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Electronic data capture in clinical and pharmaceutical trials

  • US 8,870,762 B2
  • Filed: 12/20/2006
  • Issued: 10/28/2014
  • Est. Priority Date: 03/28/1997
  • Status: Expired due to Fees
First Claim
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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.

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