Data processing: presentation processing of document – operator i – Presentation processing of document – Layout
Reexamination Certificate
2005-08-02
2005-08-02
Feild, Joseph (Department: 2176)
Data processing: presentation processing of document, operator i
Presentation processing of document
Layout
C715S252000, C713S155000, C705S003000
Reexamination Certificate
active
06925599
ABSTRACT:
For drug clinical studies validation methodology; 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.
REFERENCES:
patent: 5666490 (1997-09-01), Gillings et al.
patent: 6205455 (2001-03-01), Umen et al.
CliniSys, Inc.
Feild Joseph
Glynn Kenneth P.
Nguyen Maikhanh
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