1.1 Serious Unexpected Adverse Reactions
The responsible investigator or sponsor must immediately notify the committee if suspected serious unexpected adverse reactions (SUSARs) occur during the project.
SUSARs that are fatal or life-threatening must be reported to the committee (and the Danish Medicines Agency) as soon as possible and no later than 7 days after the sponsor or responsible investigator becomes aware of such a suspected adverse reaction. Within 8 days of the report, the sponsor must inform the committee (and the Danish Medicines Agency) of all relevant information regarding the sponsor's and investigator's follow-up on the report.
All other unexpected and serious suspected adverse reactions must be reported to the Danish Medicines Agency and the committee no later than 15 days after the sponsor becomes aware of them.
The report must be accompanied by comments on any consequences for the trial.
The obligation to report to the committee includes SUSARs that have occurred in Denmark.
Only unexpected adverse reactions are subject to the immediate reporting obligation. An unexpected adverse reaction is a reaction whose nature or severity does not correspond to the risk described in the trial protocol for the given activity.
Reports of SUSARs to the committee system must also follow the content requirements of the Danish Medicines Agency's guidance on clinical trials, sections 12.1 and 12.3 on reporting of adverse reactions. See the Danish Medicines Agency's guidance.
The committee must receive SUSARs and annual reports in the form of a PDF report. The report must be submitted electronically (encrypted). (Note that the regional scientific ethical committees have different requirements for submission format).
SUSAR reports in PDF format can be generated either in connection with reports made to the Eudravigilance database (e.g., CIOMS report) or by using the Danish Medicines Agency's e-form for reporting suspected unexpected and serious adverse reactions (SUSARs) seen in clinical trials (Before sending the e-form, there is an option to print the e-form, which can then be submitted in PDF format).
The Danish Medicines Agency is responsible for controlling pharmaceutical trials.
1.2 Annual Reporting
The sponsor or responsible investigator must also submit an annual list of all suspected serious expected and unexpected adverse reactions that have occurred during the trial period. The report must be accompanied by an assessment of the safety of the trial participants.
The annual report and list of all suspected serious adverse reactions can be replaced by the Development Safety Update Report (DSUR, see ICH E2F).
The annual report to the committee system must also follow the Danish Medicines Agency's guidance on clinical trials, section 12.4 on reporting of adverse reactions.
The annual report to the committee system must also follow the Danish Medicines Agency's guidance on clinical trials, section 12.4 on reporting of adverse reactions.