This template is applicable to most studies, including observational studies, pre/post-intervention studies, case/control studies, biological sample collection, qualitative studies, cross-sectional studies, and studies that randomized into standard of care treatment. This template should NOT be used for studies which involve new investigative drugs or devices. These types of studies require an expanded protocol with additional detail such as dosing, reporting of adverse events, etc.

Click here to download the Clinical Research Protocol Template