Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.): 4. RESPONSIBILITIES OF THE INVESTIGATOR: 4.17 Trials in which the investigator is the sponsor

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

4. RESPONSIBILITIES OF THE INVESTIGATOR

		4.1 Medical care of trial subjects
		4.2 Qualifications
		4.3 Selection of trial subjects
		4.4 Compliance with the protocol
		4.5 Information for subjects and informed consent
		4.6 The investigational product
		4.7 Site of the trial, facilities and staff
		4.8 Notification of the trial or submission to the drug regulatory authority
		4.9 Review by an ethics committee
		4.10 Serious adverse events/reactions
		4.11 Financing
		4.12 Monitoring, auditing and inspection
		4.13 Record-keeping and handling of data
		4.14 Handling of and accountability for pharmaceutical products for trial
		4.15 Termination of trial
		4.16 Final report
		4.17 Trials in which the investigator is the sponsor

4.17 Trials in which the investigator is the sponsor

In clinical trials in which the investigator is the sponsor, he or she is responsible for the corresponding functions (see Section 5).