Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories.

@article{Ezzelle2008GuidelinesOG,
  title={Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories.},
  author={J Ezzelle and Isaac R. Rodriguez-Chavez and Janice M. Darden and Michael Stirewalt and N. Kunwar and Robert Hitchcock and Thomas K Walter and M Patricia D'souza},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2008},
  volume={46 1},
  pages={18-29}
}
A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing… CONTINUE READING
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