- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
10.2 Investigational labelling and packaging
The sponsor is responsible for the proper packaging and investigational labelling of the pharmaceutical products used. Study products should be labelled in compliance with the protocol and any applicable national regulations. The investigational label should state that the product is for clinical research purposes only. Investigational label information should be accurate and in a language that is understandable to the subject.
In blinded trials, the package should be labelled in a way that does not reveal the identity of the product. A coding system should be used to allow for the proper identification of the blinded products given to individual subjects (in case of emergency). In addition, all study products, including comparator products, should be indistinguishable by appearance, taste, smell, weight and other physical characteristics.