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Operation and method for prediction and management of the validity of subject reported data

  • US 9,881,062 B2
  • Filed: 07/06/2015
  • Issued: 01/30/2018
  • Est. Priority Date: 04/02/2001
  • Status: Expired due to Term
First Claim
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1. A computer implemented method for improving clinical trial data quality, comprising steps of:

  • obtaining compliance information from a subject in said clinical trial on a portable electronic device, wherein said compliance information comprises data on timeliness in answering a question or responding to a prompt by said subject;

    receiving on a server, over a network from said portable electronic device said compliance information;

    applying a decision rule to said compliance information;

    determining, based at least on application of said decision rule to said compliance information, that an action should be taken;

    identifying a type of action automatically; and

    displaying said type of action on an electronic device, wherein said type of action is displayed to a subject, a research site, a sponsor or a clinical trial staff, thereby improving clinical trial data quality.

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