Architecture Overview

Trial Submission Studio is built as a modular Rust workspace with 6 specialized crates.

Design Philosophy

Core Principles

1. Separation of Concerns - Each crate has a single responsibility
2. Deterministic Output - Reproducible results for regulatory compliance
3. Offline Operation - All standards embedded, no network dependencies
4. Type Safety - Rust’s type system prevents data errors

Key Design Decisions

• Pure Functions - Mapping and validation logic is side-effect free
• Embedded Standards - CDISC data bundled in binary
• No External APIs - Works without internet connection
• Auditable - Clear data lineage and transformations

Workspace Structure

trial-submission-studio/
├── Cargo.toml              # Workspace configuration
├── crates/
│   ├── tss-gui/            # Desktop application (Iced 0.14.0)
│   ├── tss-submit/         # Mapping, normalization, validation, export
│   ├── tss-ingest/         # CSV loading
│   ├── tss-standards/      # CDISC standards loader
│   ├── tss-updater/        # App update mechanism
│   └── tss-updater-helper/ # macOS bundle swap helper
├── standards/              # Embedded CDISC data
├── mockdata/               # Test datasets
└── docs/                   # This documentation

Crate Dependency Graph

flowchart TD
    subgraph Application
        GUI[tss-gui<br/>Iced 0.14.0]
    end

    subgraph "Core Pipeline"
        SUBMIT[tss-submit]
        subgraph modules[tss-submit modules]
            MAP[map/]
            NORM[normalize/]
            VAL[validate/]
            EXP[export/]
        end
    end

    subgraph Support
        INGEST[tss-ingest]
        STANDARDS[tss-standards]
    end

    subgraph Update
        UPDATER[tss-updater]
        HELPER[tss-updater-helper]
    end

    subgraph External
        XPT[xportrs<br/>crates.io]
    end

    GUI --> SUBMIT
    GUI --> INGEST
    GUI --> STANDARDS
    GUI --> UPDATER
    SUBMIT --> STANDARDS
    SUBMIT --> XPT
    UPDATER -.-> HELPER
    INGEST --> STANDARDS

    style GUI fill:#4a90d9,color:#fff
    style SUBMIT fill:#50c878,color:#fff
    style STANDARDS fill:#f5a623,color:#fff
    style XPT fill:#9b59b6,color:#fff

Crate Responsibilities

Data Flow

Import to Export Pipeline

flowchart LR
    subgraph Input
        CSV[CSV File]
    end

    subgraph "tss-submit"
        MAP[map/]
        NORM[normalize/]
        VAL[validate/]
        EXP[export/]
    end

    subgraph Output
        XPT[XPT V5/V8]
        XML[Dataset-XML]
        DEFINE[Define-XML 2.1]
    end

    CSV --> MAP
    MAP --> NORM
    NORM --> VAL
    VAL --> EXP
    EXP --> XPT
    EXP --> XML
    EXP --> DEFINE

    style CSV fill:#e8f4f8
    style XPT fill:#d4edda
    style XML fill:#d4edda
    style DEFINE fill:#d4edda

Pipeline Stages

Standards Integration

flowchart TB
    subgraph "Embedded CDISC Data"
        SDTM[SDTM-IG 3.4]
        CT[Controlled Terminology]
        DOMAINS[Domain Definitions]
    end

    STANDARDS[tss-standards]
    SDTM --> STANDARDS
    CT --> STANDARDS
    DOMAINS --> STANDARDS
    STANDARDS --> SUBMIT[tss-submit]
    STANDARDS --> INGEST[tss-ingest]
    style STANDARDS fill:#50c878,color:#fff

Key Technologies

Core Stack

External Crates

GUI Architecture

Trial Submission Studio uses Iced 0.14.0 with the Elm architecture pattern:

flowchart LR
    subgraph "Elm Architecture"
        View["View<br/>(render UI)"]
        Message["Message<br/>(user action)"]
        Update["Update<br/>(handle message)"]
        State["State<br/>(app data)"]
    end

    View --> Message
    Message --> Update
    Update --> State
    State --> View

    style View fill:#4a90d9,color:#fff
    style State fill:#50c878,color:#fff

Key GUI components:

• State types: ViewState, Study, DomainState, Settings
• Message enums: Message -> HomeMessage, DomainEditorMessage, DialogMessage
• View functions: Organized by screen (home/, domain_editor/, dialog/)
• Theme: Clinical-style theming with custom color palette

Embedded Data

Standards Directory

standards/
├── sdtm/
│   └── ig/v3.4/
│       ├── Datasets.csv         # Domain definitions
│       ├── Variables.csv        # Variable metadata
│       ├── metadata.toml        # Version info
│       └── chapters/            # IG chapter documentation
├── adam/
│   └── ig/v1.3/
│       ├── DataStructures.csv   # ADaM structures
│       ├── Variables.csv        # Variable metadata
│       └── metadata.toml
├── send/
│   └── ig/v3.1.1/
│       ├── Datasets.csv         # SEND domains
│       ├── Variables.csv        # Variable metadata
│       └── metadata.toml
├── terminology/
│   ├── 2024-03-29/              # CT release date
│   │   ├── SDTM_CT_*.csv
│   │   ├── SEND_CT_*.csv
│   │   └── ADaM_CT_*.csv
│   ├── 2025-03-28/
│   └── 2025-09-26/              # Latest CT
├── validation/
│   ├── sdtm/Rules.csv           # SDTM validation rules
│   ├── adam/Rules.csv           # ADaM validation rules
│   └── send/Rules.csv           # SEND validation rules
└── xsl/
    ├── define2-0-0.xsl          # Define-XML stylesheets
    └── define2-1.xsl

Testing Strategy

Test Types

Test Data

Mock datasets in mockdata/ for:

• Various domain types
• Edge cases
• Validation testing

Next Steps

• Crate Documentation - Individual crate details
• Design Decisions - Architectural choices
• Contributing - Development guide