CASafetyReporting object
Sponsor
Legal representative domiciled in the EU/EEA
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
As soon as possible
Within a max of 7d upon first knowledge
As soon as possible
Within a max of 15d upon first knowledge
No, European standard SUSAR reporting form CIOMS-I recommended
CIOMS form available for download on the BASG website
NB: Only to be used if electronic reporting to Eudravigilance is not possible for technical reasons!
Data carrier (USB key)
Paper hardcopy
Other: Electronic reporting in E2B-Format to Pharmacovigilance Database of the European Medicines Agency (EudraVigilance-Clinical Trial Module)
Prerequisite for electronic reporting is the submission of the following form: F I437 SUSAR Ansuchen: Ansuchen um Befreiung von der Meldungsverpflichtung über schwerwiegende Nebenwirkungen gemäß § 41e AMG an das Bundesamt für Sicherheit im Gesundheitswesen (BASG) (de)/ Request for exemption from the notification obligation of SAEs according to Art 41e AMG to BASG) (en)
No further reporting to BASG, as described in Art 41e, will then be required.
Yes
National CA
Not applicable
Yes
L I206 Leitfaden KP Einreichung (de)
L I209 Guidance CT submission (en)
Yes
Art 41d + Art 41e AMG
Dual-reporting of SUSARs must be avoided (EudraVigilance-Clinical Trial Module and BASG); in case of electronic reporting in E2B-Format, no further reporting obligations to CA according to Art 41e apply (e.g Annual safety report). If electronic reporting to Eudravigilance is impossible, then SUSARs reports should be sent in paper (together with supporting documentation on CD, if necessary).
