METHOD AND APPARATUS FOR ADMINISTERING CLINICAL TRIALS

摘要

A system and method for administering a clinical trial centralizes all trial communications in a website system. The system enables a trial sponsor to create individual websites for each of its available trials using website templates driven by workflow management software. The prospective clinical investigator can browse current and upcoming clinical trials and select trials that he/she wants to participate in. The clinical investigator can register interest in the trial by entering their contact information and professional credentials to create a personal profile. The trial sponsor can search for prospective clinical investigators whose credentials are commensurate with those required for a clinical trial. The trial sponsor also can invite prospective clinical investigators to participate in clinical trials. The system programmatically creates a secure account the clinical investigator can use to access the clinical trial website (called a collaboration portal). Once the clinical investigator logs into the collaboration portal, he/she is able to appoint sub-investigators and additional administrative accounts for the portal. The clinical investigator also uploads essential trial documentation via the collaboration portal into the document repository that the trial sponsor set up for the clinical trial. The investigator portal also gives the principal investigator a central place to access clinical trial alerts, notifications and a to-do list.