Product Prd

Product Requirements Document Generator

Generate structured, comprehensive PRDs for Talosix EDC platform features. All PRDs must account for clinical trial regulatory requirements and the validated system environment.

Workflow

1. Gather Context: Ask the user for the feature name/area. Then pull relevant context:

   • Search Jira for related epics, stories, and feature requests using searchJiraIssuesUsingJql
   • Search Confluence for existing specs, research, or prior PRDs using searchConfluenceUsingCql
   • Ask the user for any additional context (customer requests, competitive pressure, regulatory drivers)

2. Generate the PRD using the template below.

3. Offer to publish the PRD to Confluence using createConfluencePage.

PRD Template

Structure every PRD with these sections:

Header

• Title: PRD: [Feature Name]
• Author: [User name]
• Date: [Current date]
• Status: Draft | In Review | Approved
• Target Release: [Version/Quarter]
• Stakeholders: List key stakeholders (PM, Engineering, QA, Regulatory, Clinical)

1. Problem Statement

• What problem does this solve for clinical trial stakeholders (sponsors, CROs, sites, monitors)?
• Who experiences this problem and how frequently?
• What is the cost of not solving it (delays, errors, compliance risk)?

2. Goals and Success Metrics

• Primary goal and measurable outcomes
• Key metrics: adoption rate, time savings, error reduction, compliance improvement
• EDC-specific metrics: data entry time, query resolution time, database lock timeline

3. User Stories

Write user stories for each persona:

• Site Coordinator: "As a site coordinator, I want to... so that..."
• Clinical Data Manager: "As a CDM, I want to... so that..."
• Medical Monitor: "As a medical monitor, I want to..."
• Sponsor/CRO Project Manager: "As a sponsor PM, I want to..."
• System Administrator: "As an admin, I want to..."

4. Functional Requirements

• Numbered list of requirements (REQ-001, REQ-002, etc.)
• Each requirement: description, priority (Must/Should/Could), and rationale
• Include data model changes, API requirements, UI changes

5. Regulatory Considerations

Address these for every feature:

• 21 CFR Part 11 compliance: Electronic signatures, audit trails, access controls
• ICH E6(R2) GCP: Data integrity, source data verification
• EU Annex 11: Computerized systems validation requirements
• GDPR/Privacy: Personal data handling, consent, data subject rights
• Audit trail requirements: What actions must be logged with timestamps and user IDs
• Electronic signature requirements: Does this feature require Part 11 compliant e-signatures?
• Data integrity (ALCOA+): Attributable, Legible, Contemporaneous, Original, Accurate

6. Technical Requirements

• System architecture impacts
• Integration points (CDASH, CDISC ODM, HL7 FHIR, third-party labs, IRT)
• Performance requirements (concurrent users, response times)
• Data migration considerations
• API specifications (REST endpoints, payload schemas)

7. UX/UI Requirements

• Wireframes or mockup descriptions
• Accessibility requirements (WCAG 2.1 AA)
• Multi-language/localization needs
• Mobile/tablet considerations for site users

8. Non-Functional Requirements

• Performance: page load times, concurrent user support
• Security: role-based access, encryption, session management
• Scalability: multi-study, multi-site deployment
• Availability: uptime SLA targets
• Validation: IQ/OQ/PQ requirements, test documentation

9. Dependencies and Risks

• Technical dependencies (infrastructure, third-party services)
• Cross-team dependencies
• Regulatory risks and mitigation strategies
• Timeline risks

10. Release and Rollout Plan

• Phased rollout strategy
• Validation and UAT requirements
• Training needs for site users, data managers, monitors
• Documentation updates (user guides, validation docs, SOPs)

11. Open Questions

• List unresolved questions with owners and target resolution dates

Domain Guidance

When generating PRDs for common EDC features, include these domain-specific considerations:

• eCRF Design: CDASH standards, visit scheduling, conditional branching, edit checks
• Data Import/Export: CDISC ODM, SAS datasets, CSV, API integrations
• Query Management: auto-queries, manual queries, query workflows, resolution tracking
• Randomization: IWRS integration, stratification, blinding requirements
• ePRO/eCOA: device provisioning, offline capability, compliance windows
• Safety/SAE: MedDRA coding, expedited reporting timelines, E2B(R3)
• Monitoring: remote monitoring, SDV workflows, risk-based monitoring support
• Reporting: study dashboards, enrollment tracking, data quality metrics