May 12, 2016 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

May 12, 2016

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Yes Kevin Cahill EPL
Yes Bill Varady Boehringer-Ingelheim
Bob Dorsam FDA
Bob Friedman Xybion
Chris Eley Pfizer
Fred Mura PDS
Yes Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb

Action Items from previous meeting:

Notes from this meeting:

  1. Discuss questions regarding the current GitHub conventions used by the clinical team. -no questions
  2. Are the status definitions useful and appropriate for us?
  3. Is it useful to prioritize script ideas? perhaps collecting names of who is willing to write, test, and use them?
    1. maybe later after we have some experience working together.
  4. Do we want to create a process to consult with vendors before creating a script to ensure we don't discourage them from creating more useful tools?
    1. limiting our scope?
    2. talk to the vendors to understand their concerns? Bill H will ask them to join a future call.
    3. they can sell what we create.
  5. What should we aim for scripting languages (R) and output formats (PDF, HTML, etc)?
    1. let's consider standardization after we have more experiments.
  6. How do we appropriately use the data folder to facilitate script creation and testing?
  7. What are the legal concerns for you to contribute meaningfully? - only a concern for one company.

Script Ideas:

  • We will need scripts to help with getting data in, relationships established, and ready to be processed and analyzed
  • SEND to tumor.xpt converter
  • Tool to assist in obscuring Test Article Identifiers, Study Numbers, and other sensitive information from SEND datasets