Subsection 1: Vigilance.

For the purposes of this section, the following definitions shall apply

1° Adverse event, any noxious occurrence in a person who undergoes research involving the human person, whether or not this occurrence is related to the research or to the product to which this research relates;

2° Adverse reaction: any undesirable event occurring in a person who undergoes research involving the human person, when this event is related to the research or to the product to which this research relates;

3° Adverse effect of an investigational medicinal product, any noxious and undesirable reaction to an investigational medicinal product whatever the dose administered. This definition also applies to cell therapy preparations as defined in Article L. 1243-1 ;

4° Undesirable effect of a medical device or an in vitro diagnostic medical device, any noxious and undesired response to a medical device or any incident which could have caused such a response if appropriate action had not been taken, in a person undergoing research or in the user of the medical device or any effect linked to a failure or an alteration of an in vitro diagnostic medical device and harmful to the health of a person undergoing research;

5° Adverse effect of a cosmetic product or a tattoo product, any harmful and undesired reaction occurring with the cosmetic product tested or the tattoo product tested;

6° Serious undesirable effect of a cosmetic product or a tattooing product: any undesirable effect resulting in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, immediate vital risk or death;

7° Serious adverse event or reaction: any adverse event or reaction which results in death, endangers the life of the person undergoing the research, requires hospitalisation or prolongation of hospitalisation, causes significant or lasting disability or handicap, or results in a congenital anomaly or malformation, and in the case of medicinal products, regardless of the dose administered. This definition does not apply to the products mentioned in article R. 1211-29 and to labile blood products;

8° For research involving a medicinal product, unexpected adverse reaction: any adverse reaction to the product whose nature, severity, frequency or course are not consistent with the reference safety information given in the summary of product characteristics or in the investigator's brochure when the product is not authorised;

9° For other research involving the human person, unexpected adverse reaction: any adverse reaction whose nature, severity or course is not consistent with the information relating to the products, procedures performed and methods used during the research;

10° For research involving the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the definitions mentioned in Article R. 1211-31 apply;

11° For research involving the human person relating to labile blood products, the definitions given in Article R. 1221-23 are applicable;

12° For research involving the human person, new fact: any new data that may lead to a reassessment of the risk-benefit ratio of the research or of the product that is the subject of the research, to changes in the use of this product, in the conduct of the research, or in the documents relating to the research, or to the suspension, interruption or modification of the research protocol or similar research. For trials involving the first administration or use of a health product in people with no medical condition: any serious adverse reaction.