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Home / Non-interventional post-authorisation studies... / Non-interventional post-authorisation study...

Non-interventional post-authorisation studies notification form

Items marked with * are mandatory and have to be completed.

Information on the medicinal product

SÚKL code:

For studies covering more medicinal products use the button repeatedly

Study

Information on the study

Type of study: *

Marketing post-authorisation study
Post-authorisation safety study (PASS)

Performed voluntarily by MAH
Imposed by SUKL
Imposed by other regulatory authority (e.g. EMA)

Post-authorisation efficacy study (PAES)
Other type of study

Study title: *

Study ID according to MAH's documents: *

Objectives of the study: *

Up to 500 chars including spaces and separators

Further characteristics (study description): *

Further characteristics: *

Case study
Case series study
Cross-sectional study (survey)
Cohort study
Case-control study
Retrospective study
Database analysis
Patients register

Dates

Start of data collection: *

End of data collection: *

End of data analysis: *

Expected date of final report submission: *

Date of protocol approval (only for imposed studies):

Documents related to the study

Study protocol:

Other related documents:

Attachmnet:

Comment

Information on person responsible for the study

MAH / CRO / Organization performing the study: *

First name: *

Last name: *

Telephone contact: * (uveďte pouze jedno telefonní číslo)

Email contact: *

Please note

Po kliknutí na "Odeslat" se Vámi vyplněné údaje zanesou do databáze a zobrazí se nová stránka "Potvrzení o přijetí údajů k neintervenční poregistrační studii". Na této stránce budou uvedeny potřebné údaje týkající se Vašeho hlášení a dále je zde vygenerováno identifikační číslo a heslo, které později použijete pro Hlášení ukončení studie.

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