Quality laboratory testing is essential in order to reach the goal of TB elimination. Continual improvements in laboratory testing and standardization must be maintained to ensure quality data is obtained for clinical trials and that sponsors have sufficient confidence in the data to advance products that can ultimately be used to improve TB treatment and control. Thus, it is imperative that the laboratory provides clinical trial sponsors with accurate test results (e.g. smear, culture, drug susceptibility and molecular results) within acceptable turn-around times while providing a safe work environment for laboratory personnel. This self-assessment tool is designed to capture information on best-practices and allows the sponsor an opportunity to review procedures that are in place.
The purpose of this assessment tool is for sponsors to better understand lab capacity and capability, to provide guidance on how to get ready for TB clinical research trials, to help identify areas for improvement, and to help determine whether additional resources should be sought to address any identified areas for improvement. As a result, the document attempts to match laboratory’s capabilities with future TB clinical research needs.