1. When did the mandatory notification requirement for non-interventional studies (NIS) enter into effect?
The beginning of a non-interventional study within the meaning of Art 8 of the Ordinance of the Federal Minister of Health on the Notification Requirement for Non-Interventional Studies (Verordnung des Bundesministers für Gesundheit über die Meldepflicht von Nicht-interventionellen Studien) is defined as the day the first patient is enrolled into the study.
The Ordinance does not apply to patients enrolled into a non-interventional study before 1-Sep-2010. It does, however, apply to patients included on or after 1-Sep-2010. In these cases, therefore, the non-interventional study has to be notified to the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG), and the study has to comply with the requirements set out in the Ordinance and the corresponding guidance document.
2. Can I notify the authorities of an ongoing NIS?
Non-interventional studies having included patients before 1-Sep-2010 do not have to be reported retroactively. See Question 1, ‘When did the mandatory notification requirement for non-interventional studies (NIS) enter into effect?’
Technically, however, retroactive notifications are possible.
3. Are any fees payable when submitting a NIS notification?
The Notification of a NIS is allocated with a fee by the BASG according to the Schedule of Fees (Gebührentarif) pursuant to the Austrian Food and Health Safety Act (Gesundheits- und Ernährungssicherheitsgesetz).
4. Do patients have to be provided with the proprietary medicinal product free of charge?
No, this is not a legal requirement.
5. The Ordinance uses the term ‘authorisation’ (Zulassung). Do the provisions of the Ordinance also apply to medicinal products registered in accordance with the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG)?
The term "Zulassung" (‘authorisation’) as used in the ordinance should be interpreted more comprehensively, and the provisions of the Ordinance of the Federal Minister of Health on the Notification Requirement for Non-Interventional Studies therefore also apply to medicinal products registered in accordance with the AMG. Specifically, this applies to registered homeopathic medicinal products, registered traditional herbal medicinal products, and registered pharmacy-proprietary medicinal products.
6. What is the NIS notification number (NIS-Meldenummer)?
The NIS notification number (NIS-Meldenummer) serves the purpose of unequivocally identifying a non-interventional study in the electronic NIS notification system of the BASG (currently only available in German). Every non-interventional study is assigned a unique notification number that cannot be changed.
After a NIS has been successfully reported using the Neue NIS melden (‘Report new NIS’) function, the NIS notification number and the accompanying password are sent by email to the person responsible for the study and, if applicable, to the person submitting the NIS notification.
7. Can I change the password assigned to a specific NIS notification number?
The transmitted password itself cannot be changed.
However, if you wish to deactivate the password and replace it with a new one, you can request a new automatically generated password. You can submit your request via the electronic NIS notification system. See Question 8, ‘How do I request a new password?’.
Please note that the new password can be transmitted only by email to the person responsible for the NIS and the person submitting the NIS notification.
Both of these email addresses are part of the NIS notification and will be taken over from the data entered during the online notification process. If these email addresses have changed since you first reported the non-interventional study and you have not yet updated them in the electronic notification system, please write an email to nisagesat.
In case you forget the NIS notification number or password, please write an email to nisagesat.
8. How do I request a new password?
When selecting the "Vorhandene NIS bearbeiten" (‘Update NIS data’) function, the log-in window opens.
You can request a new password by pressing the Neues Passwort generieren (‘Generate new password’) button.
You then have to enter the NIS notification number and an email address. The email you enter has to be either that of the person submitting the NIS notification or the person responsible for the NIS.
A new password will not be generated until the email address you entered has been successfully verified. Once a new password has been generated, it will be sent to the email address of the person responsible for the NIS and, if applicable, to the notifying person.
9. Who are the ‘person responsible for the NIS’ and the ‘person submitting the NIS notification’?
The person responsible for the NIS (Verantwortlicher) is the person in whose name the non-interventional study will be conducted. The contact data and affiliation of this person are visible in the publically accessible registry.
The person submitting the NIS notification (Studienmelder) is the person who functions as contact for the non-interventional study and who enters the data on behalf of the person responsible for the NIS.
Because the person responsible for the NIS and the person submitting the NIS notification may be identical, the field for the person responsible for the NIS is automatically filled with the data entered in the field for the person submitting the NIS notification. However, you are free to overwrite this suggestion. Also, you can enter two different email addresses even when the person responsible for the NIS is identical with the person submitting the NIS notification.
10. Which data and documents do I need to first report a NIS?
Name, address, and email address of the person responsible for the NIS
Name, address, and email address of the person submitting the NIS notification, if applicable
Information on the design and background of the NIS:
- Is the NIS multinational?
- Is the NIS a post-marketing commitment required by regulatory authorities?
- Is the NIS a commercial or an academic study?
- Will the patients be informed about their participation in the NIS?
- Planned number of patients to be enrolled
- mean total fee per physician per patient
- Planned treatment start in Austria
- Planned end of the study. For national studies, the date the study is expected to end in Austria should be given. For multinational studies, the expected global study end should be given.
- Is the statement of an Austrian lead ethics committee available?
- Name and address of the physicians, dentists, pharmacies, or hospitals who are expected to participate in the NIS
When first reporting the non-interventional study, the following documents must be uploaded in PDF format:
- NIS observation and evaluation plan
- NIS contract template/statement
- Positive/negative statement of the lead ethics committee, if available.
11. What are the IT requirements for using the electronic NIS notification system?
Hardware requirements for use of the NIS notification system:
- Computer (e.g., PC, notebook) with internet access
- Screen resolution: The optimal screen resolution is 1024 x 768 pixel and 256-colour mode or higher.
- Internet access: ISDN/ADSL access or dial-in access: An ISDN/ADSL access requires an ISDN/ADSL connection, including any equipment that may be needed. Dial-in access only requires a telephone connection, a modem, and the accompanying modem driver software. The best response times are obtained with high-speed internet access (e.g., ADSL).
Software requirements for use of the NIS notification system:
- Operating system: No specific operating system is required.
- Web browser: For best results, always use the latest browser version available for download from the website of the respective browser manufacturer.
- Additional software is not required. To display PDF documents, Adobe® Reader is required, which can be downloaded free of charge from the internet.
12. Can I enter umlauts in the electronic form?
In the electronic form, umlauts are accepted. However, umlauts cannot be used in email addresses.
13. How do I upload a document?
- To start the upload process, select the type of document you wish to upload from the predefined list (NIS observation and evaluation plan, NIS contract template/statement, statement of the lead ethics committee).
- From the window that opens, click the Durchsuchen… (‘Browse…’) button to select the file you wish to upload.
- To confirm your selection, click the Eingabe hinzufügen (‘Add selection’) button. The document will be added to the list of documents.
- The maximum files size for PDF uploads to the electronic NIS notification system is 10 MB.
- Please note that every document type may only be uploaded once per NIS. Therefore, please be sure to combine multiple documents belonging to the same document type into one single PDF file before uploading.
- To upload *.xml files, proceed as described above without, however, selecting a document type.
14. How do I navigate back and forth between pages of the electronic form?
Please be sure to always use the Zurück (‘Previous’) and Weiter (‘Next’) buttons in the form. Do not use the ‘Back’ and ‘Forward’ buttons of your browser.
15. What does the error message Es ist bereits ein Benutzer für diese NIS angemeldet. (‘Another user is logged into this NIS.’) mean?
This error message may be displayed for one of two reasons. Either (1) another user is currently logged in using your password and the NIS notification number (e.g., the responsible or notifying person) or (2) you left the website without having logged out from the electronic NIS notification system using the ‘Logout’ button and your previous session is therefore still open. In case you closed the browser without first having clicked the ‘Logout’ button, you have to wait for a timeout of 30 minutes before you can log into the system again.
16. Why does the system not accept the marketing authorisation number of the proprietary medicinal product?
Only medicinal products authorised/registered in Austria may be used in non-interventional studies. This concept is inherent in the definition of ‘non-interventional study’. Please check the Austrian Registry of Proprietary Medicinal Products (Arzneispezialitätenregister), which is publically accessible on the BASG/AGES website, to find out whether a particular medicinal product is authorised/registered in Austria.
If the product in question is currently authorised/registered in Austria, please check whether the marketing authorisation number you entered contains any spaces. Delete those before trying to re-enter the number. When entering an EU marketing authorisation number, make sure you enter the predefined 15 characters.
17. What is the Austrian Registry of Proprietary Medicinal Products (Arzneispezialitätenregister) and how can it be accessed?
The Austrian Registry of Proprietary Medicinal Products allows you to search for all proprietary medicinal products authorised/registered in Austria.
It can be accessed from the website of BASG under www.basg.gv.at.
18. What is the Reimbursement Codex (Erstattungskodex) and how can I access it?
In accordance with Art 31 of the Austrian General Social Insurance Act (Allgemeines Sozialversicherungsgesetz, ASVG), the Association of Austrian Social Insurance Institutions (Hauptverband der österreichischen Sozialversicherungsträger) is obliged to publish a Reimbursement Codex for proprietary medicinal products dispensed by office-based physicians at the expense and for account of an insurance institution. The Codex contains proprietary medicinal products that are authorised, reimbursable, and guaranteed to be in stock in Austria.
The Reimbursement Codex can be accessed via the following link: http://www.basg.at/links/
21. Does a patient insurance have to be concluded for a non-interventional study?
A study-related patient insurance is not required by law.
22. What is the ‘mean total fee per physician per patient’?
The ‘mean total fee per physician per patient’ includes any monetary or non-monetary payments.
23. The Ordinance uses the term ‘ethics committee.’ Why, then, is the statement of a lead ethics committee required?
The Ordinance says ‘an ethics committee in accordance with Art 41b of the Medicinal Products Act’ („eine Ethikkommission gemäß § 41b Arzneimittelgesetz“). Art 41b deals with the special demands in terms of ethics committees officially recognised by the Ministry of Health as being entitled to issue opinions for multicentre clinical studies and refers exclusively to lead ethics committees.
25. If the statement of a lead ethics committee is sought, do local ethics committees also have to be informed of the study?
No, in analogy to clinical studies, local ethics committees do not have to be informed of non-interventional studies.
26. Can the statement of the lead ethics committee of another country participating in a multinational NIS be used when submitting a NIS notification?
No, when first submitting a NIS notification, only statements by Austrian lead ethics committees will be considered relevant in terms of applicable deadlines. Submitting a statement by an ethics committee from another country is of no legal relevance.
27. In case the statement issued by a lead ethics committee has a limited period of validity, do we have to submit a new statement after the period of validity has expired?
No, this is not legally required. The statement issued by the lead ethics committee is mainly used to determine the point in time when a reported non-interventional study may commence.
28. Is a contract template invariably required?
In the electronic NIS notification system, submission of a contract template is a mandatory field. If the person responsible for the study is the only person actually performing the study, no contract template is needed. In this case, however, a written statement to this effect should be uploaded instead of the contract template.
29. How is the end of a NIS defined?
The end of a NIS is defined as the point in time when the last data obtained are submitted for analysis.
30. When do the final report and the abstract of the final report have to be submitted? Are there any exceptions?
Art 7 para 1 of the Ordinance requires the person responsible for the NIS to electronically submit a final report and an abstract thereof to BASG within a maximum of 12 months after conclusion of the study,. The abstract of the final report will then immediately be published in the public registry.
Twelve months after the reported end of the study (for national studies, the reported end of the study in Austria; for multinational studies the reported international end of the study), the electronic NIS notification system will send an automated reminder for the final report and abstract to be submitted. In case no study end has been entered, the system uses the planned study end specified when the NIS was first entered into the system.
In case of delays, please send a reasoned statement to nisagesat, specifying the estimated length of the delay.
The system is currently being updated to enable the entry of the expected delay directly into the system.
32. Which of the data contained in the registry are publically accessible?
Pursuant to the Ordinance of the Federal Minister of Health on the Notification Obligation for Non-Interventional Studies, the following data will be published in the registry:
- Name and address of the person responsible for the study
- Name(s) of the proprietary medicinal product(s): lists of proprietary medicinal products will be comma-separated
- Planned study duration: planned beginning and end (For national studies, the date the study is expected to end in Austria should be given. For multinational studies, the expected global study end should be given.)
- Planned regions by political district
- Planned number of participating patients
- NIS status (active, discontinued, finished, completed)
- If the NIS was discontinued, the reason for discontinuation can be added at the request of the person responsible for the study. In this case, enter ja (‘yes’) in the Soll die Begründung des Abbruchs veröffentlicht werden? (‘Do you wish the reason for discontinuation to be published?’) field.
- Abstract of the final report (*.pdf document)
- BASG comments, if applicable
33. Wie generiere ich xml-Files für den Upload von Teilnehmern?
Created: 12.08.2010 | Page last modified: 12.12.2012