dvp-composer

DVP Composer

Data Validation Plan (DVP) composition assistant for clinical trial Data Management.

Overview

DVP Composer is a Claude Code plugin designed for Data Managers at CROs and sponsors. It guides you through a structured, interactive workflow to compose a complete Data Validation Plan for clinical trials — from collecting protocol materials to generating a formatted Excel deliverable.

Features

• 6-Phase Interactive Workflow — Collection → Scope & Strategy → Design Checks → Alignment → Draft → Internal Review
• Two-Level Task Tracking — Phase-level roadmap at startup, sub-task breakdown within each phase for clear progress visibility
• Unified Interaction Protocol — Structured decision framework (Self-decide / Recommend / Must-ask) with four question types (Collect, Confirm, Conflict, Done)
• Multiple Input Methods — Paste text, provide file paths (PDF/Word/Markdown), or answer Q&A-style prompts
• Excel Output — Generates formatted .xlsx with Check List, Summary, Revision History, and External Data Reconciliation sheets
• Template Support — Use your own DVP Excel template or the default 4-sheet format
• Built-in Quality Review — Dedicated reviewer agent that checks completeness, consistency, logic, and quality before finalization

Workflow

Phase	Name	Description
1	Collection	Gather protocol, CRF, SAP and other input materials; understand study context
2	Scope & Strategy	Define validation scope, identify key variables and risk points, assign validation methods
3	Design Checks	Design specific, executable check rules for each data module
4	Alignment	Verify rules are correct, feasible, and not conflicting with existing systems
5	Draft	Compile all content into a structured DVP document and generate Excel output
6	Internal Review	Comprehensive review for completeness, consistency, and clarity

Task Tracking

When the workflow starts, 6 phase-level tasks are created with chained dependencies, giving you a full roadmap. As each phase begins, its sub-steps are broken down into individual tasks — so you always know what's done and what's next.

Quick Start

Prerequisites

• Python 3.8+
• openpyxl: pip install openpyxl

Install

Add the plugin to your Claude Code environment:

claude install-plugin /path/to/dvp-composer

Or copy the project directory into .claude-plugin/ in your working directory.

Trigger

In Claude Code, use any of the following:

/dvp-composer

Or describe your need naturally:

• "compose DVP"
• "create a Data Validation Plan"
• "I need to write a DVP for my study"
• "帮我写一个 DVP"

Then follow the interactive prompts through each phase.

Project Structure

dvp-composer/
├── .claude-plugin/
│   └── plugin.json                        # Plugin manifest
├── CLAUDE.md                              # Claude Code instructions
├── README.md
└── skills/dvp-composer/
    ├── SKILL.md                           # Main skill definition & workflow orchestration
    ├── agents/
    │   └── dvp-reviewer.md                # Quality review agent for Phase 6
    ├── scripts/
    │   └── generate_xlsx.py               # Excel generation script
    └── references/
        ├── stages/
        │   ├── phase-1-collection.md      # Phase 1 instructions
        │   ├── phase-2-strategy.md        # Phase 2 instructions
        │   ├── phase-3-design.md          # Phase 3 instructions
        │   ├── phase-4-alignment.md       # Phase 4 instructions
        │   ├── phase-5-draft.md           # Phase 5 instructions
        │   └── phase-6-review.md          # Phase 6 instructions
        ├── excel-spec.md                  # Excel output format specification
        ├── section-catalog.md             # Standard DVP document structure
        └── example-output.md              # Example DVP output with sample checks

License

MIT