02-02-2017 minutes

From PHUSE Wiki
Jump to: navigation, search
  1. Susan Lendal Antvorskov, from Data Standards Decisions, has joined the team. Welcome!
  2. Announcement that Laura Kaufman has resigned from co-leadership of the team because she will focus her energies as a PhUSE representative to the CDISC/C-Path Initiative regarding data standards for Animal Rule Studies. Thanks to Laura for all her contributions the past few years!
  3. We will not have a poster this year at CSS, because PhUSE received over the limit of posters for the meeting already.
  4. Goal for CSS is to deliver an update of the nSDRG guideline, taking into account comments received from FDA and others we have already addressed. Up to team to decide if feedback received from CRL will also be addressed by CSS (attached)
  5. Post meeting suggestions: At CSS, we should take a few moments to discuss our strategy, then align with Optimizing Use of Data Standards team for “Legacy Data Conversion Plan” – Their Wiki indicates a move to pulling it out of the SDRG again…. We can take a different position if warranted, but let’s get understanding between clin and nonclin.