Method, system, and software for electronic data capture and data analysis of clinical databases

• US 20050228817A1
• Filed: 10/25/2004
• Published: 10/13/2005
• Est. Priority Date: 10/24/2003
• Status: Abandoned Application

• Current Assignee: Prosanos Corp. (The Cigna Group)
• Original Assignee: Prosanos Corp. (The Cigna Group)
• Inventors: Morris, Jonathan, Reisinger, Stephanie, Hochberg, Alan
• Application Number:
  US10/971,701
• Publication Number:
  US 20050228817A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

A method, system, and software for providing clinical data for analysis. purposes, includes storing clinical data, received from one or more data source sites, in a data repository. On receiving a request for data from the data repository from a user at a data source site, a working set of data is created responsive to the request from the user, and the user is provided access to the working set for analysis purposes. The working set of data is created such that at least some of the data in the working set is unchanged while the analysis is performed even if the data repository is updated while the analysis is performed, and working set only includes restricted data from other data source sites other than the data source site of the user.

Claims

1. A computer implemented method of providing clinical data for analysis purposes, comprising:

storing clinical data, received from one or more data source sites, in a data repository;

receiving a request for data from the data repository from a user at a data source site;

creating a working set of data responsive to the request from the user; and

providing the user access to the working set for analysis purposes,

wherein the working set of data is created such that at least some of the data in the working set is unchanged while the analysis is performed even if the data repository is updated while the analysis is performed, and

wherein the working set only includes restricted data from other data source sites other than the data source site of the user.

2. The computer implemented method according to claim 1, wherein the step of storing the clinical data comprises storing the data in a quarantine database and updating a main database from the quarantine database after a review of the data in the quarantine database.

3. The computer implemented method according to claim 1, wherein the step of storing the clinical data comprises edit checks on data entered from a terminal or received from an external source, and updating access control information related to any data received from a data source site.

4. The computer implemented method according to claim 1, wherein the step of creating a working set of data comprises copying records from the main database to a working set database.

5. The computer implemented method according to claim 1, wherein the step of creating a working set comprises maintaining a transaction database that includes a date and time stamp for each transaction and a working set date and time stamp database that includes the start and/or end date and time stamp for each working set.

6. The computer implemented method according to claim 1, wherein the step of providing the user access to the working set comprises providing access to detail records only from the data source site associated with user while providing restricted access to data from any other data source site.

7. The computer implemented method according to claim 6, wherein the restricted access comprises removing fields from each data record provided to the user.

8. The computer implemented method according to claim 6, wherein the restricted access comprises providing aggregate data derived from aggregating individual data records rather than providing individual data records themselves.

9. The computer implemented method according to claim 6, wherein the restricted access further comprises not providing any individual data record information if the number of individual data records is less than a predetermined number.

10. The computer implemented method according to claim 1, wherein the number of records from other data source sites included in the working set is related to the number of data records provided by the data source site to the data repository.

11. The computer implemented method according to claim 10, wherein the number of records from other data source sites included in the working set is directly proportional to the number of data records provided by the data source to the data repository.

13. The system according to claim 11, wherein the data repository further comprises:

a main database to store data received from each of the data source sites; and

actual working set database that contains the data records for each working set copied from the main database.

15. The system according to claim 13, wherein the data repository further comprises a quarantine database that temporarily stores data records received from data source sites before they are updated on the main database after being reviewed.

12. A system for providing clinical data for analysis purposes, comprising:

one or more data source sites that provide clinical data;

a data repository that receives and stores data received from the one or more data source sites; and

said data repository comprising;

a working set management unit that creates a working set of data responsive to a request from a user at a data source site; and

a user access management unit that determines which data could be included in a working set of data based on the user making the request and the data source site associated with the user;

wherein the working set management unit is configured to ensure that at least some of the data in the working set is unchanged while analysis is performed even if the data repository is updated while the analysis is performed, and

wherein the working set management unit receives input from the user access management unit to create the working set to only include restricted data from other data source sites other than the data source site associated with the user.

14. The system according to claim 12, wherein the data repository further comprises:

a transaction database that contains all transaction records, the transaction records including a date and time stamp of the transaction;

a virtual working set database which comprises a start and/or an end date and time stamp for each working set,

wherein the working set management unit creates the data for a working set with reference to the start and/or end date and time stamps for that working set and retrieving transaction records from the transaction database based on a comparison of the date and time stamps of the transactions to the start and/or the end date and time stamps of the working set.

16. The system according to claim 12, wherein the user access management unit only allows a user access to detail records originating from the data source site associated with the user while allowing the user restricted access to data originating from other data source sites.

17. The system according to claim 16, wherein the user access management unit allows restricted access to data by removing certain fields from each data record that may be included in a working set.

18. The system according to according to claim 16, wherein the user access management unit allows restricted access to data by only allowing access to aggregate data derived by aggregating individual data records rather than allowing access to the individual data records themselves.

19. The system according to claim 16, wherein the user access management unit allows restricted access to data by not providing any individual data record information if the number of individual data records in less than a predetermined number.

20. A computer readable medium having computer program code recorded thereon that, when executed on a computing system, provides clinical data for analysis purposes, the program code comprising:

code for storing clinical data, received from one or more data source sites, in a data repository;

code for receiving a request for data from the data repository from a user at a data source site;

code for creating a working set of data responsive to the request from the user; and

code for providing the user access to the working set for analysis purposes,

wherein the working set of data is created such that at least some of the data in the working set is unchanged while the analysis is performed even if the data repository is updated while the analysis is performed, and

wherein the working set only includes restricted data from other data source sites other than the data source site of the user.

21. The computer readable medium according to claim 20, code for creating a working set of data comprises code for copying records from a main database to working set database.

22. The computer readable medium according to claim 20, wherein the code for creating a working set of data comprises code for updating a transaction database that includes a date and time stamp for each transaction and code for updating a working set database with a start and/or end date and time stamp for each working set.

23. A method of analyzing data from a clinical database comprising:

sending data from a data source site to a data repository for storage at the data storage site;

sending a request for data by a user at the data source site to the data repository; and

receiving access to a working set of data responsive to the request for data, wherein the data repository creates the working set of data such that at least some of the data in the working set is unchanged while the analysis is performed even if the data repository is updated and wherein the working set only includes restricted data from data source sites other than the data source site of the user.