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EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATEGENERALConsumer goods Pharmaceuticals Brussels,F2/ (2008)Revision 9Notice to ApplicantsMedicinal Products for Human Volume 2B Module 1: Administrative
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How to fill out eudract cz

01
Step 1: Access the EudraCT CZ website
02
Step 2: Register as a user by providing the required information
03
Step 3: Login with your registered credentials
04
Step 4: Select the 'Fill out EudraCT CZ' option from the menu
05
Step 5: Follow the on-screen instructions to provide the necessary details
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Step 6: Review the filled-out form for accuracy
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Step 7: Submit the form electronically
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Step 8: Wait for confirmation and further instructions from the EudraCT CZ authorities

Who needs eudract cz?

01
Researchers conducting clinical trials in the Czech Republic
02
Sponsors and coordinators of clinical trials
03
Ethics committees reviewing clinical trial applications
04
Regulatory authorities monitoring clinical trial activities

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EudraCT CZ is the national portal for submitting clinical trial applications in the Czech Republic.
Any sponsor or legal representative initiating a clinical trial in the Czech Republic is required to file EudraCT CZ application.
To fill out EudraCT CZ, sponsors should create an account on the portal, complete the required sections of the application form, and submit all necessary documentation.
The purpose of EudraCT CZ is to facilitate the submission and assessment of clinical trial applications in the Czech Republic, ensuring compliance with regulatory requirements.
EudraCT CZ requires information on the study protocol, study team members, investigational medicinal products, and other relevant details of the clinical trial.
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