The Danish Medicines Agency now launches an e-form in English for reporting suspected unexpected serious adverse reactions in clinical trials (SUSARs). The e-form specifically targets researchers and small and medium-sized enterprises that for some reason cannot report via EudraVigilance. The e-form is also available in an identical Danish version. Both versions have been simplified to facilitate reporting.
Required fields in the form
The form has a limited number of required fields.
In order for an adverse reaction to be a SUSAR, four criteria must be satisfied. This means that we must be given details about each of the following: The adverse reaction, the suspected medicine, the patient and the reporter’s name and workplace. These fields are therefore mandatory and marked with an * in the form. In addition, we need to know how the patient was affected by the adverse drug reaction (hospitalisation, disability, life-threatening condition, congenital malformation, death or other medically important event), and replies to these questions are therefore obligatory. Furthermore, we must be informed if it is the investigator or sponsor who is submitting the report, the name of the study, the EudraCT no. and country of origin, and we must know if the report is new (Initial) or whether it is a follow-up report on a previously reported SUSAR (Follow up).
It helps our further evaluation significantly when we are provided with as many details as possible about the course of events. Therefore, the form contains additional questions. Some of them are conditionally mandatory, e.g. if it has been indicated that the adverse drug reaction caused the patient to die, it is mandatory to answer whether an autopsy has been performed.
Features
Causality assessment
To ensure that only SUSARs are registered in the adverse drug reaction database, it is mandatory to indicate whether there is a causal relationship between the adverse reaction and the investigational medicinal product. Therefore, the form also contains a page for this purpose. On the page "Causality assessment", all combinations of the adverse reactions entered on page 2 and investigational medicinal products entered on page 3 are created. The assessment must be made by either the investigator or sponsor or by both. The causality must be indicated as either "Reasonable possibility" or "No reasonable possibility". It is only possible to submit a report if the causality of at least one drug-reaction combination is assessed as "Reasonable possibility".
If you need to change a causality assessment for a previously submitted SUSAR, you can send a Follow up as described earlier. In this case, remember to enter the relevant adverse reaction (page 2) and the relevant investigational medicinal product (page 3) in order for the causality assessment fields to unfold.
MedDRA terms
A feature of the form is the possibility to retrieve a specific term from an international medical dictionary to describe the adverse drug reaction, cause of death, indication and other diseases/conditions suffered by the patient. The dictionary is called MedDRA (Medical Dictionary for Regulatory Activities) and has some 60,000 English terms to choose from, allowing the reporter to select a term that best describes the concerned adverse drug reaction, symptom or diagnosis. A drop-down list of terms to choose from appears when you enter three letters in a field, and as you type more letters, the selection of terms becomes fewer. If you prefer not to use MedDRA, you can disable the feature as you please.
Look-up based on address
General practitioners in Denmark have the possibility of retrieving workplace details via their provider IDs. Moreover, hospital staff can retrieve details about workplace, department, telephone number, etc. via the department’s SKS code (Danish Healthcare Sector’s Classification System).
Layout
The design and layout of the form is simple. For example, the field 'autopsy' only appears if the reporter has indicated that the adverse drug reaction caused the patient to die.
Before you click submit, a summary of entries is provided allowing you to check that the entered information is correct. You can also print out this page.
Receipt
When you have submitted an adverse reaction report, you will no longer receive a receipt py ordinary post. You have the opportunity of providing an email address to receive a receipt via email. The email that you will receive contains a reference number to be used if the need arises to report follow-up information to the SUSAR. Should it become relevant, select "Follow up" on the first page instead of "Initial". You can also save the report as you go along. Simply click "Save", and you will be prompted to provide your email address. An auto-generated numeric code is also displayed. Use this code to retrieve the saved report at a later stage.
