AI Deviation Report Platform

Deviation Template

Severity

Regulatory Impact

Study ID

Site ID

Patient/Subject ID

Study Phase

Product

Indication

Impact Category

Detection Method

Detected By

Root Cause Category

Country / Region

Clinical / Operational Context (important)

Open any previous deviation and export again.

Timestamp	Template	Study	Patient	Severity	Reg. Impact
2025-12-23T15:47:50	CAR-T Patient Redosing	CART-021	SUBJ-007	Major	Potential	View
2025-12-23T15:44:32	CAR-T Patient Redosing	CART-021	SUBJ-007	Major	Potential	View
2025-12-23T15:35:09	CAR-T Patient Redosing	CART-021	SUBJ-007	Major	Potential	View
2025-12-23T15:15:37	CAR-T Patient Redosing	CART-021	SUBJ-007	Major	Potential	View
2025-12-22T09:45:37	CAR-T Patient Redosing	CART-021	SUBJ-007	Major	Potential	View
2025-12-19T16:59:40	CAR-T Patient Redosing	CART-021	SUBJ-007	Major	Potential	View