1. februar 2017

Reporting of adverse reactions, completion of trials, etc.

Reporting of adverse reactions (in health scientific research projects not involving medicinal products)

Serious unexpected adverse reactions or events

The chief investigator or sponsor must immediately inform the committee if suspected unexpected serious adverse reactions or serious events occur during the project. The report must include comments on any outcomes for the concerned trial.

Only adverse reactions and events occurring in Denmark must be reported.

Reporting must take place no later than 7 days after the sponsor or the chief investigator became aware of any such adverse reactions or events.

In case of serious adverse reactions or serious events resulting from the project, the chief investigator must make available any information requested by the committee.

The report can be made using a particular form prepared by the committee system. The form is in Danish and downloadable on the right-hand side of the page. The form and attachments can be submitted electronically to the regional research ethics committee using digital signature.

Annual report

Once every year and throughout the trial period, the chief investigator must submit a list of all serious expected and unexpected adverse reactions and all serious events having occurred in the period. Enclosed with the report must be an assessment of the trial subjects' safety.

The reported material can be in either Danish or English.

The report must be made using a form prepared by the committee system. The form is in Danish and downloadable on the right-hand side of the page. The form and attachments can be submitted electronically to the regional research ethics committee using digital signature.

The reporting duty also applies to trials of medical devices.

The reporting duty in clinical trials of medicinal products

In regard to authorised projects notified before 1 January 2012, adverse reactions must be reported pursuant to section 22 of Act no. 402 of 28 May 2003 on a Scientific Ethical Committee System and the Processing of Biomedical Research Projects as amended. However, chief investigators and sponsors who want to organise their work according to the present rules can report adverse reactions pursuant to the following passages.

Serious unexpected adverse reactions

The chief investigator or the sponsor must immediately inform the committee if suspected unexpected serious adverse reactions (SUSARs) occur during the course of the project. The reporting duty applies to SUSARs occurring in Denmark.

It is possible to use the same form used for reporting SUSARs to the Danish Health and Medicines Authority in clinical trials of medicinal products. In terms of content, reports of SUSARs to the committee system must otherwise comply with the Danish Health and Medicines Authority's clinical trial guidelines, sections 12.1 and 12.3 on reporting of adverse reactions. It is possible to use the Danish Health and Medicines Authority’s form available from the authority’s website: Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials (e-form).

Annual report

Once every year and throughout the trial period, the sponsor or the chief investigator must moreover submit a list of all serious expected and unexpected adverse reactions having occurred in the period. Enclosed with the report must be an assessment of the trial subjects' safety.

The annual report and list of all suspected serious adverse reactions can be replaced by the Development Safety Update Report (DSUR, ICH E2F).

The annual report to the committee system must otherwise comply with the Danish Health and Medicines Authority's clinical trial guidelines, section 12.4 on reporting of adverse reactions.

Report format (clinical trials of medicinal products)

The committee must receive SUSARs and annual reports in PDF format. The reports must be submitted electronically (encrypted).

It is possible to generate SUSAR reports in PDF in connection with reporting via the Eudravigilance Database (e.g. CIOMS report) or when using the Danish Health and Medicines Authority's e-form for "Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials" (Before submitting the e-form, it can be printed out and subsequently submitted in PDF format).

It is the Danish Health and Medicines Authority that supervises clinical trials of medicinal products.

The committee system has prepared a number of questions and answers about reporting of adverse reactions in clinical trials (in Danish only).

Reporting duty at trial completion (all types of trials)

The chief investigator and the sponsor must jointly inform the committee no later than 90 days after completion of a project. The project is considered completed on the date of the last trial subject observation.

Project completion can be notified using a form prepared by the committee system. The form is in Danish and downloadable on the right-hand side of the page. The form can be submitted electronically to the regional ethics committee using digital signature.

If a project is terminated earlier than planned, the committee must be informed thereof within 15 days from the time when the decision to terminate the project was made. An explanation must be given for termination. Pursuant to section 31(2) of the Danish Committee Act, the committee may demand the chief investigator or the sponsor to submit a reasoned explanation.