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.