Compile the file
The following documents are mandatory for a valid submission:
- A sworn statement from the physician that the informed consent was obtained in accordance with the law of 22 August 2002 on patient rights
- Information and consent form (see ICF template)
- The motivation that without appropriate treatment, it is expected that the patient's death occurs in a short delay or that the risk for the consequences of the absence of treatment is greater than the risk for the consequences of starting the treatment is included.
If relevant for your study, the following can also be submitted: :
Prepare the file
Only one file per component can be uploaded.
Do you have several files per component? Group them in a compressed folder (zip-file).
When you start your application, you need to complete the whole process. Youu cannot save in the meantime.
Do you have all the documents?