- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.7 Site of the trial, facilities and staff
Clinical trials must be carried out under conditions which ensure adequate safety for the subjects. The site selected should be appropriate to the stage of development of the product and the potential risks involved. The trial site must have adequate facilities, including laboratories, equipment and sufficient medical, paramedical, and clerical staff to support the trial and to deal with all reasonable foreseeable emergencies. All laboratory assays must be validated, and principles of Good Laboratory Practice (GLP) should be observed.
The investigator should ensure that he or she has sufficient time to conduct and complete the trial, and that other commitments or trials do not divert essential subjects, resources or facilities away from the trial in hand.
The investigator must provide adequate information to all staff involved in the trial.
The investigator must notify or obtain approval for the trial from relevant local hospital (medical, administrative) management in compliance with existing regulations.