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: 5.9 Compensation for subjects and investigators

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

5.9 Compensation for subjects and investigators

As required by national law or regulations, the sponsor should provide adequate compensation or treatment for subjects in the event of trial-related injury or death, and provide indemnity for the investigator, except in the case of claims resulting from malpractice and/or negligence. (See Section 3.2 (e)-(f)).