Start Up Visit Review Sheet 2025

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We describe a novel measure for newer generation devices: the first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass.
The achievement of the first patient enrolled (FPI) into a clinical trial is one of the most highly anticipated events of the clinical development process.
Progression-free survival (PFS) is defined as the time from random assignment in a clinical trial to disease progression or death from any cause.
The Site Initiation Visit (SIV) is required to prepare and set up a research site to conduct a study and must occur prior to patient recruitment. The principal investigator (PI) must attend this visit together with as many members of the research team as possible.
Functional Performance Inventory (FPI)
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An Investigator Site File (ISF) should be established at the beginning of each clinical trial. The ISF contains the minimum list of essential documents that have to be maintained throughout the clinical trial.
The essential documents for clinical trials are the following: Investigators Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form. Clinical Study Reports. Case Report Form (CRF)

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