ECSafetyReporting object

SUSAR (Suspected Unexpected Serious Adverse Reaction) occurring in the respective country

Relevant EC(s)
Sponsor

Immediately

Sponsor
Investigator

Yes

Reporting options:
(1) via the Eudravigilance Database (e.g. CIOMS report)
(2) it is possible to use the Danish Health and Medicines Authority’s e-form, available from the authority’s website: Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials (e-form.)
(3) Standard form available and downloadable on the website of the National Research EC in Section: Reporting of adverse reactions, completion of trials, etc.

Yes

Yes

SUSAR reports to the committee system must comply with the Danish Health and Medicines Authority's clinical trial guidance 'Guideline for applications for authorisation of clinical trials of medicinal products in humans' (sections 12.1 and 12.3 on reporting of adverse reactions).

Section 30(1)&(2) of the Committee Act

Reporting Format: as Pdf, electronically (encrypted) or on CD-ROM.
The reported material can be in either Danish or English

Once every year during the entire trial period, an Annual Safety Report (providing a list of all SUSARs encountered during the period + information about the safety of the trial subjects) or a Development Safety Update Report (DSUR, ICH E2F) shall be submitted by the sponsor or the investigator to the regional EC in all kinds of clinical trials
(pursuant to Section 30(2) of the Committee Act)