Ich empfehle allen meinen Kolleginnen und Kollegen, zeitnah einen Blick auf die neue EU Clinical Trials Regulation für Medizinprodukte von 2014 (EU/536/2014) zu werfen.
I recently found a case study at the most interesting website crgcp.org dealing with serious breaches during a clinical trial, and the required action taken by the CRA. You may find this example at www.crgcp.org/content/2015/10/05/serious-breaches-case-study.
