Abstract
Site visits are planned activities of large multi-institutional prospective clinical trials. Although, these visits are planned differently for different trials depending on complexity and number of participating sites, it is not uncommon to have a pre-qualification site visit, an initiation site visit, monitoring site visits, and close-out site visits. Unplanned or planned site visits can be conducted by the FDA or sponsor for trials involving new drugs or medical devices. These site visits can also be the result of monitoring findings or for quality assurance purposes. For research funded by the Department of Health and Human Services, the Office for Human Research Protections can also conduct site visits for cause or not for cause.
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Itani, K.M.F. (2017). Site Visits. In: Itani, K., Reda, D. (eds) Clinical Trials Design in Operative and Non Operative Invasive Procedures. Springer, Cham. https://doi.org/10.1007/978-3-319-53877-8_38
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DOI: https://doi.org/10.1007/978-3-319-53877-8_38
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