May 26, 2016 Meeting Notes
From PHUSE Wiki
Meeting minutes of Nonclinical_Script_Assessment_Project
May 26, 2016
|Present||First Name||Last Name||Affiliation|
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:
- We are aiming for new script development to be in R. We haven't established any standard output formats (PDF, HTML, etc)?
- What are the legal concerns for you to contribute meaningfully? - only BMS raised concerns. Pfizer is checking
- 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.