Virtual Regulatory Binder: Lab Documents

Last revised: 
11/19/2015

Requirements

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

QIU 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 UCSF labs can be found here:  UCSF Clinical Laboratories Licensing & Accreditation Documents
  • CLIA and all other licensure for San Francisco General Hospital (SFGH) can be found here:  Lab Manual for SFGH (including CLIA certification)
  • You will also need the CV of the CLIA Laboratory Director for your regulatory binder. Email Dr. Edward Thornborrow directly (Ed.Thornborrow@ucsf.edu) detailing the patient population (Adult, Peds, Oncology, etc) and the tests that will be performed in-house in support of the study. Based on this he will be able to determine which Director(s) is/are involved and what CV(s) you will need.
  • Reference values: http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/index-normal.html

Applicable GCP Sections: