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: 5.12 Study reports

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

5.12 Study reports

The sponsor is responsible for ensuring the preparation and appropriate approval(s) of a comprehensive final clinical study report suitable for regulatory purposes, whether or not the trial has been completed. The sponsor must also submit any relevant safety information (including safety) that becomes available during the trial and/or annual reports as required by the relevant health authorities.