SSQualityAssurance object
Monitoring
Compulsory
Audit by sponsor
Compulsory
Standard Operating Procedures (SOPs)
Compulsory
Additional Information
The quality control related to the Good Clinical Practice can be performed by the Clinical Trials Inspectorate according to the Art. 37ae of the Pharmaceutical Law.
The President of URPL informs EMA about the results of the control of a clinical trial. The report from the control can be available to EMA, EU or EFTA countries and the local EC, if officially requested.
