
H Competent Authority EudraCT Application Page Help Form
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People also ask
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How do I upload results to EudraCT?
Once logged in 'your page', select the relevant trial and click on 'Edit': 2. Afterwards, click on 'post results' at the top right corner of the trial's page: 3.
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When should EudraCT number be applied for?
A EudraCT number is required in order to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) and to apply for Research Ethics Committee (REC) approval for your study.
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What replaced the EudraCT?
No new EudraCT numbers are issued since February 2023. They have been replaced by EU CT numbers.
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What is the difference between EudraCT and EU CT number?
The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. SUSAR reports). No new EudraCT numbers are issued since February 2023. They have been replaced by EU CT numbers.
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Will CTIS replace EudraCT?
Sponsors of EU/EEA EudraCT trials that are expected to continue after 30 January 2025 are required to transition those trials to the CTIS at their earliest convenience. It's important to be aware that the timeframe for the Member State(s) procedure, which can take up to 3 months, is part of the provided deadline.
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Is CTIS replacing EudraCT?
Sponsors of EU/EEA EudraCT trials that are expected to continue after 30 January 2025 are required to transition those trials to the CTIS at their earliest convenience. It's important to be aware that the timeframe for the Member State(s) procedure, which can take up to 3 months, is part of the provided deadline.
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How to post results on EudraCT?
Post results Once logged in 'your page', select the relevant trial and click on 'Edit': 2. Afterwards, click on 'post results' at the top right corner of the trial's page: 3.
-
When should EudraCT number be applied for?
A EudraCT number is required in order to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) and to apply for Research Ethics Committee (REC) approval for your study.
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