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product-prd

Generate structured PRDs for clinical trial EDC features using Jira and Confluence context.

1|1|Updated Feb 24, 2026
Search Tags:#jira#confluence#prd#product requirements#regulatory compliance#clinical trials#edc
One-click install
npx skills add https://github.com/nroze22/TalosixSkills --skill product-prd-nroze22
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: product-prd
Source: https://github.com/nroze22/TalosixSkills/tree/main/.claude/skills/product-prd
Command: npx skills add https://github.com/nroze22/TalosixSkills --skill product-prd-nroze22

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill streamlines the creation of Product Requirements Documents (PRDs) for clinical trial Electronic Data Capture (EDC) features, ensuring all necessary regulatory and technical considerations are addressed.

Core Features & Use Cases

  • Automated PRD Generation: Creates structured PRDs including problem statements, user stories, functional and non-functional requirements, regulatory considerations, and technical specifications.
  • Contextual Data Gathering: Integrates with Jira and Confluence to pull relevant information for PRD content.
  • Use Case: When developing a new feature for patient randomization, use this Skill to generate a PRD that covers 21 CFR Part 11 compliance, ICH GCP guidelines, and integration requirements with the Interactive Web Response System (IWRS).

Quick Start

Use the product-prd skill to generate a PRD for the 'ePRO module' feature.

Frequently Asked Questions about product-prd

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I generate a PRD for a clinical trial EDC platform feature?▼

Generate a clinical trial EDC PRD by gathering context from Jira and Confluence, then structuring problem statements, user stories, functional requirements, and release plans into a comprehensive document.

What regulatory compliance requirements should be included in an EDC product requirements document?▼

An EDC product requirements document should incorporate 21 CFR Part 11 compliance, ICH GCP guidelines, and validated system environment requirements to ensure clinical trial software meets regulatory standards.

Can I pull existing Jira and Confluence context into a product requirements document?▼

Yes, you can pull existing Jira and Confluence context into a product requirements document by searching the platforms to gather relevant information for structuring the PRD content.

What sections are needed when writing a PRD for a patient randomization feature?▼

Writing a PRD for a patient randomization feature requires sections on problem statement, goals, user stories, functional, regulatory, technical, UX/UI, non-functional requirements, dependencies, risks, and release plans.

Does this PRD generation approach handle integration requirements with IWRS?▼

Yes, this PRD generation approach handles integration requirements with the Interactive Web Response System (IWRS) alongside regulatory considerations for clinical trial Electronic Data Capture features.

What is the best way to structure non-functional requirements for clinical trial software?▼

The best way to structure non-functional requirements for clinical trial software is to include them as a dedicated section within a comprehensive PRD, covering technical specifications and validated system environment needs.

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