Fill /doc folder with study documents

explore-eda / SilentNight-MT

A mock trial for In Home Assessment of Three Anti-Snoring Devices, a cross over study SRC-AI-SilentNight-10090 Version 3.0

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Fill /doc folder with study documents #7

Closed james-eda closed 7 months ago

james-eda commented 7 months ago

[x] Protocol
[x] SAP
[x] SDTM 3.4 + IG
[x] SDTM IG MD
[x] SDTM CT Workbook
[x] FDA Standards Catalog

james-eda commented 7 months ago

As other documents become available (tracker, aCRF, blankCRF, shells, annotated shells, etc). These documents serve as references to programmers. Some of the documents reference others (to develop the shell and specs, refer to protocol and SAP).

james-eda commented 7 months ago

@annayudovin here's where you will find the original study Protocol and SAP documents