Abstract: A system and method providing passive verification of participant—typically a physician—exposure to Material equivalent to attendance at an Investigator Meeting prefatory to Clinical Trial is taught. The invention provides for rendering media capture of Investigator Meeting education into computer deliverable sessions, and further into segments, where segments are the product of randomly generated visual requests to which participant need provide response in some prescribed time interval to confirm visual attention to Material. To ensure participant visual exposure to Material, during computer mediated display of Material, visual prompts appear at random points in the display. For any successful participant response, session advances, and in absence of successful response, display of Material resets to last successful response point in Material. In an alternate embodiment, groups of viewers may be tracked corresponding to a group viewing of Material.

Abstract: A system and method providing passive verification of participant—typically a physician—exposure to Material equivalent to attendance at an Investigator Meeting prefatory to Clinical Trial is taught. The invention provides for rendering media capture of Investigator Meeting education into computer deliverable sessions, and further into segments, where segments are the product of randomly generated visual requests to which participant need provide response in some prescribed time interval to confirm visual attention to Material. To ensure participant visual exposure to Material, during computer mediated display of Material, visual prompts appear at random points in the display. For any successful participant response, session advances, and in absence of successful response, display of Material resets to last successful response point in Material. In an alternate embodiment, groups of viewers may be tracked corresponding to a group viewing of Material.

Abstract: The invention provides a method and system for efficiently apportioning, delivering and monitoring training to clinical trial participants. The invention ensures that each person participating in a given clinical trial receives only the training that they actually need in order to perform their assigned tasks on the trial. The invention reduces the amount of unnecessary training typically taken by staff working on a clinical trial, accelerates the startup of the trial and ensures that staff receives the necessary training for the specific tasks they are performing on the trial.

Abstract: The invention provides a system that manages version changes of regulatory training and update training plans for those users who are affected by the change based on a set of rules defined by the clinical trial sponsor. The system also provides custom updated training plans when different sponsors have different rules affecting regulatory training updates.

Abstract: The invention provides a system and method optimized for clinical trial training management. The inventive system and method collect training records across all training venues and platforms that are internal and external to any organization, provide a simple and efficient means to report on each and every training requirement and the satisfaction of training requirements for each clinical trial staff, and for each clinical trial site; and produce images of any and all certificates or records of attendance pertaining to satisfaction of any training requirement, thereby enabling clinical trial sponsor access to auditable records.

Abstract: The invention provides an efficient approach to qualifying raters to serve in a clinical trial or study, where efficiency includes all aspects pertinent to study raters: creating of qualification profile; identification of appropriate study sites and raters, selection, training, and supplemental qualification of raters during the course of a clinical study or trial, as may be necessitated by study protocol changes or other changes that may occur.

Abstract: A system and method providing passive verification of participant—typically a physician—exposure to Material equivalent to attendance at an Investigator Meeting prefatory to Clinical Trial is taught. The invention provides for rendering media capture of Investigator Meeting education into computer deliverable sessions, and further into segments, where segments are the product of randomly generated visual requests to which participant need provide response in some prescribed time interval to confirm visual attention to Material. To ensure participant visual exposure to Material, during computer mediated display of Material, visual prompts appear at random points in the display. For any successful participant response, session advances, and in absence of successful response, display of Material resets to last successful response point in Material. In an alternate embodiment, groups of viewers may be tracked corresponding to a group viewing of Material.

Abstract: The invention provides a consistent, easy to use, reliable method for evaluating each potential subject against the inclusion and exclusion criteria for a controlled data collection such as a clinical trial protocol. The invention provides a method for subject evaluation according to the clinical protocol as soon as the clinical protocol has been agreed upon. The invention provides an automated system and method of applying the clinical protocol to identifying and enrolling subjects. The invention removes both error (based on incomplete understanding or misunderstanding of the protocol) and inconsistencies owing to the subjective application. Further, to the extent physician subjectivity is affecting enrollment, the inventive system and method provides a means to monitor and quantify the subjective effect introduced into the clinical trial enrollment process.