Patent ID: 7596541

Claim:
A computer based method for authenticating an ongoing clinical trial is conducted in accordance with procedural guidelines, comprising the steps of: conducting said ongoing electronic clinical trial comprising a plurality of tests according to procedural guidelines established by a clinical trial administrator over a communications network; selecting a test from said plurality of tests of said ongoing electronic clinical trial to be performed by said trial participant using a computing device connected to said communications network and associated with said trial participant; providing said informed consent if it is determined that said selected test of said ongoing electronic clinical trial requires a consent, wherein said informed consent signifies that said trial participant understands aspects of said selected test of said ongoing electronic clinical trial and agrees to participate in performance of said selected test of said ongoing electronic clinical trial; performing said selected test of said ongoing electronic clinical trial by said trial participant to provide trial data if said informed consent is not required or if said informed consent is required and provided by said trial participant; accepting and recording said trial data of said trial participant in a database connected to said communications network, thereby providing an authentication that trial data recorded in said database occurred in accordance with said procedural guidelines; scheduling one or more periods for accepting said trial data; scheduling said plurality of tests to be performed during said one or more periods; defining a plurality of elements for each of said plurality of tests; identifying a plurality of exceptions for setting limits on said trial data; alerting said trial participant to perform a scheduled test; and continuously attempting to reach said trial participant if said trial participant fails to reply.