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close this bookGuidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)
close this folder1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document1.1 Justification for the trial
View the document1.2 Ethical principles
View the document1.3 Supporting data for the investigational product
View the document1.4 Investigator and site(s) of investigation
View the document1.5 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.