Transcript Folie 1

On-line NIS Registration System Austria
A practical Guide in English
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Entering the system: www.basg.at
1.
2.
3.
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Welcome Page
Edit existing NIS after having obtained password and NIS number
Register new NIS, e.g. request password and NIS number
Welcome
The following registry constritutes the practical translation of the „National Regulation
for the Reporting Obligations for Non-interventional Studies“, (Verordnung des
Bundesministers für Gesundheit über die Meldepflicht von Nicht-interventionellen
Studien), BGBl. II Nr. 180/2010.
The responsibility for safeguarding the NIS Reporting Number and the password and
the sharing of these details with third parties lies with the persons responsible for the
NIS. Liability of the Federal Office for Safety in Healthcare (Bundesamt für Sicherheit im
Gesundheitswesen, BASG) for any detriment resulting from the disclosure of access
information is precluded.
Should you have forgotten your password or should you want to deactivate and replace
an existing password, a new password can be requested in an automated fashion, as
long as the NIS number is known. The new password will be mailed to the e-mail(s)
associated in the system with the persons registering and responsible for the NIS
respectively.
Should the e-mails have changed in the meantime, or in case the NIS reporting number
and password have been replaced, please contact [email protected]
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Welcome page - Help
• Description of the functionalities of the NIS Registration System. Different functionalities are available depending on the NIS
registration status.
• Function „Neue NIS melden“ = Register new NIS
Choose this function to register a new NIS. Initially you are requested to enter contact information for the person registering
the NIS and the person responsible for the NIS. Once this information has been submitted by pressing the „send“ button, an
e-mail containing the NIS Registration number and matching password will be sent to the two e-mail addresses entered in the
system. Password and NIS registration number are required to enter further information with the function „vorhandene NIS
bearbeiten“
• Function „Vorhandene NIS bearbeiten“ = Edit existing NIS
Choose this function for data entry, updates and upload of documents. Please find in on the following slide a table listing the
possibilities for updates for the respective fields
• Function „NIS zurückziehen“ = Withdraw NIS
Choose this function to withdraw a NIS, which has been registered (without ethics vote), but is not yet visible in the public
registry (21 day silent approval time). A withdrawal requires the entry of a justification. A withdrawn NIS can not be restarted
at a later date, a new registration is required.
• Function „NIS abbrechen“ = Prematurely terminate NIS
This functionality is available only once the NIS is listed in the public registry, after successful registration and, where
applicable the expiry of the 21 day silent approval. The premature termination of a NIS requires the entry of a justification.
The applicant can choose to make the justification public or not, the termination will be visible in the public registry. A
terminated NIS can not be restarted at a later date, a new registration is required.
• Function „NIS beenden“ = End NIS
Choose this function to enter the date of the end for Austria (national NIS) or the global end of the NIS (multinational NIS).
Should you fail to enter a date in either one of these fields, the allotted time for submission of the final reports will be based
on the date initially entered upon registration for the „planned end of NIS“. The end of NIS will be visible in the public registry.
• Function „NIS Abschlussbericht“ = NIS Final Report(s)
Choose this function to upload the final report and the abbreviated final report for the NIS. The abbreviated final report will be
made available to the public and the NIS will be listed as finalized.
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Flexibility of Fields
Information Section
Flexibility
Substantial Amendment
Contact person registering
Modifiable until finalization (final report)
No
Contact person responsible
Modifiable until finalization
Yes
Medicinal product(s)
Not modifiable once submitted
-
NIS Definition
Not modifiable once submitted
-
Multinational NIS?
Modifiable until finalization
Yes
Postmarketing committment?
Not modifiable once submitted
-
Commercial or academic?
Not modifiable once submitted
-
Patient information on participation?
Not modifiable once submitted
-
Expected number of patients?
Modifiable until finalization
Yes
Total honorarium per participant per
patient?
Modifiable until finalization
Yes
Expected start in Austria?
Modifiable until finalization
Yes
Expected end in Austria?
Modifiable until finalization
Yes
Vote by an Austrian Lead-Ethics
committee?
Not modifiable, unless vote is requested
by the BASG
-
Expected number of participants
Modifiable until finalization
Yes
Files attached
Modifiable until finalization
Yes
NIS withdrawal
Not modifiable once submitted
-
NIS termination
Not modifiable once submitted
-
NIS end
Not modifiable once submitted
-
Final reports
Not modifiable once submitted
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NIS Content
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Field
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Screen 1:
Information on Person registering the NIS
Title
First name (*… required field)
Last name*
Organisation
Address*
Post code*
City*
State*
E-mail*
back
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continue
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Screen 2:
Information on Person responsible for the NIS
Title
First name* (*… required field)
Last name*
Organisation
Address*
Post code*
City*
State*
E-mail*
Note:
Fields will automatically be pre-filled with details of the person registering the NIS to facilitate data entry.
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On-line NIS Registration System
Confirmatory e-mail: NIS-Number and Password
Note:
This e-mail will automatically be sent to the two e-mail addresses entered on screen 1 and screen 2.
The „NIS-Meldenummer“ is the identifier of the Non-Interventional Trial when contacting the Agency.
The automatically generated password cannot be modified, however, a new password can be requested for an existing
NIS Number.
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Screen 3:
Step 1 information entry into the registration system
NIS number*
Password*
Enter
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Generate new password
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Screen 4 - NIS definition according to §2a Abs 3
Austrian Medicines Act (AMG)
Question 1: Are the medicinal products
used prescribed in the usual manner in
accordance with the terms of the
marketing authorisation? *
Question 2: Is the patient exposed to
additional diagnostic or therapeutic
measures beyond clinical routine? *
Question 3: Is the patient exposed to
any other additional measures? *
Question 4: Is an observation and
evaluation plan established? *
Question 5: Does the treatment reflect
the clinical routine? *
Yes
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No
Question 6: Is the decision to include
the patient in the NIS clearly separate
from the assignment to a particular
therapeutic strategy? Is the therapeutic
strategy decided prior to inclusion in the
NIS? *
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Additional Information
•
•
•
•
Help on fields on screen 3:
Definitions and Legal Framework
The Non-interventional Study is defined in § 2a para. 4 of the Austrian Medicinal Product Act. It represents the translation
of Art 2c of Directive 2001/20/EC into National law.
Art 2c DIR/2001/20/EC
‘non-interventional trial’: a study where the medicinal product(s) is (are) prescribed in the usual manner in
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•
§ 2a Para. 3 AMG:
„Nicht-interventionelle Studie“ ist eine systematische Untersuchung zugelassener Arzneispezialitäten an Patienten,
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•
accordance with the terms of the marketing authorisation.
The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but
falls within current practice and the prescription of the medicine is clearly separated from the decision to include
the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and
epidemiological methods shall be used for the analysis of collected data;
sofern
die Arzneispezialität ausschließlich unter den in der Zulassung genannten Bedingungen verwendet wird,
die nicht-interventionelle Studie keine zusätzlichen diagnostischen oder therapeutischen Maßnahmen notwendig
macht und keine zusätzlichen Belastungen des Patienten mit sich bringt,
und die Anwendung einer bestimmten Behandlungsstrategie nicht im Voraus in einem Prüfplan festgelegt wird, sie
der medizinischen Praxis entspricht und die Entscheidung zur Verordnung der Arzneispezialität klar von der
Entscheidung getrennt ist, einen Patienten in die Studie einzubeziehen.
Zur Analyse der gesammelten Daten werden epidemiologische Methoden angewendet. Nicht-interventionelle
Studien sind entsprechend dem Stand der Wissenschaften zu planen und durchzuführen.
The requirement to use the prescribed medicinal product(s) in accordance with the terms of the marketing authorisation
implies that its/their use is bound to the conditions of use outlined in the Summary of Product Characteristics (i.e.
indication and contra-indications, dosing, mode of application,..).
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Screen 5:
Entry of Medicinal Products
authorisation number
Medicinal products according to
§ 89 AMG
Are the medicinal products found in the codex
of reimbursement according to § 31 3 Z 12
ASVG (Act on General Procedures)
Add entry
Empty list
Marketing
authorisation
number
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Back
continue
Marketing
authorisation
holder
Tradename
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cancel
Codex of
Reimbursement
Additional Information
• Help on fields on screen 4:
• The authorization number entered is checked against the list of national and European authorized products by the
system.
• Medicinal Products according to § 89 AMG: A transitional period is in place for medicinal products which were on the
Austrian market on april 1st 1984 but not under a licensing obligation. Some of these products do not have an
authorization number and can therefore only be entered via the list provided.
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Screen 6:
Entry of further information
Yes
No
Multinational NIS? *
Is this NIS part of a post-marketing
committment? *
Commercial or academic
(non-commercial) NIS? *
Estimated number of patients *
Average total honorarium per patient *
Planned start date for Austria *
Planned end of NIS *
Opinion by an Austrian Lead-ethics committee? *
Pos
[email protected]
Neg
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None
On-line NIS Registration System – Errormessages
Error, please correct fields (red !)
No entry in Required field
Value entered not acceptable
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Screen 6:
Entry of participants
Add MD
Add dentist
Add hospital
Upload xml – see
following slides
Empty list
Back
Add pharmacist
continue
cancel
Note:
Upon entering a post-code, city/village names will be prefilled. In certain cases, a further
selection for political districts needs to be made. Please contact the agency when encountering
difficulties
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Screen 6:
Upload of participants via xml File
See: http://www.basg.at/arzneimittel/faq/nicht-interventionelle-studien/#c5762
Note:
The upload of a structured xml file for participants can be
performed via an XML-file and is practicable for NIS with
a large number of participants.
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Screen 6:
Upload of PDF documents
Contract template / Justification
Ethics opinion
Observation and evaluation plan
Add entry
Note:
Pdf-Dokuments are limited to 10 MB.
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Screen 6:
Update/delete PDF documents
Contract
template
Select
Observation and
evaluation plan
Delete
EC opinion (if
“yes” earlier)
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Screen 7:
Review and submission
• The information entered will be displayed on Screen 7 for review
• Information will be submitted by clicking the button „send“
• Confirmation of submission will be sent to the two addresses listed in the
information package,
• ..including the PDF of the submitted information
• ..in the form of an e-mail with attachment (see next slide)
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On-line NIS Registration System
Confirmatory e-mail
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On-line NIS Registration System – End NIS
Prematurely terminate NIS
End NIS
End in Austria (national NIS)
Global end (multi-national NIS)
Final reports already available? “x” for “yes”
Note: The date of the end of NIS corresponds to either the end in Austria (for Austrian Studies) and
the global end for multinational NIS. The timeline for submission of the final report and the abbreviated
final report starts with the date entered. The end of NIS is notified in the public registry.
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On-line NIS Registration System –
Upload final reports
End in Austria (national NIS)
Global end (multi national NIS)
NIS abbreviated final report
NIS final report
NIS final report
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NIS - Premature termination
NIS premature
termination
NIS premature termination
Justification
Text to be made public? If
yes, then „x“
Note:
Premature termination is possible for all NIS published in the registry. A justification for the termination is
required, but it is the applicant‘s choice of whether this text is made public. The status of premature
termination is visible to the public. Once terminated, a later restart of the NIS is not possible.
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NIS - Withdrawal
NIS
Withdrawal
Justification
Note:
Applicable only to NIS, which have been notified, but are not yet visible in the public registry. A
justification for the termination is required. Once withdrawn, a later restart of the NIS is not possible.
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NIS Public Registry
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How to enter the public NIS Registry
1.
2.
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3.
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NIS-Registry - Overview
Note:
The publicly available information can be downloaded as csv- or pdf-document.
Information can be sorted via the column headers (Organisation, person responsible, duration, status)
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NIS-Registry – Detail view
Abbreviated final report
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