CASafetyReporting object

Sponsor
Legal representative domiciled in the EU/EEA

Competent Authority

Yes

SUSAR (Suspected Unexpected Serious Adverse Reaction)
Other
New event (see definition below)

Immediately (without delay)
Other
Without delay if Healthy Volunteers (whatever the clinical trial phase)

Within a max of 15d upon first knowledge
Other
Without delay if Healthy Volunteers (whatever the clinical trial phase)

Other
Without delay if Healthy Volunteers

Yes

Email
Email: declarationsusars(at)ansm.sante.fr)

Email

National CA

Yes

Detailed guidance on safety reporting procedure and format is available in English and French on the ANSM website in section Déclaration des effets indésirables (SUSARs):
"Explanatory note : Clinical Trial Vigilance Data Reporting (SUSARs) (en)"/ "Fiche explicative : Déclaration des données de vigilance des essais cliniques (fr)"

Yes

Articles R1123-45 - R1123-61 of the Public Health Code
Decree n° 2016-1537 of November 16th, 2016 concerning research involving human beings
Decree n° 2017-884 of May 9th, 2017 modifying certain regulatory provisions concerning research involving human beings

According to Article R1123-46, 12° of the Public Health Code, a NEW EVENT is defined as :
All new data that may lead to :

- the reassessment of the risk-benefit balance of the research or of the product being evaluated,
- the modification of the product utilization,
- the modification of the conduct of research or of the research related documents, or
- the suspension, interruption or modification of the research protocol or similar research protocols.

For studies on the first administration or utilization of a health product on a healthy person: all serious adverse events.