Methods and apparatus for the centralized collection and validation of geographically distributed clinical study data with verification of input data to the distributed system

  • US 6,496,827 B2
  • Filed: 01/28/2000
  • Issued: 12/17/2002
  • Est. Priority Date: 05/12/1997
  • Status: Expired due to Term
First Claim
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1. A computer-based method for centralized collection of geographically distributed information from at least one user at a remote site computer, comprising:

  • obtaining data from a clinical trial;

    receiving said clinical trial data from the at least one user with the remote site computer;

    checking the data for validity with the remote site computer;

    providing the user an opportunity to correct any invalid data found during the checking;

    transmitting the data to a centralized computer over a transmission medium;

    receiving and validating the data from the remote site computer at the centralized computer, including comparing the data to data already stored at the centralized computer to determine if it is valid or invalid;

    if the data from the remote site computer is determined to be invalid, then performing the following until all data is determined to be valid;

    signaling with the centralized computer to the remote site computer to provide the user an opportunity to correct invalid data;

    transmitting corrected data from the remote site computer to the centralized computer; and

    receiving and validating the corrected data from the remote site computer at the centralized computer, including comparing the corrected data to data already stored at the centralized computer to determine if the data is valid or invalid;

    when all data has been determined to be valid, then entering and storing the valid data in a central database at the centralized computer.

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