Methods and Systems for Clinical Trial Data Management
First Claim
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1. A method for providing an electronic certified copy of original information, comprising:
- authenticating a user of a computer system based on a user identification;
said user providing a first digital version of said original information;
said user certifying that a second digital version of said original information is the same as said first digital version; and
comparing a first fingerprint of said second digital version with a second fingerprint of said second digital version to ensure said first and second fingerprints are the same, thereby providing an electronic certified copy of said original information.
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Abstract
The invention provides systems and methods for creating certified copies of original information, including original hardcopy documents, in compliance with federal regulations and guidelines. The present invention also provides systems and methods of data management, and in particular, management of such certified copies. In some embodiments the invention relates to original clinical trial information such as source documents, and methods and systems for creating certified copies of such information to create an accessible central repository of such certified copies.
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Citations
21 Claims
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1. A method for providing an electronic certified copy of original information, comprising:
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authenticating a user of a computer system based on a user identification;
said user providing a first digital version of said original information;
said user certifying that a second digital version of said original information is the same as said first digital version; and
comparing a first fingerprint of said second digital version with a second fingerprint of said second digital version to ensure said first and second fingerprints are the same, thereby providing an electronic certified copy of said original information. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for providing a certified copy of a clinical trial document, comprising:
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authenticating a user of a computer system based on a user identification;
said user providing a first digital version of said clinical trial document by scanning said clinical trial document;
said user verifying said first and second digital versions or said clinical trial document are the same;
re-authenticating said user;
comparing a first digital fingerprint and a second digital fingerprint of said second digital version to ensure said digital fingerprints are the same, thereby providing a certified copy of said clinical trial document. - View Dependent Claims (12, 13, 14, 15)
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16. A computer system for certifying a copy of a document, comprising:
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computer code for providing a user identification;
computer code that authenticates a user based on said user identification;
computer code that provides a first digital version of said document;
computer code that allows a user to certify that a second digital version of said document is the same as said first digital version;
computer code that compares a first fingerprint and a second fingerprint of said second digital version of said document to detect if said fingerprints are the same; and
computer readable medium that store said computer codes. - View Dependent Claims (17, 18, 19)
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20. A business method of managing electronic medical documents, comprising:
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receiving a plurality of electronic medical documents;
storing said plurality of electronic medical documents, thereby providing a repository of medical documents; and
allowing access to said plurality of medical documents from locations remote from said repository, thereby managing electronic medical documents. - View Dependent Claims (21)
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Specification