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The clinical trial regulations (EU-CTR) ensure that the rights, safety, dignity and well-being of subjects are protected and data generated during clinical trials are robust and reliable. [2] The regulation aims to harmonize the processes for assessment and oversight of clinical trials throughout the EU.
CPMP/EWP/1776/99: Missing data in confirmatory clinical trials [21] (EMA) explains how the presence of missing data in confirmatory clinical trials should be addressed and reported in a dossier submitted for regulatory review. It provides an insight into the regulatory standards that will be used to assess confirmatory clinical trials with ...
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Volume 2C deals with Guidelines. Volume 3 - Guidelines. Concerning Medicinal Products for human use in clinical trials (investigational medicinal products). Volume 10 - Clinical trials. Concerning Veterinary Medicinal Products: Volume 5 - Pharmaceutical Legislation. Volume 6 - Notice to Applicants. Volume 7 - Guidelines. Volume 8 - Maximum ...
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
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