The elements of planning, protocol development, implementation, and the lessons learned in the multi-site MACH-19 study featured in the JAMA (Journal of the American Medical Association) Newsletter are instructive for anyone considering clinical research with Chinese herbs. Challenges faced and solutions implemented at different stages of planning, development, carrying out the trial and its final completion will be discussed. This seminar will examine relationship building and roles of team members including principal investigators, co-investigators, project manager, study coordinators, statistician, and herbal subject matter experts, as well as interaction with universities and outside organizations including the FDA and DEA.