| name | product-prd |
| description | Generate comprehensive PRDs for Talosix clinical trial EDC features, including regulatory considerations, user stories, and technical requirements. |
| allowed-tools | mcp__claude_ai_Atlassian__searchJiraIssuesUsingJql, mcp__claude_ai_Atlassian__getJiraIssue, mcp__claude_ai_Atlassian__searchConfluenceUsingCql, mcp__claude_ai_Atlassian__getConfluencePage, mcp__claude_ai_Atlassian__createConfluencePage |
| argument-hint | [Feature name or area, e.g. 'ePRO module', 'edit check builder', 'randomization engine'] |
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
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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)
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Generate the PRD using the template below.
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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
