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), 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 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 DAIDS-sponsored 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.

• Guidelines for the Use of Back-Up Equipment and Back-Up Clinical Laboratories in DAIDS-Sponsored Clinical Trials Networks Outside of the USA