CASafetyReporting object

Sponsor

National CA

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

Immediately
Within a max of 7d upon first knowledge (+ 8d for additional information)

Immediately
Within a max of 15d upon first knowledge

Yes
Other

• Non-commercial sponsors:
(1) Standard e-form to be used: Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials. OR
(2) CIOMS Form (provided in Annex 9 of "Guideline for applications for authorisation of clinical trials of medicinal products in humans" available on the DKMA website)

• Commercial Sponsors:
(1) Standard e-form to be used: Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials OR
(2) Via EudraVigilance (if registered)

Electronically

Yes

Yes

Further details are available on the DHMA website in section: 'Reporting of adverse reactions in clinical trials' and in the 'Guideline for applications for authorisation of clinical trials of medicinal products in humans'-

89(2i)+(2iii) of Danish Medicines Act

SUSARs arising from clinical trials with the same protocol (same EudraCT number) in other EU countries must also be reported to the CA. The DHMA forwards all reported SUSARs to EudraVigilance, so that they are included in the complete European adverse reaction data for the product concerned.

Annual safety report: list of all serious suspected adverse reactions and a report on trial subject safety .

Relevant EC(s)
Sponsor

Immediately