Module 5 Presentations

Types of Organisations Inspected

Commercial sponsors Non-commercial sponsors (academia, charities, NHS) Investigator sites

Contract Research Organisations (CROs) Specialist providers (e.g. eSystem Vendors) Laboratories Non-commercial Clinical Trial Units Phase 1 units Bioequivalence/Biosimilar facilities

11

11

Inspection Process

Notification and Data Requests

Facility Review

Systems Review

Inspection

Interview

Report, CAPA and Closure

Data Review

12

12

6