SSQualityAssurance object
Monitoring
Compulsory
Audit by sponsor
Not specified
Standard Operating Procedures (SOPs)
Not specified
Additional Information
Royal Decree 1090/2015
Ordinance SCO/256/2007 contains information regarding GCP and, therefore, compliance with a Quality Assurance system.
Quality Assurance aspects (e.g. Monitoring and Audits) are also listed in chapter 5 ICH-GCP.
