Software architecture and system for performing validated...

Data processing: presentation processing of document – operator i – Presentation processing of document – Hypermedia

Reexamination Certificate

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C715S229000, C715S255000, C715S234000, C726S026000, C713S179000

Reexamination Certificate

active

07669114

ABSTRACT:
Software, and a master system with hardware and connections, for validated drug clinical studies includes: creating data collection documents with unique identifiers; having operators complete security identification verification before proceeding; having secured operators fill out and sign specified data collection documents; creating permanent records of the preceding; tracking by unique identifiers in a local system; uploading to a central system; independently reviewing filled out signed data collection documents to accept or require clarifications; keeping permanent read only records of all originally filled out and signed documents; making document clarification requests; reviewing each response; assigning new unique identifier links to each version of every revision; iteratively repeating the above until the documents are clean, and storing and tracking every version of every document in the central system; providing a monitor query and document entry history of all changes to all documents to create a secured audit trail.

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CDC Solutions: “Planning Your Transition to: Electronic Document Management Systems” Registration Form, Madison Hotel, Washington, DC, Mar. 23-25, 1994.
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CDC Solutions: ATLIS Consulting Group, Inc., “The CANDA Cook-Book; Preparing for Standards-Based CANDAs: A How-To-Guide”, Jan. 1994, pp. 1-31.

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