Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.): 1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL: 1.1 Justification for the trial

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

1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL

		1.1 Justification for the trial
		1.2 Ethical principles
		1.3 Supporting data for the investigational product
		1.4 Investigator and site(s) of investigation
		1.5 Regulatory requirements

1.1 Justification for the trial

It is important for anyone preparing a trial of a medicinal product in humans that the specific aims, problems and risks or benefits of a particular clinical trial be thoroughly considered and that the chosen options be scientifically sound and ethically justified.