System and Method for Management of Research Subject or Patient Events for Clinical Research Trials

A method for managing research subject or patient events for clinical research trials comprising:

• entering clinical research trial configuration information into a centralized secure database through a high-clearance interface;
• entering clinical research trial data into one or more investigator databases through an investigator interface;
• periodically transferring said clinical research trial data residing in said one or more investigator databases to said centralized secure database and periodically transferring limited datasets from said centralized secure database to an administrator database and to said one or more investigator databases;
• monitoring and analyzing said limited datasets in said administrator database with an administrator interface;
• providing prompts to investigators and/or participants through at least one communication gateway;
• and
• recording said prompts in said centralized secure database.