EN PL

EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

10.05.2012
The purpose of this reflection paperi is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help them develop and maintain quality systems which will comply with relevant European Union Directives, national regulations and associated guidance documents. It will also provide information on the expectations of the inspectors who may be assigned by national monitoring authorities to inspect facilities that perform work in support of human clinical trials.