EMA: Regulatory and procedural guideline: Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples

The purpose of this guidance document is to provide laboratories that perform the analysis of 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.