Soms verlopen de Haagse zaken voorspoediger dan verwacht. Op 11 september 2015 sprak ik op het 4e symposium ‘Update Regelgeving bij Klinisch Onderzoek’ van de...
Naast cijfers over het aantal medisch-wetenschappelijke onderzoeken dat in Nederland jaarlijks wordt beoordeeld (zie ‘Medisch wetenschappelijk onderzoek met mensen in Nederland in de periode 2001 tot en...
“Thousands of clinical trials have not reported their results; some have not even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. The contributions of the hundreds of thousands of patients who took part in those trials remain unused and unusable. All trials past and present should be registered, and the full methods and the results reported.” (AllTrials, 2014)
De CGR heeft besloten om het ‘Toetsingskader niet-WMO-plichtig onderzoek’ per 1 januari 2015 over te nemen. Inmiddels is er een webpagina in de lucht...
Kaderreglement Biobanking UMC Utrecht, Versie 19 juni 2013 http://www.umcutrecht.nl/subsite/biobank/Informatie/Kaderreglement-Biobanken.htm (Featured image: “Cell Culture” door Umberto Salvagnin (http://www.flickr.com/photos/kaibara/3075268200/) [CC-BY-2.0], via Wikimedia Commons)
Well, professor Williams, that's exactly why we have an Ethics Committee! pic.twitter.com/ccgT8nmTw6 — Lego ResAdm (@LegoResAdm) August 15, 2014
Ethical review, according to the ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects ‘ (CIOMS, 2002): Ethical review. The ethical review committee is...
European Medicines Agency – – Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of...