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Guidelines for the Development of Plans for Back-Up Labs

Back-Up Cryo Labs

The IQA maintains a list of back-up PBMC cryopreservation labs enrolled in the IQA PBMC Cryopreservation Proficiency Testing Program.

More information

In certain circumstances (e.g., analyzer repair or breakdown, lack of available consumables, lack of required reagents or control material, continued failure in an EQA program or internal QC issues), a laboratory may need to use back-up equipment or a back-up laboratory for testing and reporting study specimen results. To ensure the safety of research subjects and the quality of data produced using back-up equipment, the primary testing laboratory must be able to demonstrate acceptable testing proficiency and equivalency between the primary and back-up instruments and/or laboratories for the relevant analyte(s) using tools such as laboratory audit reports, EQA history, instrument validations, comparison checks, and reference ranges.

The development and approval of a back-up plan that demonstrates equivalency between back-up instruments and/or laboratories is the responsibility of the director of the primary testing laboratory.

These guidelines are intended to provide information for the directors of clinical laboratories that perform testing for DAIDS-sponsored clinical trials. They outline the most thorough and ideal approach to developing and approving a back-up plan. However, the director of the primary laboratory may need to deviate from these guidelines depending on the analyte and the testing options available.
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