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H Competent Authority EudraCT Application Page Help Form
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People also ask
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What is the date of Competent Authority decision?
Date of Competent Authority Decision This is the date on which the National Competent Authority Decision was made on clinical trial. Date of Ethics Committee Opinion This is the date on which the Independent Ethics Committee Opinion was given on clinical trial.
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Is EudraCT mandatory?
Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) is mandatory.
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What is the start date of a clinical trial?
The start date is the actual date on which the first participant was enrolled in a clinical trial. The “estimated” start date is the date that the researchers think the trial will start. Understanding a clinical trial listing merckclinicaltrials.com https://.merckclinicaltrials.com › how-to-read merckclinicaltrials.com https://.merckclinicaltrials.com › how-to-read
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How do I upload results to 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.
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What is the difference between EU CT and EU CTR?
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. Understanding the new EU Clinical Trial Regulation europeanpharmaceuticalreview.com https://.europeanpharmaceuticalreview.com › article europeanpharmaceuticalreview.com https://.europeanpharmaceuticalreview.com › article
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What is Competent Authority in clinical trials?
All trials of unlicensed medicinal products or licensed medicines are likely to be subject to “Competent Authority” approval in most jurisdictions. The competent authority is typically the medicines regulator.
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What is the Competent Authority in clinical trials?
The competent authority is typically the medicines regulator. For trials conducted in only one country, regulatory approval is only required in the country where the trial is to be conducted. For international trials, approval by the national competent authority in each participating country is required. Regulatory approval - International Society of Nephrology theisn.org https://.theisn.org › research › isn-act-toolkit › regul... theisn.org https://.theisn.org › research › isn-act-toolkit › regul...
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What does EU CTR stand for?
This document provides answers to the most frequently asked questions received on the EudraCT database and on its public interface, the European Clinical Trial Register (EU CTR). EudraCT & EU CTR Frequently asked questions EudraCT https://eudract.ema.europa.eu › docs › guidance EudraCT https://eudract.ema.europa.eu › docs › guidance PDF
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