General introduction for endTB website

The endTB Clinical Trials are international, open-label, Phase III, non-inferiority, randomized, controlled clinical trials. They were led by a consortium including Médecins Sans Frontières (MSF), Partners In Health (PIH), and Interactive Research and Development (IRD), with MSF France being the Sponsor of the endTB Clinical Trials.

The standard documents were developed by Sponsor specialists with expertise in each field (e.g., clinical investigators for medical documents, Pharmacovigilance unit for safety assessment and reporting documents, etc.). Our goal is to share these documents with anyone interested in endTB materials and working in resource-limited locations. Although, these standard documents were developed for tuberculosis clinical trials, they can be modified and extrapolated to meet the specific project needs. Please note that the standard documents should only be considered updated to the date of final approval and that the Sponsor does not bear responsibility for their use.

For now, only medical, pharmacovigilance and Observational study standard documents are being shared. The other categories of documents (Data management, Quality, Pharmacy, TB laboratory) will be added gradually and at the latest by end of December 2024. These standard documents were routinely reviewed and updated as required. All standard documents are controlled documents and are available as .docx documents. They are followed by appendices, labeled with the letter A in the title, as needed.