Section 7: Information provided by the promoter

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 and quantitative composition in terms of active ingredients and excipient constituents, knowledge of which is necessary for correct administration of the medicinal product, using the international non-proprietary names where they exist or, failing that, the names of the European or French pharmacopoeia;

4° Where applicable, for a placebo, its composition;

5° The information that will be given, in application of Article L. 1122-1, to the persons asked to take part in the research and the procedures for obtaining the consent of these persons, including the document or documents that will be given to them;

6° A copy of the insurance certificate;

7° Where applicable, the exclusion period referred to in article L. 1121-12 ;

8° The opinion of the personal protection committee consulted on the project in application of article L. 1123-6, if the investigator does not already have one;

9° Where applicable, the investigator's brochure referred to in article R. 1123-20, together with the references of the principal works used for this summary;

10° Where applicable, the references of any marketing authorisations obtained in France or abroad for the medicinal product and any decisions to refuse, suspend or withdraw such authorisations;

11° The identity of the other investigators taking part in the research and the places where they carry out their work;

12° The authorisation of the competent authority provided for in articles L. 1123-8 and L. 1124-1;

13° Where applicable, the batch/serial number or unique code, and where applicable the expiry date of the medical devices or in vitro diagnostic medical devices being investigated and, if available, their instructions for use.

The investigators may ask the sponsor for any additional documents or research if they consider that the information provided is not sufficiently enlightening.

The sponsor will send the investigators any updates to the information initially provided.