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incident-response

Classify and investigate production incidents in Talosix EDC clinical trial systems.

1|1|Updated Feb 24, 2026
Search Tags:#root cause analysis#incident response#clinical trials#CAPA#patient safety#EDC systems
One-click install
npx skills add https://github.com/nroze22/TalosixSkills --skill incident-response-nroze22
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: incident-response
Source: https://github.com/nroze22/TalosixSkills/tree/main/.claude/skills/incident-response
Command: npx skills add https://github.com/nroze22/TalosixSkills --skill incident-response-nroze22

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

What problem does it solve?

This Skill provides a structured framework to manage and resolve production incidents in clinical trial Electronic Data Capture (EDC) systems, ensuring patient safety and data integrity.

Core Features & Use Cases

  • Severity Classification: Defines clear criteria for classifying incidents based on system and clinical impact, including patient safety considerations.
  • Incident Response Procedure: Outlines a phased approach from detection and triage to investigation, resolution, and post-incident activities.
  • Root Cause Analysis: Offers frameworks like "5 Whys" and Fishbone diagrams to identify underlying causes.
  • CAPA Follow-Up: Guides the process for Corrective and Preventive Actions when required.
  • Communication Templates: Provides pre-written templates for internal and external incident notifications.
  • Use Case: When a critical system outage occurs during a clinical trial, this Skill helps the incident commander quickly classify the severity, assemble the right team, investigate the root cause, and communicate effectively to stakeholders and regulatory bodies.

Quick Start

Use the incident-response skill to classify a new production incident and follow the recommended investigation steps.

Frequently Asked Questions about incident-response

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

FAQPage Schema
How do I manage incident response for EDC systems used in clinical trials?▼

Incident response for EDC systems requires a phased procedure covering detection, triage, investigation, and resolution to protect patient safety and data integrity. This Skill guides you through severity classification and structured communication templates.

What is the best way to classify EDC system incident severity regarding patient safety?▼

Classifying incident severity involves evaluating clinical impact alongside system downtime to determine patient safety risks. This Skill defines clear criteria to categorize production failures and trigger appropriate regulatory and stakeholder notifications.

How do I conduct root cause analysis for clinical trial software outages?▼

Root cause analysis for clinical software outages uses frameworks like 5 Whys and Fishbone diagrams to identify underlying system failures. This Skill applies these methods to isolate issues affecting data integrity and regulatory compliance.

When do I need CAPA follow-up after resolving a production incident?▼

CAPA follow-up is required when a production incident impacts data integrity or regulatory compliance, ensuring corrective and preventive actions are documented. This Skill outlines the process for executing CAPA after clinical trial system failures.

Does this incident response framework apply to critical system failures impacting regulatory compliance?▼

Yes, this framework specifically addresses critical system failures that impact regulatory compliance and patient safety in clinical trials. It provides structured communication templates and investigation steps designed for EDC environments.

How do I communicate with stakeholders during an EDC system outage?▼

Communicating during an EDC system outage requires pre-written notification templates to alert stakeholders and regulatory bodies effectively. This Skill provides these templates to ensure accurate, timely updates throughout the incident response lifecycle.

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