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SCE_SDTM_TEMPLATE

This repo and corresponding Domino Project contains the folder structure to template a study wide SDTM project.

This repo project is copied by Data Management to instantiate a new study specfic SDTM GitHub repo and Domino Project.

Directory structure

The programming is created in a typical clinical trial folder structure, where the production (prod) and qc programs have independent directory trees.

Reporting effort level standard code (e.g. SAS macros) should be stored in the share/macros folder.

The global domino.sas autoexec progam is also included in the repository to appropriately set up the SAS environment.

repo
│   domino.sas
├───prod
│   └───sdtm
├───qc
│   └───sdtm
└───utilities
        init_datasets.py
└───share
    └───macros

Setup

  1. Create a new project, named CDISC01_SDTM, from copying this project. This will create a new project and a new study specfic GitHub repo.
  2. Run utilities/init_datasets_sdtm.py as a job to create the appropriate SDTM Domino Datasets (SDTMBLIND, SDTMUNBLIND and METADATA).

Naming convention

The programs follow a typical clinical trial naming convention, where the SDTM programs are named after the datasets they are producing (e.g. DM.sas, AE.sas, etc...)

Support

Programming was created by Veramed Ltd. on behalf of Domino Data Lab, Inc.