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: 5.13 Handling of adverse events

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

5.13 Handling of adverse events

The sponsor should provide special forms for reporting any adverse event that occur during the clinical trial. The sponsor must investigate promptly, together with the investigator(s), all serious adverse events, take appropriate measures to ensure the safety of trial subjects, and report these events to appropriate authorities in accordance with applicable national requirements (see Section 7).