Automated methods and systems for changing a clinical study in progress

A system for implementing a change to a clinical study in progress, the system comprising:

• (a) a plurality of study participant computers for collecting patient diary information from study participants;
• (b) a collector operatively associated with the study participant computers for receiving the patient diary information from the study participant computers and for automatically changing software executing on the study participant computers;
• and
• (c) a diary database operatively associated with the collector for receiving and storing the patient diary information and for storing change data for changing the software executing on the study participant computers.

A computer program product comprising computer executable instructions embodied in a computer-readable medium for performing steps comprising:

• (a) receiving patient diary data from a study participant computer;
• (b) in response to receiving the patient diary data from the study participant computer, determining whether any study changes have been defined for the study participant computer;
• and
• (c) in response to determining that a study change has been defined for the study participant computer, automatically downloading the study change to the study participant computer.

A computer program product comprising computer-executable instructions embodied in a computer readable medium for performing steps comprising:

• (a) receiving clinical study change data at a participant computer;
• (b) executing software for collecting patient diary data from a study participant;
• (c) detecting an event associated with the data collection;
• (d) in response to the event, determining whether the change data includes an override function for handling the event;
• and
• (e) in response to detecting that the override function is present, executing the override function in place of a default function for handling the event.