Drug document production system
First Claim
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1. A method for producing a document for regulatory review of a medical product, comprising the steps of:
- a) conducting a plurality of investigational studies of the medical product;
b) entering and storing data objects pertaining to the studies into a computer database;
c) providing a data management user interface configured to produce a status display identifying data objects pertaining to any of said studies for which incomplete information has been entered and stored;
d) providing at least one medical product document template specifying a predetermined order and format for at least a subset of said data objects, and having standard text portions;
e) retrieving said subset of data objects from the database;
f) reproducing, in a document compatible with a word processing system, said retrieved data objects and said standard text portions in the order and format specified within the template;
g) editing the document with the word processor; and
h) updating the database to reflect changes made to a data object during said editing step.
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Abstract
A document production system is provided for preparing documents and managing a database of information pertaining to investigational studies of medical products. The document production system includes a data management user interface for providing user access to the database and for retrieving information from the database as specified by selected document templates for placement into word processor-compatible documents. Additionally, the data management user interface is capable of updating information stored within the database in accordance with information specified within a previously-prepared document.
53 Citations
24 Claims
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1. A method for producing a document for regulatory review of a medical product, comprising the steps of:
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a) conducting a plurality of investigational studies of the medical product; b) entering and storing data objects pertaining to the studies into a computer database; c) providing a data management user interface configured to produce a status display identifying data objects pertaining to any of said studies for which incomplete information has been entered and stored; d) providing at least one medical product document template specifying a predetermined order and format for at least a subset of said data objects, and having standard text portions; e) retrieving said subset of data objects from the database; f) reproducing, in a document compatible with a word processing system, said retrieved data objects and said standard text portions in the order and format specified within the template; g) editing the document with the word processor; and h) updating the database to reflect changes made to a data object during said editing step. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for producing a document pertaining to a study of a medical product, comprising the steps of:
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a) entering and storing data objects pertaining to the study into a computer database; b) providing at least one medical product document template specifying a predetermined order and format for at least a subset of said data objects, and having standard text portions; c) retrieving said subset of data objects from the database; and d) reproducing, in a document compatible with a word processing system, said retrieved data objects and said standard text portions in the order and format specified within the template; and wherein said step of entering and storing data objects comprises; a) defining at least a first and second type of data object; b) embedding a data object of said first type within at least one of said data objects of said second type; and c) storing said one data object of said second type in said database with a coded reference to said embedded data object of said first type.
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9. An apparatus for computer-aided composition and generation of a document for regulatory review of a medical product, comprising:
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a word processor for editing the document; a data storage and retrieval system comprising a database structured to provide access to at least two classes of information pertaining to plurality of medical product investigational studies, the classes including a class of detail objects and a class of test objects, the database being structured for storing references to detail objects embedded within the text objects; a data management user interface operable concurrently with the word processor for providing a plurality of executable procedures for manipulating information within the database; at least one medical document template for specifying the structure of a respective medical product document, the template included coded references in detail to objects and text objects for use in the medical product document in accordance with a selected format; and document generation means accessible by the data management user interface for retrieving detail objects and text objects specified within the template, and for arranging the retrieved detail objects and text objects into a medical product document compatible with the word processor in accordance with the template. - View Dependent Claims (10, 11, 12)
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13. A method for producing hierarchically related documentation for regulatory review of a medical product, comprising the steps of:
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a) conducting a plurality of investigational studies of the medical product; b) creating data objects pertaining to the studies in at least one computer database; c) providing at least one medical product documentation template specifying a predetermined order and format for at least a subset of said data objects, and having standard text portions; d) retrieving said subset of data objects from the database; e) generating, in documentation compatible with a word processor, said retrieved data objects and said standard text portions in the order and format specified within the template; f) labeling objects in the generated documentation with non-printable delimiter codes; g) editing the generated documentation with the word processor; and h) updating the database to reflect changes made to labeled data objects during said editing step. - View Dependent Claims (14, 15, 16)
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17. An apparatus for computer-aided composition and generation of a document for regulatory review of a medical product, comprising:
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a word processor for editing the document; a data storage and retrieval system comprising a database structured to provide access to data objects pertaining to a plurality of medical product investigational studies; a data management user interface adapted to be loaded into executable memory of a computer for providing a plurality of executable procedures for manipulating information within the database; at least one medical document template for specifying the structure of a respective medical product document, the template including coded references to data for use in the medical product document in accordance with a selected format; and document generation means accessible by the data management user interface for retrieving data objects according to the structure of a medical product document specified within the template, and for arranging the retrieved data objects into the medical product document in a format compatible with the word processor in accordance with the template; wherein the data management user interface is adapted to be co-resident in the executable memory with the word processor to permit operation of the word processor independent of operation of the data management user interface. - View Dependent Claims (18, 19, 20, 21, 22)
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23. A method for producing a document for regulatory review of a medical product, comprising the steps of:
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a) storing data objects pertaining to investigational studies of the medical product in a database; b) retrieving the data objects into an electronic document compatible with a word processor; c) placing delimiter codes in the electronic document for identifying the presence of retrieval data objects in the document and for identifying the corresponding data object location in the database; d) editing the document with the word processor, including the step of editing data objects retrieved into the word processor; e) updating the database to reflect changes made to data objects during said editing step; and f) retrieving edited data objects into the electronic document. - View Dependent Claims (24)
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Specification