Regulatory Focus™ > News Articles > EMA Adopts Reflection Paper on Evaluating Clinical Trial Samples

EMA Adopts Reflection Paper on Evaluating Clinical Trial Samples

Posted 20 March 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) adopted a reflection paper that aims to provide quality systems guidance for laboratories in charge of analyzing and evaluating samples generated from clinical trials.

Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, adopted 28 February and released 20 March, intends to provide clinical laboratories "with information that will help them develop and maintain quality systems" that comply with EU regulations and the expectations of national monitoring authorities.

"There are some aspects of Good Lab Practices (GLP) that will be applicable to clinical sample analysis," writes EMA. "However, it should be noted that the scope of GLP is designed for non-clinical studies and consequently does not take into account issues that may impact on the safety and rights of clinical trial subjects.

The guidance covers:

  • organization of a lab and its responsibilities
  • duties of personnel
  • contracts and agreements
  • clinical trial conduct
  • requests for additional work
  • subcontracting out laboratory analysis
  • patient and subject safety safeguards
  • informed consent
  • handling and storage of samples
  • method validation
  • repeat analysis
  • data recording
  • reporting
  • facility specifications
  • maintenance of equipment
  • computerized systems
  • quality assurance processes
  • quality control processes
  • standard operating procedures
  • blinding and un-blinding procedures
  • retention of data
  • preparation and distribution of clinical kits


Read more:

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

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