USA: ClinRegs Website – Aggregating Clinical Research Regulations from Around the Globe (13-Nov-2014)

The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. By providing well-documented, up-to-date regulatory information for multiple countries in a single place, ClinRegs is intended to serve as a central resource and time-saver for persons […]

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EMA: Revision 1 of EMA GVP Module VI (03-11-2014)

The long awaited revision of EMA GVP Module VI (Management and reporting of adverse reactions to medicinal products) has been released and became effective on 16-SEP-2014. Revisions include: Revisions in VI.A.2.1.1. (Causality), VI.A.2.4. (Seriousness), VI.B.1.2. (Solicited reports), VI.B.3. (Follow-up of reports), VI.B.6.3. (Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure), VI.C.1. […]

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EMA: Reflection Paper on the Use of Patient Reported Outcome (PRO) Measures in Oncology Studies (01-SEP-2014)

The importance of the patient’s point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment effects. This reflection paper on the use of patient reported outcome (PRO) measures in patients with malignancies focuses on the value of these data from a […]

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Italy: New Platform for the “National Observatory on Clinical Trials of Medicines” (OsSC)(1-SEP-2014)

The National Monitoring Centre on Clinical Research with Medicines [Acknowledgements: Prof David Hutchinson. Principal Author & Editor of Advisor] [NOTE – The following does NOT apply to observational studies] The National Monitoring Centre on Clinical Research with Medicines (Osservatorio Nazionale sulla Sperimentazione Clinica con i Medicinali; OsSC) monitors ongoing clinical trials in Italy.  The Italian […]

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UK: NRES Website Closing Soon (14 Aug 2014)

The website of the National Research Ethics Service (NRES) site will be closing in a few weeks. The only areas that are maintained are the directory of Research Ethics Committees and the Research Summaries. The information previously found on the NRES website can now be found on the website of the Health Research Authority (HRA). […]

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