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Find original SAP and other documents from CDISC Pilot and collect R-based Pilots documents #11

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bms63 opened this issue Jan 25, 2025 · 2 comments
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documentation Improvements or additions to documentation provenance Historical record of data sources

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@bms63
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bms63 commented Jan 25, 2025

Background

This data has existed since ~2008, which laid the groundwork for CDISC standards becoming the accepted standard for Drug Submissions.

There are lots of documents surrounding the CDISC Pilot and be good to compile them all into a original-documents folder available to our developers and to those who come after us.

At the minimum we should find the SAP, but other relevant documents will be helpful.

Definition of Done

  • create original-documents in repo
  • create pilot-documents in repo
  • Find original SAP and move to new folder
  • Find additional/other original documentation on the __CDISC Pilot__data (old presentations, repos, etc)
  • Collect documentation on R-submissions Pilots and store in the pilot-documents (FDA Response letters, ADRGs, etc)
  • (bonus) Create a Readme file in the folder that links to past resources to increase accessibility. (old presentations, repos, etc)
@robertdevine
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@bms and @parmsam-pfizer, yes, there are a few other relevant documents which we will add also.

@robertdevine robertdevine added the documentation Improvements or additions to documentation label Jan 25, 2025
@robertdevine
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Going to use GPG keys for this issue so we have verified provenance and links (both source and target).

@robertdevine robertdevine added the provenance Historical record of data sources label Jan 25, 2025
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Labels
documentation Improvements or additions to documentation provenance Historical record of data sources
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Status: Todo
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