Transcription of Reflection paper on laboratories that perform the analysis ...
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Reflection paper on laboratories that perform the analysis ...
28 February 2012. EMA/INS/GCP/532137/2010. GCP Inspectors Working Group Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples Draft agreed by GCP Inspectors Working Group 10 June 2010. Adopted by GCP Inspectors Working Group for release for consultation 10 June 2010. Start of public consultation 23 September 2010. End of consultation (deadline for comments) 28 February 2011. Adopted by GCP Inspectors Working Group 28 February 2012. Keywords Clinical laboratory, Laboratory analysis , Clinical Trial 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416.
required by the protocol. Samples may include but are not limited to: blood, plasma, serum, urine, faeces, tissues and cells. “Laboratory” means a facility that conducts the analysis or evaluation of samples collected as part of a clinical trial; such analysis or evaluation may include the generation of pharmacokinetic data, safety
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