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: 5.8 Standard operating procedures

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

5.8 Standard operating procedures

Where warranted by the number or scale of clinical trials conducted, it is recommended that the sponsor establish written standard operating procedures (SOP) to comply with Good Clinical Practice.