Patent ID: 7444293
Filing Date: 2008-10-28
Classification: G16H,Y10S

Abstract:
1. A method for evaluating a clinical trial protocol specification, comprising the steps of: encoding into a database, workflow tasks called for in a clinical trial protocol specification not yet in execution, including substeps of writing, into protocol specification objects of said database, specifications of protocol events that said protocol specifies to occur during execution of said protocol, and relationships that said protocol specifies among said protocol events; during said step of encoding workflow tasks but not during any of said substeps, identifying an operational uncertainty in which said protocol specification contains at least one of the following deficiencies: said protocol specification fails to specify a particular parameter for use during protocol execution, or said protocol specification specifies such a parameter with less precision than is required by a slot in said database for encoding the parameter, or said protocol specification contains at least two such parameter specifications which are in conflict; encoding into said database in association with at least a particular one of said protocol specification objects in said database, before execution of said clinical trial protocol, an indication that said operational uncertainty exists with respect to said particular object; and in dependence upon protocol specification objects in said database, before execution of said clinical trial protocol, displaying a graphical-visual representation of said protocol, said graphical-visual representation including a human-perceptible indication that said particular protocol specification object has said operational uncertainty associated therewith.