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Lab Documents

Lab Documents

Requirements

  • Current Lab Certification (e.g. CLIA, CAP)
  • Normal Lab/Reference Values 

Tips / Additional Information

  • Keep updated lab documents to document the competency of all lab facilities being utilized, and to support the reliability of test results.
  • If lab documents are filed electronically or separately, include a signed and dated note to file indicating the location.
  • Research laboratories typically do not have lab certifications (e.g. CLIA, CAP). In the case of research laboratories, ensure that the research lab reference values are on file.
  • CLIA and all other licensure for all UCLA labs can be found here:  UCLA Clinical Laboratories Licensing & Accreditation Documents
  • You will also need the CV of the lab manager for your regulatory binder. Please contact UCLA Pathology & Laboratory Medicine to obtain a copy.
  • Reference values: UCLA Health Laboratory Test Directory

Applicable GCP Sections: 

  • 8.2.11
  • 8.2.12
  • 8.2.14
  • 8.3.6
  • 8.3.7

Last updated: 30 Nov 2022


Source URL:https://www.researchgo.ucla.edu/regulatory-binder-lab-documents