The Global Alliance for TB Drug Development (TB Alliance) commissioned an assessment of the capacity and readiness of clinical trial sites and their associated mycobacteriology and safety laboratories to conduct clinical studies in human subjects in accordance with the guidelines of the International Conference on Harmonization (ICH) i.e. ICH Topic E 6. Guideline for Good Clinical Practice (EMEA, April 1997) and Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (FDA, April 1996) www.ich.org.

These assessments were commissioned by the TB Alliance and conducted across the globe on 5 continents and in 25 countries. A comprehensive site and laboratory evaluation questionnaire was developed and used to conduct the assessments in a consistent manner across the sites.

The assessments were conducted by two Clinical Research Organisations and with the assistance of two internationally-recognized Mycobacterium tuberculosis laboratory experts to ensure quality of TB laboratory evaluations ,i.e. Dr. Kathleen Eisenach, University of Arkansas for Medical Sciences, USA and Dr Frederick Sirgel, Medical Research Council, South Africa,

The assessment reports present only information within the scope of the evaluation questionnaire and only information that was gathered at the time of the assessment. Sites and laboratories may have changed since the assessments were carried out. Consequently, the TB Alliance provides no assurance or guarantee that the assessments are complete or up to date. The assessments are for informational purposes only. In particular, it is imperative that any one interested in conducting a clinical trial or other study at any of these sites should conduct a pre-study, protocol-specific assessment before deciding the appropriateness of any site for their particular study and should also assure proper monitoring. Please contact the site and laboratory directly for more information.