Regulatory Focus™ > News Articles > EMA Releases New Reflection Paper for Labs Performing Clinical Trial Sample Analysis

EMA Releases New Reflection Paper for Labs Performing Clinical Trial Sample Analysis

Posted 09 May 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) announced it has released a new reflection paper to guidance laboratories that evaluate clinical trial samples, which it hopes will establish informal guidelines for laboratories.

The paper, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, will help sponsors to "develop and maintain quality systems which will comply with relevant European Union Directives, national regulations and associated guidance documents," said EMA.

"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."

Noting that sample evaluation and analysis is "a key part of the clinical trials process," EMA writes, "It is essential that sample analysis or evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported."

EMA also noted while comprehensive guidance is not available, and some laboratories have instituted their own guiding principles modeled after Good Laboratory Practices (GLPs), these are modeled off of requirements for non-clinical studies, and are thus not fully applicable to clinical sample testing.

EMA's reflection paper explores the nuances between GLPs and what it sees as acceptable clinical laboratory practices, including:

  • the assignment of responsibilities within a laboratory
  • the utilization of properly trained personnel
  • the establishment of contracts between the laboratory and the sponsor
  • adhering to applicable EMA and EU Directives and regulations
  • subcontracting work to other laboratories
  • maintaining the safety and privacy of involved patients and subjects
  • maintaining a documented chain of custody of all samples
  • ensuring all methods of evaluation are validated
  • documenting any repeat analysis conducted on a sample
  • proper recording procedures for collected data
  • proper reporting procedures for collected data
  • the maintenance of testing facilities that adhere to guidelines for size, location, segmentation and cleanliness
  • the maintenance of all testing equipment
  • the validation of computerized systems used to capture, process, report and store data
  • the establishment and maintenance of quality assurance and quality control processes
  • the establishment of standard operating procedures
  • ensuring staff testing samples are blinded to maintain impartiality



Read more:

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

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