Methods and Systems for Clinical Trial Data Management

• US 20060259783A1
• Filed: 04/27/2006
• Published: 11/16/2006
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: The Therapeias Health Management LLC
• Original Assignee: The Therapeias Health Management LLC
• Inventors: Ito, Masashi, Work, Telford, Work, William
• Granted Patent: US 7,783,072 B2
• Time in Patent Office: Days
• US Class Current: 713/189
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

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.

Claims

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.

2. The method of claim 1, wherein said original information comprises original clinical trial data.

3. The method of claim 1, wherein said certified copy resides at a location remote from said user.

4. The method of claim 1, wherein said first digital version is provided by scanning said original information.

5. The method of claim 1, further comprising filtering said first digital version of said original information, thereby providing said second digital version of said original information.

6. The method of claim 1, further comprising re-authenticating said user after said certifying step, wherein said re-authentication comprises said user providing a token to said computer system.

7. The method of claim 1, wherein said certifying step is accomplished by electronic signature.

8. The method of claim 1, wherein said first and second fingerprints are checksums of said second digital version.

9. The method of claim 1, further comprising committing said second digital version of said original information when said first and second fingerprints are the same.

10. The method of claim 1, further comprising transmitting a receipt to said user after comparing said first and second digital fingerprints, wherein said receipt comprises at least one encrypted signature of said certified copy.

11. A method for providing a certified copy of a clinical trial document, comprising:

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.

12. The method of claim 11, wherein said certified copy resides at a location remote from said user.

13. The method of claim 11, wherein said re-authenticating said user comprises said user providing a token to said computer system.

14. The method of claim 11, further comprising filtering said first digital version of said document, thereby providing said second digital version of said document.

15. The method of claim 11, further comprising transmitting a receipt to said user after comparing said first and second digital fingerprints, wherein said receipt comprises at least one encrypted signature of said certified copy.

16. A computer system for certifying a copy of a document, comprising:

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.

17. The computer system of claim 16, wherein said computer code for authenticating said user based on said user identification and said computer code that compares a first and second fingerprints of said second digital version of said document to detect if the fingerprints are the same are stored on a different computer readable medium than the other said computer codes.

18. The method of claim 16, further comprising computer code that filters said first digital version of said document thereby providing said second digital version of said document.

19. The computer system of claim 16, further comprising computer code that commits said second digital version if said first and second fingerprints are the same.

20. A business method of managing electronic medical documents, comprising:

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.

21. The method of claim 20, wherein said electronic medical documents are certified copies of clinical trial documents.