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Data from one study site (including 10 randomized patients) were removed from the analysis datasets, as inadvertently a centrally approved informed consent form was used without the additional mandatory approval of the site's local ethics committee.
The database is available online for drugs centrally approved within the EU [ 15].
The EMA publishes the European Public Assessment Reports (EPARs) of all centrally approved or refused medicines on its website.
The Dutch LEMMoN study was centrally approved by the medical ethics committee of the Leiden University Medical Centre (ref P04-020).
A cross-sectional analysis was performed of all PSURs and PSUR assessment reports (PARs) created for biopharmaceuticals centrally approved in the EU since 1995.
In 2011 and 2012, 50 new drugs (excluding vaccines, combinations of known drugs, and extensions of indications) were centrally approved in Europe.
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Local policies could deny co-enrollment approved centrally.
The study protocol was approved centrally by the Ethical Review Board of Oxford University Oxford Tropical Research Ethics Committeee) and the ethics committees responsible for each hospital in China.
The diagnoses are approved centrally by the National Social Insurance Institute when applying for subsidies, which reduces heterogeneity in diagnostic practice.
The study protocol was approved centrally by the Ethical Review Board of Oxford University and the ethics committee in participating hospitals in China.
The GROUP study was approved centrally by the Ethical Review Board of the University Medical Center Utrecht and all participants gave written informed consent in accordance with the committee's guidelines.
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