Skip to main content

Protocol Analysis

In discussions with the sponsor’s study team the Clinical Trial Liaisons (CTLs) first record the status and parameters of the study (indication and phase, case number, timelines, participating trial sites, monitoring, etc.) as well as the results of an eventually already conducted feasibility analysis. This provides them a first impression which challenges for patient recruitment exist.

The CTLs analyse the trial protocol using a defined catalogue of questions regarding the patient recruitment potential and the operational and administrative challenges of the study. Thereby they direct their attention to the characteristics of the patient clientele addressed, the integrability of the study visits with the patients’ daily routines, the summer dresses motivation of the patients to participate in the study, the in- and exclusion criteria, allowed and prohibited concomitant medication, the procedures and devices to be applied, the prerequisites for suitable trial sites, the effectivity, efficiency and practicability of the study processes as well as competing studies.