FDA and demystify this process. With the issuance of the Federal Register Notice, Providing Regulatory Submissions in Electronic Electronic Format-Standardized Study Data, Gudiance for Industry, there was the thought that those creating SEND datasets would start to participate in the test submission process implemented by the FDA. The lack of such test submission has lead to the creation of this team to look at ways to help identify the barriers to submitting test submissions and propose ways to overcome these barriers.

Project Scope

  • Industry Survey
  • Barrier identification
  • Identify incentives for companies to complete test submissions
  • What are the benefits to the FDA, companies that participate as well as the industry as a whole to increasing the number of test submissions (Better communication of potential value to all players)
  • How can we get the CRO perspective
  • Identify what companies/industry want to see in the feedback provided with the test submissions
  • Industry Webinar to review entire test submission process (initiated via PhUSE or FDA??)
  • Poster at CSS2017
  • White Paper
  • Test Submission FAQ wiki space

Vision

With the requirement effective date to provide regulatory submissions in electronic format for nonclinical data (SEND) fast approaching both the industry and the FDA are looking to ensure that the transition is smooth. To that end, the FDA had indicated that test submissions can be made to not only aid the industry in reviewing their processes but also aid the agency with their processes as well. To date there have not been many test submission made our team will dive into the barriers that there may be associated with completing test submission as well as investigate ways to demysitify the process.

To establish the barriers that are associated with this a brief survey will be sent out and from the results of this survy the team will determine what deliverables could developed to increase the number of test submissions, address the barriers and establish a forum where questions associated with the test submission process can be asked, discussed and answered. To do this the team will work with the SEND Implementation team to add space to the WIKI already in place.

Additional potential outputs from this team may also include a white paper, a poster at the PhUSE 2017 CSS as well as a webinar hosted by PhUSE or FDA surrounding the test submission process.

Development of a list of questions to submit to the FDA that surrounds the demystification of how they are going to use the data/information provided within these test submissions.

Plans

Milestones

March 2016 - April 2016

  • Poll SEND CDISC audience to determine what the barriers may be to their participation in submitting test submission to the agency

April 2016 - July 2016

  • Using the results of the survey determine what deliverables could developed to increase the number of test submissions, address the barriers and establish a forum where questions associated with the test submission process can be asked, discussed and answered.
  • Development of WIKI Test Submission FAQ section


July 2016 - August 2016

  • Depending on barriers may schedule Webinar around Test Submission
  • Development/creation of list of questions for the FDA to address regarding transparency around the information they receive within test submissions. “Demystify” what they do with the data received within the test.

August 2016 - March 2016

  • Create and publish a white paper
  • Poster for PhUSE CSS 2017

Tasks

  • Deterime meeting schedule
  • Create and circulate Poll to determine barriers
  • Review survey results and determine delieverables
  • Develop FAQ Wiki section for Test Submission Questions
  • Develop list of questions for FDA to demystify Test Submissions
  • Develop White Paper and Poster

Deliverables

Test Submission Forum

Responsible Task Status
Kathy Check with Regulatory group if a flow chart or information on the process exists Ongoing
Kathy, Dave, Debra Create poll and execute at SEND Core Team meeting Completed
Kathy Created second Poll and execute at SEND F2F using SEND CDISC distribution list Completed
Team Develop list of questions pertaining to the test submission process Ongoing
Team Develop wish list of what should be provided in the test submission feedback Ongoing
Dave Test Submission Process presentation Ongoing

Participation Needs

The team was established at the PhUSE CSS March 2016.

Call for participation!

What is the commitment?

  • Time (minimum of 1 hour every two weeks for team meetings, up to 3 hours / month)
  • Expected to contribute, not just be a spectator
  • Contribution of viewpoints and content
  • Wiki - creating/reviewing page content

If you would like to participate, please contact the co-leads for this group: Kathy Brown (Kathryn.Brown@sanofi.com) or David Epstein (David.Epstein@fda.hhs.gov)

Work Group Participants

Co-leads:

  • Kathryn Brown, sanofi
  • Dave Epstein, FDA

Participants:

  • Debra Oetzman, Instem
  • George Kahlbaugh, Boehringer-Ingelheim
  • Michael Wasko, PDS
  • Linda Sands, Independant Contractor
  • Christy Kubin, MPI
  • Jobst Loeffler, Bayer
  • Yuki Ando, PMDA
  • Jaga Virayah, Bayer
  • Brian Argo, MPI
  • Chris Eley, Pfizer
  • Keli Arnold, Pfizer

Conference Calls and Minutes

Our first telecon will be scheduled for the first week of April. Contact a co-lead for further details!

Test Submission Forum Minutes

Test Submission Forum Polls and Results

The link below will contain the results of the polls conducted by the Test Submission Forum Group.

Test Submission Forum Polls and Results


Last revision by Kathryn brown, 2016-05-26