SS P03 08JUN2015

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Mike and Chris did not send an agenda prior to the meeting.

We looked at the content Gustav and Rebeka sent (pasted below, looks good when editing, not wiki-formatted-friendly).

Jeno to talk with Chris B on some of those "data" folder ideas.

  • Topic
    • AE
      • Contributed
        • Qualified Program 1
        • Qualified Program 2
      • White Paper
        • Qualified Program 1
        • Qualified Program 2


  • Topic
    • AE
      • Qualified Program 1 (contributed 1)
      • Qualified Program 2 (contributed 2)
      • Qualified Program 3 (white paper 1)
      • Qualified Program 4 (white paper 2)


  • Topic Folder
    • AE Folder
      • Qualified Program 1 File
      • Qualified Program 1 YML File
      • Qualified Program 1 Support Folder (if needed)
      • Qualified Program 2 File
      • Qualified Program 3 File
      • Qualified Program 4 File
      • Example_Outputs_from_SAS Folder
        • Qualified Program 1 example SAS output File
      • Example_Outputs_from_R Folder
    • Utilility Program Folder
  • Data Folder
    • SDTM(tabulated) Folder
      • Fake Statin Data Folder
        • AE Test Dataset file
        • DM Test Dataset file
        • LB Test Dataset file
    • ADaM(derived/analysis) Folder
      • Fake Statin Data Folder
        • AE Test Dataset file
        • DM Test Dataset file
        • LB Test Dataset file

But ... if we metadata good, then the index page will handle a lot of this

Question: For FDA-delivered content, how best to put it?

Our goals:

1. Reach consensus on new folder structure 2. Move current contents to the new folder structure 3. Review YML contents 4. Re-run script index building (strip columns)

From Gustav/Rebeka (May 26 2015):

• Whitepaper topic o Adverse events (whitepaper subtopic)  Contributed (These have not gone through the qualification process. The address the same topic as the whitepapers, but the output is not used directly in the whitepapers.) • Severity (put the programs at this folder level) o Output o Templates (We’re not sure what these are used for. We put them in with their corresponding program folder) • Toxicity o Output o Templates • MedDRA o Output o Templates  Documentation (contains YML, user guides or any other documentation for the scripts)  Qualified Programs (SAS and R programs. These have gone through the qualification process for whitepapers. We could call this qualified programs since most people are used to the term program instead of scripts) • Output (Give an example program output. We can see the display in the whitepaper, but having a snapshot of the actual programs’ outputs are helpful)  Whitepaper (Have copy of actual white papers or a link) o Demographics (whitepaper subtopic)  There are 2 folders for the contributed (DM and Demographics). Are there differences between them?  This would follow a similar structure as the adverse events.

For Contributed output, how much will our group do to the scripts? Will we actually have output? Will they go through the qualification process?