Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.): 5. RESPONSIBILITIES OF THE SPONSOR: 5.11 Quality assurance

Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)

5. RESPONSIBILITIES OF THE SPONSOR

		(introductory text...)
		5.1 Selection of the investigator(s)
		5.2 Delegation of responsibilities
		5.3 Compliance with the protocol and procedures
		5.4 Product information
		5.5 Safety information
		5.6 Investigational product
		5.7 Trial management and handling of data
		5.8 Standard operating procedures
		5.9 Compensation for subjects and investigators
		5.10 Monitoring
		5.11 Quality assurance
		5.12 Study reports
		5.13 Handling of adverse events
		5.14 Termination of trial

5.11 Quality assurance

The sponsor should establish a system or systems of quality assurance (including independent auditing) to ensure that the conduct of the clinical trial and the generation, documentation, and reporting of data comply with the protocol, Good Clinical Practice standards and applicable regulatory requirements. The system should operate independently of those involved in conducting or monitoring the trial (see Section 12).