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https://github.com/dominodatalab/cdisc01_study


https://github.com/dominodatalab/cdisc01_study

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README

        

# Protocol CDISC01 Study Repo

This repo contains the study specfic ADaM and TFL code for the CDISC01 protocol.

Each reporting effort (Interim, Ad Hoc, CSR etc.) is a branch within this repo.

# 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
│ ├───adam
├───adam_flows
├───tfl
│ └───tfl_flows
├───qc
│ ├───adam
│ │ compare_adam.sas
├───adam_flows
├───tfl
│ └───tfl_flows
├───utilities
│ init_datasets_re.py
│ import_metadata.sas
├───flows
└───share
└───macros
```

# Naming convention

The programs follow a typical clinical trial naming convention, where the ADaM programs are named using the dataset name (e.g. ADSL.sas, etc.) and the TFL programs have a `t_` prefix to indicate tables, etc.

# QC programming and reporting

The QC programming is all in SAS, and there is a `compare_adam.sas` program which uses SAS PROC COMPARE to create a summary report of all differences between the prod and qc datasets. This program also generates the `dominostats.json` files which Domino uses to display a dashboard in the jobs screen.

# Support

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