CASafetyReporting object
Sponsor
Legal representative domiciled in the respective country
Only SUSARs observed at Swiss trial centres
Within 7 days for SUSARs resulting in death
Within a max of 15d upon first knowledge
No, European standard SUSAR reporting form CIOMS-I recommended
CIOMS form, always together with the accompanying form for SUSARs
In electronic form (not by fax!)
Yes
National CA (for Cat B and C trials)
Further information, instruction and standard reporting forms available on the Swissmedic website in the section: Licenses > Clinical trials on medicinal products > Safety measures in clinical trials.
Address for SUSAR notification: SUSAR(at)swissmedic.ch
!NB: Specific AE reporting requirements apply to clinical trials with Transplant Products, Gene Therapy and GMO:
All fatal cases, SUSARs and SADRs from Switzerland and abroad must be reported to the CA by the sponsor. SUSARs being life-threatening or leading to death: within 7 days; SADRs and other events requiring notification: within 15 days.
Further details and standard reporting forms are provided on the Swissmedic website: Licenses > Clinical trials on gene therapy/GMO)
Sponsor
Immediately (without delay)