Software architecture and system for performing validated clinical studies of pharmaceutical related products
First Claim
1. A system for performing validated clinical studies of drug-type products, which comprises:
- at least one computer-readable storage medium;
software stored on said at least one computer-readable storage medium, said software being sufficient software to support the following steps;
(a) creating a plurality of data collection documents that includes a plurality of diverse types of data collection documents and a plurality of each diverse type of data collection document, wherein every individual data collection document is provided its own unique identifier;
(b) providing a local system with operator security by having all operators and other data collectors and data handlers, complete identification verification before being permitted to proceed to add information into said local system utilizing said plurality of data collection documents;
(c) having appropriate operators who have successfully completed operator security fill out and sign specified data collection documents for step (a) above, where required;
(d) creating a permanent record of all filled out and signed data collection documents from step (c) and organizing and tracking said filled out and signed documents by their unique identifiers in said local system;
(e) providing a central system functionally connected to said local system, and uploading said permanent record to said central system;
(f) independently reviewing the originally filled out and signed data collection documents to accept said documents as clean or to require clarifications, and keeping a permanent record of all originally filled out and signed documents, with no access for the operators to change or eliminate data;
(g) as to said documents requiring clarifications, making clarification requests to the appropriate operator, and procuring response therefrom;
(h) independently reviewing each response in the form of a revised document, assigning a new unique identifier link to each version of every revised document and every subsequent version thereof, and repeating step (f) above iteratively until said documents are clean, and storing and tracking every version of every document in said central system;
(i) procuring relevant external clinical documents where data were first recorded, said external clinical documents being selected from the group consisting of clinical notes, patient record form entries, laboratory results, and combinations thereof, having the operators input said external clinical documents into said local system;
(j) providing another level of independent data cleaning, source validation, reconciliation, identifications and storage through a monitor query system of communications between monitors and operators that includes the same procedures as set forth in steps (f), (g) and (h) above;
(k) providing a document entry history to the local system and the central system of all changes to all documents within said central system to create an audit trail;
(l) fully securing the audit trail as it is created so that it cannot ever be altered; and
,(m) rendering the finished, clean, final version of each document, as fully secured document that is a read-only document.
1 Assignment
0 Petitions
Accused Products
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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Citations
20 Claims
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1. A system for performing validated clinical studies of drug-type products, which comprises:
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at least one computer-readable storage medium; software stored on said at least one computer-readable storage medium, said software being sufficient software to support the following steps; (a) creating a plurality of data collection documents that includes a plurality of diverse types of data collection documents and a plurality of each diverse type of data collection document, wherein every individual data collection document is provided its own unique identifier; (b) providing a local system with operator security by having all operators and other data collectors and data handlers, complete identification verification before being permitted to proceed to add information into said local system utilizing said plurality of data collection documents; (c) having appropriate operators who have successfully completed operator security fill out and sign specified data collection documents for step (a) above, where required; (d) creating a permanent record of all filled out and signed data collection documents from step (c) and organizing and tracking said filled out and signed documents by their unique identifiers in said local system; (e) providing a central system functionally connected to said local system, and uploading said permanent record to said central system; (f) independently reviewing the originally filled out and signed data collection documents to accept said documents as clean or to require clarifications, and keeping a permanent record of all originally filled out and signed documents, with no access for the operators to change or eliminate data; (g) as to said documents requiring clarifications, making clarification requests to the appropriate operator, and procuring response therefrom; (h) independently reviewing each response in the form of a revised document, assigning a new unique identifier link to each version of every revised document and every subsequent version thereof, and repeating step (f) above iteratively until said documents are clean, and storing and tracking every version of every document in said central system; (i) procuring relevant external clinical documents where data were first recorded, said external clinical documents being selected from the group consisting of clinical notes, patient record form entries, laboratory results, and combinations thereof, having the operators input said external clinical documents into said local system; (j) providing another level of independent data cleaning, source validation, reconciliation, identifications and storage through a monitor query system of communications between monitors and operators that includes the same procedures as set forth in steps (f), (g) and (h) above; (k) providing a document entry history to the local system and the central system of all changes to all documents within said central system to create an audit trail; (l) fully securing the audit trail as it is created so that it cannot ever be altered; and
,(m) rendering the finished, clean, final version of each document, as fully secured document that is a read-only document. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A master system for performing validated clinical studies of drug-type products, which comprises:
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A.) a central system connected to plurality of diversely located local systems, said central system including at least one host computer; B.) a plurality of diversely located local system, each local system having at least one computer functionally connected to said central system at least one host computer; and
,C.) sufficient software to support the following steps; (a) creating a plurality of data collection documents that includes a plurality of diverse types of data collection documents and a plurality of each diverse type of data collection document, wherein every individual data collection document is provided its own unique identifier; (b) providing a local system with operator security by having all operators and other data collectors and data handlers, complete identification verification before being permitted to proceed to add information into said local system utilizing said plurality of data collection documents; (c) having appropriate operators who have successfully completed operator security fill out and sign specified data collection documents for step (a) above, where required; (d) creating a permanent record of all filled out and signed data collection documents from step (c) and organizing and tracking said filled out and signed documents by their unique identifiers in said local system; (e) providing a central system functionally connected to said local system, and uploading said permanent record to said central system; (f) independently reviewing the originally filled out and signed data collection documents to accept said documents as clean or to require clarifications, and keeping a permanent record of all originally filled out and signed documents, with no access for the operators to change or eliminate data; (g) as to said documents requiring clarifications, making clarification requests to the appropriate operator, and procuring response therefrom; (h) independently reviewing each response in the form of a revised document, assigning a new unique identifier link to each version of every revised document and every subsequent version thereof, and repeating step (f) above iteratively until said documents are clean, and storing and tracking every version of every document in said central system; (i) procuring relevant external clinical documents where data were first recorded, said external clinical documents being selected from the group consisting of clinical notes, patient record form entries, laboratory results, and combinations thereof, having the operators input said external clinical documents into said local system; (j) providing another level of independent data cleaning, source validation, reconciliation, identifications and storage through a monitor query system of communications between monitors and operators that includes the same procedures as set forth in steps (f), (g) and (h) above; (k) providing a document entry history to the local system and the central system of all changes to all documents within said central system to create an audit trail; (l) fully securing the audit trail as it is created so that it cannot ever be altered; and
,(m) rendering the finished, clean, final version of each document, as fully secured document that is a read-only document. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification