Version 1.0 - February 2019

Side Effects

1. Reporting of Adverse Effects (Pharmaceutical Trials)

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.

Annual reports must be submitted 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 the submission format).

2. Reporting of side effects (non-drug trials)

2.1 Serious Unexpected Side Effects or Events

The person responsible for the trial or the sponsor must immediately notify the committee if any suspected serious unexpected side effects or serious events arise during the project. The report must be accompanied by comments on any consequences for the trial.

Only side effects and events that have occurred in Denmark must be reported.

Notification must be made no later than 7 days after the sponsor or the person responsible for the trial becomes aware of the case.

If it concerns serious side effects or serious events that are a consequence of the project, the person responsible for the trial must provide the information requested by the committee.

For the report, a form prepared by the committee system can be used. The form with attachments can be electronically sent to the regional scientific ethics committee using a digital signature. Download the form here: Reporting Form.

2.2 Annual Report

Once a year throughout the trial period, the person responsible for the trial must submit a list of all serious expected and unexpected side effects and all serious events that have occurred during the period. The report must be accompanied by an assessment of the safety of the trial participants.

The reporting material must be in Danish or English.

The Reporting Form can be used for the report. The form with attachments can be electronically sent to the regional scientific ethics committee using a digital signature. (Note that the regional scientific ethics committees have different requirements for the submission method).

The reporting obligation also applies to trials with medical equipment.

3. Rules and guidelines

Frequently Asked Questions

Reports of both suspected serious unexpected side effects (SUSARs) and annual reports of suspected serious side effects must be sent to the regional committee that approved the project. The National Scientific Ethics Committee does not need to receive side effect reports.

The annual list of all suspected serious (both expected and unexpected) side effects should be accompanied by a report assessing the safety of the research participants. This is the same report (and list) that is reported to the Danish Medicines Agency. Reference is made to the guidelines for reporting side effects arising from clinical trials (CT3), section 8. The annual report and list of suspected serious side effects can be replaced by the Development Safety Report (DSUR). More about DSUR can be found below in question and answer no. 5.

No, the annual report covers all suspected serious side effects observed in the study in all countries.

Both the reporting of SUSARs and the annual report can be done in English. Therefore, the report no longer needs to be accompanied by a Danish cover letter or an independent Danish assessment of the safety of the trial participants.

DSUR stands for Development Safety Update Report. It is a common standard for annual reporting of side effects developed by ICH for use in the USA, Europe, and Japan. You can learn more about ICH here. The annual report and list of suspected side effects can be replaced by the Development Safety Update Report. For more information on DSUR, you can refer to ICH's guidelines (ICH E2F).

Incidents should not be reported in connection with the annual reporting of side effects. However, they should be included in the final report on the study's outcome, which must be submitted to the Danish Medicines Agency no later than one year after the study's conclusion. The final report or a summary/synopsis of it can also be used to report the final publication/report to the regional scientific ethics committee. Read more about Reporting at the End of Trials.

The annual reporting obligation applies as long as the treatment of study participants is ongoing in Denmark (see CT3 section 8). The treatment is considered to end at the "last visit of the last patient" (in Denmark).

The reporting obligation ends when the study concludes in Denmark. This is understood as the "last visit of the last patient" (in Denmark).

Last updated 01-02-2024

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