Data processing: database and file management or data structures – Database design – Data structure types
Reexamination Certificate
1996-08-28
2001-03-27
Feild, Joseph H. (Department: 2771)
Data processing: database and file management or data structures
Database design
Data structure types
Reexamination Certificate
active
06209004
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method and system for creating and distributing sets of related documents.
Traditionally, documents are considered as discrete paper records representing textual or other information. In recent years, a broader definition of documents has been adopted that incorporates storage of the underlying document information in electronic form. That can include graphic or other information displays derived from separate computer programs and exported into a computer word processor program and stored as a single computer file in word processor format. Many documents are functionally linked to other documents that deal with a particular business or academic function and can be referred to as ‘Document Sets’.
Conventional word processor documents store document information in a form fundamentally different from the form used for storage of much of the other data related to the documents (e.g., other data on a business project). Accordingly, integration of the information contained in these disparate documents, Document Sets and databases is difficult, and frequently involves repeated entry of the same information into multiple data storage devices. The Author of a document generated by a word processor does not have easy guidance on the format and content requirements of a given document type. The Author also lacks electronic access to relevant information contained in other documents or databases. Electronic transmission of a document (e.g., via computer networks) is performed by transmission of the entire electronic file for the document, regardless of whether some components of the electronic file are already present at the computer site receiving the document.
For example, Clinical Research Studies of a new drug for use in human disease require a Document Set for each Clinical Study. Each such Clinical Study requires a number of ‘documents’ that are primarily text-based descriptions of various Clinical Study features, such as design and implementation agreements, instructions, and records of implementation of the Clinical Study. The central document for a Clinical Study is the ‘Protocol’ which is a written description of how the Clinical Study will be conducted by an Investigator studying the drug in normal volunteers or patients with disease. In addition, other documents related to Clinical Studies are required. Documents in Clinical Study Document Sets are largely based on the underlying design of the Clinical Study, as represented by a series of actions performed at specified times.
It is therefore desirable to generate Document Sets in a manner that facilitates document creation, integration with other databases, efficient transfer of documents and related files between computers, linkage of related documents so as to access information from a common store, and enforcement of standards to be applied to such documents.
2. Description of the Prior Art
Documents are conventionally generated using either a typewriter or a computer word processor, but these methods have the disadvantage that they do not provide, or have limited capacity for, the following:
Relational Database: Storage within a relational database of document data, structural information, rules and Dependencies, so as to permit linking of comparable data residing in different sections of an individual document or in different documents, sophisticated searching, integration and analysis of the data, and analysis of data across multiple Document Sets. In addition, storage of document data in a relational database facilitates exchange of information between non-document relational databases that contain information functionally related to the information in the documents.
Time/Action Electronic Matrix: A central control mechanism for Document Sets based on an electronic matrix of time periods and associated actions.
Enhanced Electronic dissemination of Documents: Transfer of a document between computers by confining transmission to those portions of a document that are document-specific—i.e., those portions that are not shared by all other documents of the particular type.
Automatic regeneration of Dependent documents or document components: Dependency of a document or document section implies that it requires updating when a given data item shared within or across documents is changed.
Automatic updating and reconciliation of Data: Data from different documents within a Document Set or across multiple Document Sets can be automatically updated and reconciled.
Enforcement of Format and Content Requirements: Computer-controlled mechanism for avoiding document format violations and document information omissions.
For Clinical Research Studies, the following document types share linked information:
Clinical Study Protocol.
Investigator-Related Documents: Investigator Protocol Approval Forms, Correspondence, Telephone Contact Form, Site Visit Report Forms, Investigator Check Lists, Investigator Instructions.
Patient Documents: Patient Instructions, Documents to record Other Patient Data.
Regulatory Authority Documents: Clinical Study Summary; Integrated Summary of Safety; Integrated Summary of Efficacy; Other IND and NDA documents; Correspondence.
Serious Adverse Event (SAE) Documents: SAE Protocol Inventory Form, SAE Patient Report Form.
Budget Documents: Generic Budget, Investigator-specific Budget.
Informed Consent Form (ICF) Documents: Generic and Investigator-specific ICFs.
Other Internal Sponsor Documents: Memoranda; Internal Check Lists; Internal Approval Forms (for Protocol, ICF, budget, Case Report Form, drug supply request).
Other Document Types: Case Report Order Form, Drug Supply Order Form, Sample Size Estimation Form.
A ‘Sponsor’ of a Clinical Study is the organization responsible for filing the Clinical Study with the Food and Drug Administration (‘FDA’) and is normally a pharmaceutical company. Most Sponsors use a word processor to write Protocols and other documents required in a Clinical Study, frequently by copying sections of previous documents and editing these. The ‘Author’ (i.e., the person writing the Protocol) is not forced during Protocol writing to address all of the key items in writing a Protocol, so that major omissions and errors may be frequent. Even though a Sponsor may have a ‘standard format’ for Protocols, this may not be followed by Authors—so that the task of those reviewing and approving the Protocol is more difficult. Photocopies of the Protocol are normally distributed for internal review and for hand-written comments to be written on the copy. The Protocol exists as a word processing file that limits search capabilities (e.g., dosage used across Protocols). Normally a separate form containing key Protocol items for the Sponsor's Serious Adverse Event database is hand-generated and these data are then entered into a separate computer database. Many disparate Clinical Study databases exist in pharmaceutical companies and integration of these databases has become a significant issue with the pharmaceutical industry and FDA—with significant medico-legal and regulatory implications.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide enhanced methods and systems for creating Document Sets containing documents that share common information, and for providing more efficient electronic transfer of documents and other electronic files between computers.
In accordance with a preferred embodiment of the present invention, a method and system are used to format, define, generate, maintain, distribute and analyze documents. Document-specific data are stored in a relational database which allows dynamic two-way data exchange with document templates containing information common to all documents of a specific document type; a complete document is assembled by combining the data in the template and relational database.
In accordance with another embodiment of the present invention, Document Sets (groups of documents belonging to sets of related document types that share common informa
Feild Joseph H.
Helfgott & Karas P.C.
Kindred Alford W
Taylor Microtechnology Inc.
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