Electronic data capture in clinical and pharmaceutical trials

摘要

A system for remotely monitoring an individual. The system includes a server system for generating a script program from a set of queries. The script program is executable by a remote apparatus that displays information and/or a set of queries to the individual through a user interface. Responses to the queries that are entered through the user interface together with individual identification information are sent from the remote apparatus to the server system across a communication network. The server system also includes an automated answering service for providing a series of questions from a stored set of questions for an individual at the remote apparatus to respond to, storing responses to each provided question in the series of questions and providing a service based on the individual's response to the questions.

主权项

1. A method of monitoring a clinical trial, comprising:
A) selecting a program from a number of computer programs stored on a server, wherein said program contains one or more queries and one or more corresponding response choices related to efficacy, side effects and quality of life impact of one or more drugs; B) transmitting the program from said server to a remotely situated apparatus through at least one communication network during a first communication link, wherein the remotely situated apparatus is assigned to a participant of said clinical trial and the program causes the apparatus to present the one or more queries and one or more corresponding response choices to the participant and collect responses, including at least one of the corresponding response choices, from the participant while the remotely situated apparatus is not in communication with said server; C) receiving the responses from the remotely situated apparatus through the at least one communication network during a second communication link and storing the responses in the server, wherein the program causes the remotely situated apparatus to automatically establish the second communication link with the server at a prescribed time and transmit (i) the responses collected from the participant, (ii) a program identification code, and (iii) an identification code associated with the participant; and D) generating a report about said clinical trial based upon the responses, wherein said responses are collected in response to the queries related to the efficacy, side effects and quality of life impact of the one or more drugs with respect to said participant during a clinical development or post marketing surveillance period.