- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
1.4 Investigator and site(s) of investigation
Each investigator should have appropriate expertise, qualifications and competence to undertake a proposed study. Prior to the trial, the investigator(s) and the sponsor should establish an agreement on the protocol, standard operating procedures (SOP), the monitoring, and auditing of the trial, and the allocation of trial-related responsibilities. The trial site should be adequate to enable the trial to be conducted safely and efficiently (see chapter 4.7).