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Filling out the Ctis Online Filling Form can be straightforward if you follow the provided guidance. This step-by-step guide will help you understand each section of the form and how to complete it effectively.
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- Press the ‘Get Form’ button to download the Ctis Online Filling Form and open it in your preferred editor.
- Begin by filling in the personal information section. Input your full name, contact details, and address accurately.
- In the subsequent section, provide any required identification numbers or account information as specified.
- Next, complete the eligibility criteria fields by selecting the appropriate answers based on your circumstances.
- Continue to the documentation upload section. Attach any necessary files requested by the form, ensuring that they meet the specified formats.
- Review all the information you’ve entered for accuracy. Make sure there are no typographical errors or missing information.
- Once you are satisfied with the form, you can save changes, download a copy for your records, or print it out for submission.
- Finally, submit the form according to the provided instructions, either through electronic submission or physical mailing, depending on requirements.
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EU-CTD obliges multiple safety submissions to NCAs and ECs, whereas EU-CTR requires all safety reporting via EudraVigilance. A single safety report can be submitted for trials involving more than one IMP, but all unexpected events which affect a trial's benefit-risk balance must be reported within 15 days.
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