Clinical trials sponsors are obliged to immediately report suspected unexpected serious adverse reactions (SUSARs) that arise in clinical trials.
The rules for reporting to the Danish Health and Medicines Authority (according to Danish law and article 17 of Directive 2001/20/EC) are as follows:
- Sponsors are only obliged to report SUSARs in clinical trials if an application for authorisation of the trial has been submitted after 1 May 2004 (cf. the Act to amend the Danish Medicines Act and the Danish Act on Pharmacy Practice, no. 382 of 28 May 2003, Danish title: "Lov om ændring af lov om lægemidler og lov om apoteksvirksomhed nr. 382 af 28. maj 2003").
- SUSARs arising from clinical trials in Denmark whose conduct have been authorised by the Danish Health and Medicines Authority must be reported to the Danish Health and Medicines Authority.
- SUSARs arising from clinical trials with the same protocol (same EudraCT number) in other EU countries must also be reported to the Danish Health and Medicines Authority.
You can read more about the EU Commission's clinical trials guidelines in EudraLex - Volume 10 (see link in the right-hand box).
In the following, we provide information on the reporting of adverse reactions in clinical trials for commercial sponsors and non-commercial sponsors, respectively. Furthermore, the tables below provide information for both commercial sponsors and non-commercial sponsors on the reporting of adverse reactions in clinical trials.
Please be aware that there are special rules for the reporting of adverse reactions in clinical trials notified before 1 May 2004 and for the reporting of adverse reactions in clinical trials in animals.
Reporting of adverse reactions in clinical trials for non-commercial sponsors
The Danish Health and Medicines Authority's recommends non-commercial sponsors to report adverse reactions using the e-form for the "Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials", which is available in the box to the right.
Alternatively, the CIOMS form can be used. Please remember to include the EudraCT number and the Danish Health and Medicines Authority's case number. The CIOMS form can be found in Annex 9 of the "Guideline for applications for authorisation of clinical trials of medicinal products in humans" (see box to the right).
Serious adverse reactions arising in "non-interventional trials" must be reported spontaneously as these trials are not regulated by the clinical trials regulation.
Reporting of adverse reactions in clinical trials for commercial sponsors
Commercial sponsors are encouraged to report SUSARs electronically when it concerns clinical trials in Denmark. Electronic reporting is possible either via EudraVigilance or via the Danish Health and Medicines Authority's e-form.
For more details, please see 'Electronic reporting of adverse reactions via EudraVigilance' below.
Commercial sponsors who do not have access to EudraVigilance can use the e-form for "Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials" to report SUSARs occurring in Denmark. The e-form is accessible in the box to the right.
SUSARs arising from clinical trials with the same EudraCT number in other EU countries can be reported electronically, either via EudraVigilance or via the Danish Health and Medicines Authority's e-form.
Electronic reporting of adverse reactions via EudraVigilance
SUSARs occurring in clinical trials conducted in Denmark can be reported electronically to the Danish Health and Medicines Authority via a Clinical Trial Module to the larger EudraVigilance database of the European Medicines Agency (EMA) in London. Please read the announcement "Electronic reporting of adverse reactions from clinical trials in humans" in the top right-hand box.
In order to be able to report SUSARs electronically to EudraVigilance, sponsors must be registered in the system and have tested the connection with EMA and the Danish Health and Medicines Authority. See the link to EudraVigilance as well as the "Procedure for testing exchange of E2B files with the Danish Health and Medicines Authority" in the right-hand box.
SUSARs submitted to the Clinical Trials Department at the Danish Health and Medicines Authority are transmitted via the EudraVigilance Gateway. The Danish Health and Medicines Authority's ID concerning SUSARs is DKMAEUDRA. SUSARs must be sent electronically in E2B format.
Handling of adverse drug reactions from clinical trials
In accordance with GVP Module VI - Management and reporting of adverse reactions to medicinal products section VI.C.1, VI.C.6.2.1.2 and VI.C.6.2.3.7.
Suspected adverse reactions should not be reported under both regimes, that is Directive 2001/20/EC as well as Regulation (EC) No 726/2004 and Directive 2001/83/EC as this creates duplicate reports.
Only cases of Suspected Unexpected Serious Adverse Reactions (SUSARs), related to investigational medicinal products studied in clinical trials which fall under the scope of Directive 2001/20/EC, should be reported by the sponsor to the EudraVigilance Clinical Trial Module (EVCTM).
For clinical trial conducted in accordance with Directive 2001/20/EC and where the adverse reaction is only suspected to be related to a non-investigational medicinal product (or another medicinal product which is not subject to the scope of the clinical trial) and there is no interaction with the investigational medicinal product: the report should be considered as spontaneous report and should be reported to the EudraVigilance Post-Authorisation Module (EVPM).
Guidance for reporting adverse reactions in clinical trials for commercial and non-commercial sponsors
|
Observed in Denmark |
Observed outside Denmark |
Adverse reactions/
incidents |
Must appear from the final report on trial results submitted to the Danish Health and Medicines Authority. |
Must appear from updates of the documentation when new trials are notified. |
Expected, serious and suspected adverse reactions |
Must appear from the list to be submitted annually together with a report on the safety of trial subjects of the trial concerned. |
Must appear from the list to be submitted annually together with a report on the safety of trial subjects of the trial concerned. |
Suspected unexpected serious adverse reactions (SUSARs) |
Must be reported immediately by the sponsor.
(Please note that serious adverse reactions/events which are assessed to have no causal relationship with the medicinal product and which are expected are not subject to this reporting obligation.) |
Must be reported immediately by the sponsor if the SUSAR has occurred in a trial with the same EudraCT number/protocol in another EU/EEA country.
SUSARs occurring in other trials and third countries must only be reported if they may affect ongoing trials in Denmark, in which case a protocol amendment must be forwarded. |
Reporting of adverse reactions in clinical trials in humans notified before 1 May 2004
In regard to clinical trials notified before 1 May 2004, the investigator is obliged to report serious adverse reactions and adverse events to the Danish Health and Medicines Authority immediately.
You can find more information in the 'Guideline on notification of clinical trials of medicinal products in humans (for trials notified before 1 May 2004)' (see at the top of the box to the right). This guideline also contains the table below. The form for reporting adverse reactions in clinical trials notified before 1 May 2004 is also available to the right, but is in Danish only.
Guidance for reporting adverse events and adverse reactions in clinical trials notified before 1 May 2004.
|
Observed in Denmark |
Observed outside Denmark |
Adverse events and adverse reactions |
Must appear from the final report on trial results submitted to the Danish Health and Medicines Authority. |
Must appear from updates of the documentation when new trials are notified. |
Adverse events and adverse reactions |
Must be reported immediately by the responsible investigator. The report must be accompanied by comments on any consequences for the concerned trial.
Serious adverse events assessed by the investigator to have no causal relationship with the subjects' participation in the trial are not subject to this reporting obligation. |
Are subject to national legislation, and if the company/investigator considers that they may impact ongoing trials in Denmark, they must immediately be reported to the Danish Health and Medicines Authority, in which case a protocol amendment must be forwarded. |
Reporting adverse reactions in clinical trials in animals
The investigator is obliged to immediately report serious adverse reactions and adverse events occurring in veterinary trials to the Danish Health and Medicines Authority.
You can find more information in the 'Guidelines on application for clinical trials of veterinary medicinal products in animals" from March 2010 (see link at the top of the right-hand box). The form for reporting adverse reactions in clinical trials of veterinary medicinal products in animals can be found in Annex 5.
