SS P03 08JUN2015

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Attendees

Mike

Hanming

Adie

Joy

Jeno

Dante

Peter

Dirk

John

Rebeka


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

OR


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


SETTLING ON THIS ???

  • 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 do 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?