The Log Form: Serious Breach Assessment provides a structured, inspection-ready format for documenting, investigating, and reporting serious breaches in accordance with ICH, EMA, and MHRA guidance.

It ensures that all incidents with potential impact on patient safety, data credibility, or ethical compliance are recorded, evaluated, and closed under full QA oversight.
 
This form is professionally written and pre-filled (≈ 99% complete), requiring only your company details and QA signature before implementation.

It integrates seamlessly with your Serious Breach SOP, CAPA SOP, and Deviation Management SOP, providing full traceability from identification to closure.
 
Includes:
Fields for breach identification and reporting timelines
Reporter, organization, and contact information
Study and investigational product details
Sections for initial and follow-up reporting
Impact assessment on patient safety, scientific integrity, and confidentiality
Documentation of investigations, outcomes, and CAPA actions
QA approval and final closure section
 
This log form demonstrates regulatory diligence and sponsor oversight, ensuring your organization can provide documented evidence of timely, compliant breach management during inspections or audits.