This Regulation applies to inspections of:
clinical trials conducted in the Union, including clinical trial sites related to those trials but located outside the Union;
clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of Regulation (EU) No 536/2014;
clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.
Inspections may take place in any of the following circumstances:
before, during or after the conduct of a clinical trial;
as part of the verification of applications for marketing authorisation;
as a follow-up to the granting of a marketing authorisation.
1.Each Member State shall set up a properly designed quality system ensuring that the inspection procedures are observed and consistently monitored.
Member States shall maintain those quality systems up to date.
2.Each inspector shall have access to and comply with standard operating procedures, details of their duties, responsibilities and training requirements.