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Quick Start Guide

Get up and running with Trial Submission Studio in 5 minutes.

Overview

This guide walks you through the basic workflow:

  1. Import your source CSV data
  2. Map columns to SDTM variables
  3. Validate against CDISC standards
  4. Export to XPT format

Step 1: Launch the Application

After installing Trial Submission Studio, launch the application:

  • macOS: Open from Applications folder
  • Windows: Run trial-submission-studio.exe
  • Linux: Run ./trial-submission-studio

You’ll see the welcome screen where you can select your CDISC standard:

Welcome Screen

Step 2: Import Your Data

  1. Click Open Study Folder and select your data folder
  2. Trial Submission Studio will automatically:
    • Detect column types
    • Identify potential SDTM domains
    • Parse date formats

Tip

Your data should have column headers in the first row.

Step 3: Review Discovered Domains

Trial Submission Studio automatically discovers domains from your source data:

Study Overview

  1. Review the list of discovered domains (DM, AE, VS, etc.)
  2. Click on a domain to configure its mappings

Step 4: Map Columns

  1. Review the suggested column mappings
  2. For each source column, select the corresponding SDTM variable
  3. Use the fuzzy matching suggestions to speed up mapping

Column Mapping

The mapping interface shows:

  • Source Column: Your CSV column name
  • Target Variable: The SDTM variable
  • Match Score: Confidence of the suggested mapping (e.g., 93% match)

Step 5: Validate

  1. Switch to the Validation tab to check your data against CDISC rules
  2. Review any validation messages:
    • Errors: Must be fixed before export
    • Warnings: Should be reviewed
    • Info: Informational messages

Validation Results

Each validation issue includes the rule ID, a description, and suggestions on how to fix it.

Step 6: Export

  1. Click Go to Export or navigate to the Export screen
  2. Select which domains to export
  3. Choose your output format:
    • XPT (SAS Transport) (FDA standard)
    • Dataset-XML (CDISC data exchange)
  4. Click Export

Export Settings

Next Steps

Now that you’ve completed the basic workflow: