incident-response

name	incident-response
description	Production incident response framework for Talosix EDC systems. Covers severity classification with patient safety considerations, investigation steps, root cause analysis, communication templates, and CAPA follow-up.
allowed-tools	Read, Grep, Glob, Bash

Incident Response Skill

Guide production incident response for Talosix EDC clinical trial systems. Clinical trial systems have unique incident response requirements because system failures can impact patient safety, data integrity, and regulatory compliance.

When to Use

• A production incident has been reported or detected
• Drafting an incident response plan for a new system
• Conducting post-incident review and root cause analysis
• Preparing CAPA documentation after an incident

Severity Classification

Clinical Trial System Severity Matrix

Severity	System Impact	Clinical Impact	Examples
SEV-1: Critical	System unavailable or data integrity compromised	Patient safety risk or regulatory non-compliance	Data corruption in eCRFs; audit trail failure; system-wide outage during active data collection; e-signature system failure
SEV-2: High	Major feature unavailable, no workaround	Clinical workflow blocked for multiple sites	Form submission failures; randomization integration down; data export broken; query workflow non-functional
SEV-3: Medium