Harmonization and streamlining of research oversight for pragmatic clinical trials

A guide to research partnerships for pragmatic clinical trials

Karin E Johnson research associate, Chris Tachibana scientific editor and writer, Gloria D Coronado senior investigator, Laura M Dember professor of medicine, Russell E Glasgow associate director, Susan S Huang associate professor and medical director of epidemiology and infection prevention , Paul J Martin medical director , Julie Richards project manager , Gary Rosenthal professor , Ed Septim...

Introducing a Method for Achieving Standardization and Harmonization in Clinical and Research Laboratory Centers

Abstract Background and Objective: Proficiency testing schemes as a part of quality system in clinical and research laboratory centers provides the opportunity to evaluate the quality of test results. In this paper, we try to introduce the proficiency testing schemes as a useful method for achieving standardization and homogenization of test results in clinical and research laboratory center...

Seeking harmonization and quality in clinical trials.

Clinical Trials of TB Vaccines: Harmonization & Cooperation

Four paradigms of clinical research and research oversight.

The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States (Table 1). These paradigms incorporate different values and provid...