172x Filetype PPTX File size 0.37 MB Source: toolbox.eupati.eu
Clinical Study Report (CSR) European Patients’ Academy on Therapeutic Innovation The trial sponsor compiles a detailed clinical study report (CSR) after each clinical trial. This report follows a format laid down by the regulatory authorities. The CSR can be hundreds of pages long. Access to the complete CSR is usually limited to the sponsor and the regulatory authorities that are assessing the marketing authorisation application (MAA). 2 Public access to information from the CSR European Patients’ Academy on Therapeutic Innovation Information summarised from the CSR can be shared with the public through: European Public Assessment Reports (EPARs), Clinical trial registries, Marketing authorisation product information, Journal papers, Conferences, Patient organisation websites, and Popular news media. 3 European Public Assessment Reports (EPAR) European Patients’ Academy on Therapeutic Innovation When authorisation for a new medicine is sought via the Centralised Procedure (CP), an assessment report, an EPAR, is written by the European Medicines Agency (EMA). This report is published on the EMA website after a decision has been made either to approve or reject the authorisation application. The EPAR provides the public information on a medicine, including how it was assessed by the EMA committees. 4 European Public Assessment Reports (EPAR) European Patients’ Academy on Therapeutic Innovation Any information handled during the scientific assessment that is considered confidential is removed before the EPAR is published. The EPAR is intended for a professional audience and uses technical language. It is, however, accompanied by a summary, normally two or three pages long, which presents the key facts in non- technical language. 5 Clinical Trial Registries (Europe) European Patients’ Academy on Therapeutic Innovation The European Clinical Trials Database (EudraCT), www.clinicaltrialsregister.eu, of the European Medical Agency collects information on all clinical trials of medicines performed in Europe. From July 2014 this database also makes trial summary results available to the public. For trials taking place in the EU starting after 1st January 2015, all results must be published, both positive or negative. 6
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