USDM to TDM Converter

This script converts Unified Study Data Model (USDM) JSON data into Study Data Tabulation Model (SDTM) Trial Design Model (TDM) datasets using JSONata expressions.

Prerequisites

• Node.js (version 14 or higher recommended)
• npm (comes with Node.js)

Installation

Install the required dependencies by running:

npm install jsonata
npm install json-2-csv

Usage

1. Place a USDM JSON file in the project directory and name it sdw-lzzt-usdm.json (or update the file path in usdm-to-tdm.js).

2. Run the script using Node.js:

node usdm2tdm.js -f <filepath to USDM JSON file>

1. The script will process the USDM JSON file and output the converted SDTM TDM dataset to the console and as CSV.

How It Works

• The script uses JSONata to extract and transform data from the USDM JSON file.
• It maps arms and elements to the SDTM TA domain structure.
• It maps criteria to the SDTM TI domain structure.
• It maps encounters to the SDTM TV domain structure.
• It maps elements to the SDTM TE domain structure.
• It maps characteristics and objectives to the SDTM TI domain structure.

Example Output

The output will look like this:

[
  {
    STUDYID: 'Study_CDISC PILOT - LZZT',
    DOMAIN: 'TA',
    ARMCD: 'StudyArm_1',
    ARM: 'Placebo',
    TAETORD: 1,
    ETCD: 'EL1',
    ELEMENT: 'Screening'
  },
  ...
]

Notes

I referred to the USDM v3 IG for this program. Website: Creation of SDTM Trial Design Domains

The file sdw-lzzt-usdm.json contains the study definition for the CDISC Pilot Study in the USDM v3.6 format. It was created using the Study Definitions Workbench from D4K. Website: Study Definitions Workbench

I am leaving space for post-processing to make these SDTM TDM datasets fully conformant. That part is outside the scope of this script.