Section 7: Information provided by the promoter

When research involving the human person is conducted in a health establishment, the sponsor must inform the director of the establishment in advance of the research, for information purposes: 1° The title of the research ; 2° The identity of the investigator(s) and the location(s) concerned in the establishment; 3° The date on which it is planned to start the research and its expected duration; 4° The elements of the…

When research involving the human person is conducted in an establishment with an in-house pharmacy, the sponsor must provide the pharmacist in charge of the pharmacy with the following information beforehand: 1° The title and objective of the research ; 2° Where applicable, the information mentioned in 2°, 3° and 4° of article R. 5121-15 for research involving an investigational medicinal product; 3° Where applicable, the investigator’s brochure referred to…

The sponsor must communicate to the investigators of research involving the human person : 1° The protocol for research involving the human person referred to in Article R. 1123-20 ; 2° Where applicable, the pharmaceutical form, batch number(s) and expiry date of the medicinal product(s) required for the research; 3° Where applicable, for the medicinal product required for research, its special or scientific name or its code name, its qualitative…