Understanding Protocol Complexity Produces More Accurate Investigator Site Budgets


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Protocol complexity metric, also known as site work effort (SWE), measures the effort required by site staff to implement the procedures in a clinical trial protocol. This metric is based on the amount of time that it takes for the investigative site to perform a procedure called for in the protocol and the skill level required to administer that procedure. The skill level required has been validated by investigators working with the Tufts Center for the Study of Drug Development under a project led by Kenneth A. Getz, MBA, and Director of Sponsored Research Programs. Procedures that are not reimbursable by third parties, such as informed consent…

Oncology, Breast Cancer, Phase III

Frank Cattie
, VP, Trial Planning Solutions (TPS), Medidata Solutions. Medidata Solutions Worldwide is a global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For more information, visit