May 26, 2016 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

May 26, 2016

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

Action Items from previous meeting:

  • Fred Mura will see if he can share their sample SEND data.
    • Fred will be able to share.
  • Bill Houser will ask Instem if they can supply their SEND data.
    • no answer yet from Instem
  • Bill Houser will add a couple SAS scripts.
    • delayed due to legal concerns
  • Bill Houser will contact SEND related vendors asking for their concerns and to join us in a future meeting
    • They have been invited to our June 23 meeting.
  • Kevin Snyder is working on getting some scripts for working with PK files
  • Bill Houser will add instruction for new members to get an account.
  • Fred Mura will check academic contacts to see if there is interest in R or SAS programing.
  • Bill Houser will check institutions in southern Indiana
  • Elaine will check looking for Toxicology areas and contact at George Washington University

Notes from this meeting:

  1. We are aiming for new script development to be in R. We haven't established any standard output formats (PDF, HTML, etc)?
  2. What are the legal concerns for you to contribute meaningfully? - only BMS raised concerns. Pfizer is checking

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
  • Script to convert *.xpt file to Excel and another one to convert it back. (concern: SAS v5 xpt doesn't represent numbers in IEEE format. This may lead to precision issues when converting values back and forth between xpt and other formats.)
  • A tools that reports on data quality and completeness (not to conflict with validators) - might be useful for reporting to the FDA how we QC'd the dataset before submission.