Established approaches for clinical trial performance (eg, Good Clinical Practice) and reporting (eg, CONSORT) provide the basis for ethical research.1,2 To safeguard credible results and conclusions while minimizing potential harm, the following items are necessary for successful trial implementation: involvement of protocol and steering committees, oversight by an independent safety monitoring committee, adherence to local research regulations (institutional review board [IRB]), trial registration in an international repository before initiating patient enrollment (eg, ClinicalTrials.gov or EudraCT), and maintenance of high-quality clinical trial procedures (eg, randomization processes, informed consent, adverse event reporting, data collection and analyses, and safety stopping criteria).3- 5 In this article, we describe critical components of trial implementation, oversight, and regulatory aspects that are necessary in high-quality clinical trials (Box).