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 ([email protected]) 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: