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System and method for bridging a clinical remote data entry product to a back-end clinical data management system

6556999

Abstract

A back-end clinical definition is designed using a back-end clinical data management system (CDMS). The back-end clinical definition is automatically converted into a Remote Data Entry (front-end) study definition. The front-end study definition is transferred to a remote computer hosting a front-end RDE product where it is used to regulate the acquisition of clinical data. During the back-end clinical definition to front-end study definition conversion process, a conversion map is created. The conversion map allows for the automated conversion of clinical data acquired using the front-end RDE product to a format that can be read by the back-end CDMS. Clinical data is retrieved from remote computers hosting a front-end RDE product in an automated manner without manual back-end clinical definition/front-end study definition conflict resolution.


Claims

We claim:

1. A method for defining a front-end study definition based on a back-end clinical definition, comprising:

creating a conversion map for matching a set of first components in said back-end clinical definition with a set of second components in said front-end study definition; and

parsing each said first component in said set of first components in said back-end clinical definition, wherein, for each said first component in said set of first components, said parsing step comprises:

(i) adding an identifier to said conversion map that corresponds to said first component;

(ii) editing said front-end study definition to include a second component that corresponds to said first component; and

(iii) revising said conversion map to include the identity of said second component in said front-end study definition that corresponds with said first component; wherein

when said parsing step is completed, said conversion map includes a record of matching first and second components in said back-end clinical definition and said corresponding front-end study definition.

2. The method of claim 1 wherein said back-end study definition is an Oracle Clinical definition.

3. The method of claim 1 wherein said front-end study definition is a macro study definition.

4. A computer readable memory used to direct a client/server system to function in a specified manner, comprising:

a back-end clinical data management system (CDMS), said back-end CDMS capable of saving data in accordance with a back-end clinical definition;

a remote data entry module for collecting clinical data in accordance with a front-end study definition; and

a mapper server module for converting said back-end clinical definition into a corresponding front-end study definition, said study definition module including executable instructions stored in said computer readable memory, said executable instructions including:

instructions for creating a conversion map that matches a set of first components in said back-end clinical definition with a set of second components in said corresponding front-end study definition; and

instructions for parsing each said first component in said set of first components in said back-end clinical definition, wherein, for each said first component in said set of first components, said instructions for parsing comprise:

(i) instructions for adding an identifier to said conversion map that corresponds to said first component;

(ii) instructions for editing said corresponding front-end study definition to include a second component that corresponds to said first component; and

(iii) instructions for revising said conversion map to include the identity of said second component in said front-end study definition that corresponds with said first component; wherein

when said instructions for parsing are completed, said conversion map includes a record of matching first and second components in said back-end clinical definition and said corresponding front-end study definition.

5. The computer readable memory of claim 4 wherein said back-end study definition is an Oracle Clinical definition.

6. The computer readable memory of claim 4 wherein said front-end study definition is a macro study definition.

7. A computer program product for use in conjunction with a computer having a processor,

said computer program product comprising a computer readable storage medium and a computer program mechanism embedded therein, the computer program mechanism for defining a front-end study definition based on a back-end clinical definition, the computer program mechanism causing the processor to execute the steps of:

creating a conversion map for matching a set of first components in said back-end clinical definition with a set of second components in said front-end study definition; and

parsing each said first component in said set of first components in said back-end clinical definition, wherein, for each said first component in said set of first components, said parsing step comprises:

(i) adding an identifier to said conversion map that corresponds to said first component;

(ii) editing said front-end study definition to include a second component that corresponds to said first component; and

(iii) revising said conversion map to include the identity of said second component in said front-end study definition that corresponds with said first component; wherein

when said parsing step is completed, said conversion map includes a record of matching first and second components in said back-end clinical definition and said corresponding front-end study definition.

8. The computer program product of claim 7 wherein said back-end study definition is an Oracle Clinical definition.

9. The computer program product of claim 7 wherein said front-end study definition is a macro study definition.

10. A method for storing clinical data in a back-end clinical data management system (CDMS) in accordance with a back-end clinical definition; the method comprising:

creating a conversion map for matching a set of first components in said back-end clinical definition with a set of second components in a front-end study definition, wherein said front-end study definition is used on a remote data entry module for collecting clinical data;

obtaining a front-end data packet from said remote data entry module that collects said clinical data in accordance with said front-end study definition;

parsing said front-end data packet, wherein, for each patient in said front-end data packet, said parsing step comprises adding front-end study definition/back-end clinical definition match data for said patient to a conversion map;

using said conversion map to construct a back-end data packet; and

uploading said back-end data packet into said back-end database, thereby storing said clinical data in said back-end database in accordance with said back-end clinical definition.

11. The method of claim 10 wherein said parsing step further comprises verifying that clinical identifiers have been set for said patient, wherein, when said clinical identifiers have not been set for said patient, data in said packet associated with said patient is rejected.

12. The method of claim 10 wherein said back-end study definition is an Oracle Clinical definition.

13. The method of claim 10 wherein said front-end study definition is a macro study definition.

14. A computer readable memory used to direct a client/server system to function in a specified manner, comprising:

a back-end clinical data management system (CDMS), said back-end CDMS capable of saving data in accordance with a back-end clinical definition;

a remote data entry module for collecting clinical data in accordance with a front-end study definition; and

a server process module for converting clinical data collected by said remote data entry module into a form that can be stored in said back-end CDMS, said server process module including executable instructions stored in said computer readable memory, said executable instructions including:

instructions for creating a conversion map for matching a set of first components in said back-end clinical definition with a set of second components in said front-end study definition;

instructions for obtaining a front-end data packet from a remote data entry module that collects said clinical data in accordance with a front-end study definition;

instructions for parsing said front-end data packet, wherein, for each patient in said front-end data packet, said parsing step comprises adding front-end study definition/back-end clinical definition match data for said patient to said conversion map;

instructions for using said conversion map to construct a back-end data packet; and

instructions for uploading said back-end data packet into said back-end CDMS.

15. The computer readable memory of claim 14 wherein said instructions for parsing further comprise instructions for verifying that clinical identifiers have been set for said patient, wherein, when said clinical identifiers have not been set for said patient, said instructions for parsing further include instructions for rejecting data in said packet associated with said patient.

16. The computer readable memory of claim 14 wherein said back-end study definition is an Oracle Clinical definition.

17. The computer readable memory of claim 14 wherein said front-end study definition is a macro study definition.

18. A computer program product for use in conjunction with a computer having a processor,

said computer program product comprising a computer readable storage medium and a computer program mechanism embedded therein, the computer program mechanism for storing clinical data in a back-end clinical data management system (CDMS) in accordance with a back-end clinical definition, the computer program mechanism causing the processor to execute the steps of:

instructions for creating a conversion map for matching a set of first components in said back-end clinical definition with a set of second components in a front-end study definition, wherein said front-end study definition is used on a remote data entry module for collecting clinical data;

obtaining a front-end data packet from said remote data entry module that collects said clinical data in accordance with said front-end study definition;

parsing said front-end data packet, wherein, for each patient in said front-end data packet, said parsing step comprises adding front-end study definition/back-end clinical definition match data for said patient to said conversion map;

using said conversion map to construct a back-end data packet; and

uploading said back-end data packet into said back-end database in accordance with said back-end clinical definition.

19. The computer program product of claim 18 wherein said parsing step further comprises verifying that clinical identifiers have been set for said patient, wherein, when said clinical identifiers have not been set for said patient, said parsing step further comprises rejecting data in said packet associated with said patient.

20. The computer program product of claim 18 wherein said back-end study definition is an Oracle Clinical definition.

21. The computer program product of claim 18 wherein said front-end study definition is a macro study definition.


Description

One compact disc that includes a Computer Program Listing Appendix has been submitted in duplicate in the present application. The size of the files contained in the Computer Program Listing Appendix, their date of creation, their time of creation, and their name are found in Table 1 below. In Table 1, each row represents a file or directory. If the row represents a directory, the designation "<DIR>" is provided in column one. If the row represents a file, the size of the file in bytes is provided in column one. Columns two and three respectively represent the date and time of file or directory creation while the fourth column represents the name of the file or directory. 

                             TABLE 1
        Contents of the Computer Program Listing Appendix
    Directory of .backslash.GGB_1.1.46.backslash.com
    <DIR>    June 4, 2001  2:00 p roche
    Directory of .backslash.GGB_1.1.46.backslash.com.backslash.roche
    <DIR>    June 4, 2001  2:00 p rde
    Directory of
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    Directory of
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     46.backslash.com.backslash.roche.backslash.rde.backslash.wip
    <DIR>    June 4, 2001  2:00 p api
    <DIR>    June 4, 2001  2:00 p auditor
    <DIR>    June 4, 2001  2:00 p console
    <DIR>    June 4, 2001  2:00 p dbconnect
    <DIR>    June 4, 2001  2:01 p exec
      9,646    Feb. 2, 2001  3:13 a GetEnv.java
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    <DIR>    June 4, 2001  2:02 p install
    <DIR>    June 4, 2001  2:03 p metamapper
    <DIR>    June 4, 2001  2:03 p ocdata
    <DIR>    June 4, 2001  2:03 p ocmeta
    <DIR>    June 4, 2001  2:04 p peer
    <DIR>    June 4, 2001  2:04 p rdesim
    <DIR>    June 4, 2001  2:05 p rdesvr
    <DIR>    June 4, 2001  2:07 p service
    <DIR>    June 4, 2001  2:07 p storage
    <DIR>    June 4, 2001  2:07 p studysite
    <DIR>    June 4, 2001  2:09 p tester
    <DIR>    June 4, 2001  2:09 p tmdata
    <DIR>    June 4, 2001  2:09 p tmmeta
    <DIR>    June 4, 2001  2:09 p translator
    <DIR>    June 4, 2001  2:10 p util
     16,565    Feb. 5, 2001  6:57 a Wip.java
      2,361    May 11, 2001  2:00 p Wip.properties
      3,344  April 23, 2001  7 29 a WipJUnit.properties
     11,356    May 10, 2001  1 36 a WipJUnitTest.java
      2,197    Feb. 5, 2001  8.32 a WipProperties.java
    <DIR>    June 4, 2001  2:10 p xml
    Directory of
     .backslash.GGB_1.1.
     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.api
     13,673  April 26, 2001  8:56 a AcDbFieldDefn.java
      1,525    Oct. 3, 1999  9:22 p ACDataMgr.java
      9,241  Sept. 23, 2000  1:09 p ACDbRow.java
      5,398   Sept. 7, 2000  6:58 p ACDbTableDefn.java
      2,948    Feb. 6, 2000 12:25 p ACMetaMgr.java
      8,411   Aug. 30, 2000 11:53 a ACMetaMqrTest.java
     27,301   Jan. 25, 2001  6:34 a ACPacket.java
     24,128   Sept. 7, 2000 10:12 p ACPacketMgr.java
      4,051    May 12, 2000 12:39 p ApiUtil.java
      1,767    May 12, 2000 12:39 p FieldIsLesser.java
      1,980    May 12, 2000 12:39 p FieldsAreLesser.java
      1,470   Sept. 2, 1999  9:11 a IWriteable.java
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      8,532    June 7, 2000  1:32 p TableComparison.java
    <DIR>    June 4, 2001  2:00 p tl
    <DIR>    June 4, 2001  2:00 p tm
    Directory of
     .backslash.GGB_1.1.
     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.api
    .backslash.oc
      2,986   June 12, 2000  6:29 p ACOCPacket.java
    Directory of
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    .backslash.ps
                    0 file(s)               0 bytes
    Directory of
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     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.api
    .backslash.tl
                    0 file(s)               0 bytes
    Directory of
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     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.api
    .backslash.tm
     22,090  April 26, 2001  8:56 a ACEdiFileReader.java
     11,395  April 25, 2001  5:53 a ACTMPacket.java
      1,153  April 25, 2000  4:10 p EdiFile.properties
    Directory of
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     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.aud
    itor
     14,657  Sept. 28, 2000  6:47 p AuditorMgr.java
      3,935   Dec. 18, 2000  8:25 a AuditorUtil.java
      6,587   Dec. 19, 2000  5:40 a Differ.java
        457  Sept. 19, 2000 11:54 a IMatcher.java
      6,562  Sept. 19, 2000 11:54 a OCDbField.java
      1,134   Dec. 19, 2000  5:41 a OCDbRow.java
      1,183  Sept. 19, 2000 11:54 a OCDbTable.java
      3,066   Dec. 18, 2000  8:41 a OCPatientDataMgr.java
      5,977   Dec. 18, 2000  8:40 a OCPatientDataPacket.java
      2,613   Dec. 18, 2000  8:27 a OCTables.properties
      3,445  Sept. 19, 2000 11:54 a OCTablesInfoReader.java
     16,923   Dec. 18, 2000  8:37 a PatientAuditor.java
      5,516   Dec. 19, 2000  5:42 a PatientAuditTester.java
        534  Sept. 19, 2000 11:54 a RepeatingQMatcher.java
      2,806   Dec. 19, 2000  5:43 a StringMatcher.java
      5,127   Dec. 27, 2000 10:32 p StudyAudit.java
      2,463  Sept. 28, 2000  3:57 p StudyAuditEvent.java
     36,074  March 29, 2001 11:59 a StudyAuditor.java
        549  Sept. 19, 2000 11:54 a TranslatedValueMatcher.java
    Directory of
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    sole
                    0 file(s)               0 bytes
    Directory of
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     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.dbc
    onnect
      6,941   Oct. 12, 2000  5:07 p ConnectionSet.java
      4,084   Feb. 14, 2001  1:34 a DB.properties
      4,559    May 04, 2001  2:56 a DBConnectMgr.java
      3,056   Feb. 13, 2001  1:54 a DBConnectMgrTest.java
    Directory of
     .backslash.GGB_1.1.
     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.exe
    c
     12,687  April 20, 2001  8:17 a ACExecEvent.java
      3,493   Dec. 19, 2000  5:56 p ActivityEvent.java
     30,392   April 3, 2001  7:35 a ConsoleApi.java
     26,562    May 11, 2001  1:59 p ConsoleApi_Stub.java
      4,644   Dec. 19, 2000  5:56 p ErrorEvent.java
      2,168   Dec. 19, 2000  5:56 p EventIsEarlier.java
      1,863  April 26, 2001  8:56 a Exec.properties
      4,522   Dec. 19, 2000  5:56 p ExecActivator.java
     42,607  April 20, 2001  8:17 a ExecCli.java
     28,335    May 11, 2001  1:59 p ExecCli_Stub.java
      6,751   Dec. 19, 2000  5:56 p ExecFileNode.java
     61,266     May 4, 2001  2:56 a ExecMgr.java
     18,842  April 23, 2001  7:29 a ExecMgrTest.java
      1,997   Dec. 22, 2000  3:02 p HeartbeatEvent.java
      1,333   Dec. 22, 2000  3:02 p IAuthorization.java
     12,068   Jan. 24, 2001  5:09 a IConsoleApi.java
      8,458   Jan. 18, 2001 11:18 a IExecCli.java
      3,575   Dec. 22, 2000  3:02 p IMapExec.java
      1,353   Dec. 22, 2000  3:02 p InvalidDateException.java
      1,153   Dec. 22, 2000  3:02 p InvalidStudyException.java
      1,213   Dec. 22, 2000  3:02 p InvalidStudySiteException.java
     11,739   Dec. 22, 2000  3:02 p LogBook.java
     13,927     May 1, 2001  5:33 a Logon.java
      6,508   Dec. 22, 2000  3:02 p Mailer.java
      8,600   Feb. 13, 2001  7:39 a MapExecApi.java
     11,649    May 11, 2001  1:59 p MapExecApi_Stub.java
      1,785     May 4, 2001  2:56 a OCException.java
      1,072   Dec. 22, 2000  3:02 p PatientMapException.java
      2,403   Dec. 22, 2000  3:02 p PermissioDeniedEvent.java
      2,336   Dec. 22, 2000  3:02 p PermissionGrantedEvent.java
     73,246     May 4, 2001  7:35 a Process.java
      1,196   Dec. 22, 2000  3:02 p ProcessException.java
      5,950   Dec. 22, 2000  3:02 p ProcessStatistic.java
      7,551     May 4, 2001  7:35 a ProcessThread.java
      2,767   Dec. 22, 2000  3:02 p ProcessTimer.java
      1,779   Dec. 22, 2000  3:02 p ServerCommandType.java
      3,458   Dec. 22, 2000  3:02 p ServerPermissionEvent.java
      2,502   Dec. 22, 2000  3:02 p ServerProcessEvent.java
      2,107   Dec. 22, 2000  3:02 p ServerResponseEvent.java
      3,907   Jan. 23, 2001  1:54 a ServerState.java
      3,181   Dec. 22, 2000  3:02 p ServerStatusEvent.java
      4,511   Dec. 22, 2000  3:02 p SilentEvent.java
        649   Oct. 13, 2000 12:21 p StatusAccount.properties
     80,092  April 26, 2001  8:56 a StatusAccountMgr.java
     24,471   Dec. 22, 2000  3:02 p StatusAccountPacket.java
      1,380   Dec. 22, 2000  3:02 p StudyAlreadyExistsException.java
    Directory of
     .backslash.GGB_1.1.
     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.gra
    phics
      7,383   Jan. 31, 2000  5:38 p ACFrame.java
     15,982  April 19, 2000  4:41 p ACFrameVwr.java
        957  Sept. 20, 1999 12:25 p AWTButton.java
      1,961   Feb. 19, 1999 12:04 a BorderFilter.java
     13,936  Sept. 17, 1999  3:58 p BorderPanel.java
      4,515    Jan. 7, 2000  8:32 p FieldEntryDialog.java
      7,335  Sept. 20, 1999 12:25 p GraphButton.java
        922  Sept. 20, 1999 12:25 p IButton.java
      5,491    Jan. 7, 2000  8:32 p LoginDialog.java
      3,787   Jan. 


27, 2000 11:47 a OKDialog.java
      5,494  Sept. 20, 1999 12:25 p PadEdgeFilter.java
      4,804  Sept. 20, 1999 12:25 p PercentLayout.java
      2,937  Sept. 20, 1999 12:25 p ProgressBar.java
      5,560  April 19, 2000  4:41 p PropertiesDialog.java
      4,750  April 19, 2000  4:41 p SelectionDialog.java
      2,524  Sept. 20, 1999 12:25 p SimpleMenu.java
      3,725  Sept. 20, 1999 12:25 p StatusPanel.java
      1,729  Sept. 20, 1999 12:25 p TintFilter.java
      6,939   Aug. 12, 1999  9:42 a WidgetMaker.java
      3,795    Jan. 7, 2000  8:32 p YesNoDialog.java
    Directory of
     .backslash.GGB_1.1.
     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.ins
    tall
      8,703    Jan. 4, 2001  4:28 p ACInstallGui.java
     34,373   Feb. 14, 2001  8:02 a Configurator.java
      2,139    May 11, 2001  6:38 a Install.properties
     24,915  April 13, 2001  5:51 a Installer.java
      6,381    Jan. 4, 2001  4:25 p InstallTest.java
      9,363  March 21, 2001  8:38 a Unjar.java
    Directory of
     .backslash.GGB_1.1.
     46.backslash.com.backslash.roche.backslash.rde.backslash.wip.backslash.met
    amapper
      2,811   Sept. 1, 2000 10:23 a ACMetaElement.java
      1,520    Feb. 5, 2000  1:37 p ACMetaIndex.java
      1,543   Sept. 6, 2000 12:30 p ArezzoVocab.java
      6,391    Dec. 3, 1999 10:00 a DataTypeChooser.java
      5,302  Sept. 20, 1999 12:26 p DciTemplate.java
     20,442    Nov.13, 2000  1:27 p DcmQualifier.java
      2,268   Jan. 12, 2000  6:47 p ECrfCoordinate.java
      2,912  March 22, 2000  5:44 p Formatter.java
     28,105   Jan. 30, 2001  5:39 a GroupRepeater.java
     28,765   Aug. 10, 2000  8:07 p LayoutAdjuster.java
      8,037    Feb. 9, 2001  8:58 a Map.properties
      3,704   Sept. 5, 2000  6:11 p MapException.java
     38,257    Feb. 9, 2001  7:07 a MapMgr.java
     15,100     May 5, 2000  3:16 p MapMgrTest.java
     59,595    May 10, 2001  9:14 a MapUpdater.java
     15,091    Feb. 9, 2001  7:07 a MetaElementRegistry.java
     12,913   Oct. 10, 2000  3:02 p OcClinicalPlannedEvent.java
      4,696     May 7, 2000  3:59 p OcClinicalStudy.java
      3,622   Aug. 10, 2000  8:07 p OcDci.java
      8,809   Aug. 10, 2000  8:07 p OcDcm.java
      9,598    Oct. 9, 2000  7:02 p OcDcmLayout.java
     10,062   Jan. 20, 2000 11:26 a OcDcmLayoutPage.java
      2,734    Oct. 9, 2000  7:02 p OcDcmQuesRepeatDefault.java
     14,001   Dec. 11, 2000  6:35 p OcDcmQuestion.java
      8,282   Aug. 10, 2000  8:07 p OcDcmQuestionGroup.java
      3,299  April 27, 2000  2:11 p OcMetaElement.java
     19,549   Aug. 11, 2000  1:24 p OcMetaIndex.java
      5,443   Aug. 14, 2000 12:53 p OCobjBuilder.java
      1,327    Dec. 5, 1999  8:59 p OcScreenCoordinate.java
     86,744    May 10, 2001  9:14 a OcTmMapper.java
      9,411   Aug. 11, 2000  1:24 p OcTmMetaIndex.java
     31,818   Sept. 3, 2000  6:05 p PromptFinder.java
      8,433   Dec. 11, 2000  6:35 p QuestionDefaulter.java
     73,987  March 29, 2001 11:27 a StudyMap.java
      2,876    Nov. 9, 2000  8:25 p StudyUpdateEvent.java
      8,743   Sept. 3, 2000  4:25 p TmClinicalTrial.java
     20,270   Aug. 30, 2000  4:58 p TmCRFElement.java
     24,489    May 10, 2001  2:39 a TinCRFPage.java
     21,473  April 19, 2001  6:04 a TmDataItem.java
      3,156   Aug. 10, 2000  8:07 p TmEnrollForm.java
      2,168   Aug. 10, 2000  8:07 p TmEnrollvisit.java
      5,191  April 28, 2000  2:08 p TmMetaElement.java
      3,797   Aug. 11, 2000  1:24 p TmMetaIndex.java
     30,070   Sept. 3, 2000  4:25 p TMobjBuilder.java
      5,271   Dec. 27, 2000 10:32 p TmStudyDefinition.java
     10,006   Aug. 10, 2000  8:07 p TmStudyVisit.java
      4,322  April 21, 2000  5:50 p TmStudyVisitCRFpage.java
      3,785   Dec. 27, 2000 10:32 p TmTrialStatusHistory.java
      8,392   Aug. 10, 2000  8:07 p TmValueData.java
      2,879   Aug. 10, 2000  8:07 p TmVisitDateForm.java
      7,880   Aug. 11, 2000  1:24 p WidgetChooser.java
    Directory of
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    ata
      4,948   Dec. 16, 1999  7:05 p com_roche_rde_wip.sub.--
                                    ocdata_DcApi.h
     21,297   Aug. 26, 1999 12:00 p Dcapi.h
     20,519    May 24, 2000  7:13 p DcApi.java
      1,362   Oct. 31, 2000  9:38 p OCData.properties
      1,798    Nov. 9, 2000  8:25 p OCDataEvent.java
      4,806   April 2, 2000  6:16 p OCDataLoadException.java
     29,091    Nov. 9, 2000  8:25 p OCDataMgr.java
      5,653   Aug. 30, 2000 11:53 a OCDataMgrTest.java
     16,663    Nov. 1, 2000 12:45 p OCDataPacket.java
     22,510   Oct. 31, 2000  9:38 p OCDataRecordLoader.java
      7,272   Oct. 31, 2000  9:38 p OCDataTableReader.java
      6,326   Oct. 31, 2000  9:38 p OCDataUtil.java
      4,850   Sept. 5, 2000  9:16 a OcPatientRecordLoader.java
      2,272   April 2, 2000  6:16 p PatientRecord.java
      4,160  Sept. 25, 2000  5:05 p RdciKeysRecord.java
     55,701   Oct. 31, 2000  9:38 p wip_dcapi.c
    Directory of
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    eta
      1,025   Oct. 20, 1999  9:37 a DciJudge.java
      2,718   March 1, 2000  9:48 p OCMeta.properties
      1,825  April 16, 2001  6:37 a OCMetaMgr.java
      7,073   July 10, 2000 11:56 a OCMetaMgrTest.java
      1,735   Nov. 13, 2000  1:27 p OCMetaPacket.java
      7,252  Sept. 15, 2000  3:00 p OCTableReader.java
    Directory of
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    r
     10,628   Feb. 21, 2001  7:10 a ACBot.java
      4,621    Feb. 8, 2001  6:55 a ACPeer.java
      7,612    Feb. 8, 2001  6:55 a ACRmiPeer.java
      5,558   Feb. 21, 2001  7:10 a ACVoyagerPeer.java
      1,009    Feb. 8, 2001  6:55 a IACBot.java
      1,826    Feb. 8, 2001  6:55 a IClient.java
      1,138    Feb. 8, 2001  6:55 a IRdeBot.java
      2,932    Feb. 8, 2001  6:55 a IRmiService.java
        836    Feb. 8, 2001  6:55 a IRmiTestSvr.java
      1,319    Feb. 8, 2001  6:55 a IServer.java
        703    Feb. 8, 2001  6:55 a IVoyagerService.java
        587   Nov. 13, 2000  5:19 p Peer.properties
      2,203    Feb. 8, 2001  6:5S a PeerException.java
     26,269     May 4, 2001  7:35 a RdeBot.java
     10,388    Feb. 8, 2001  6:55 a RdeBotTest.java
      6,178    Feb. 8, 2001  6:55 a RmiActivatableService.java
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      4,604    Feb. 8, 2001  6:55 a RiniClient.java
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      9,057   April 3, 2001  7:43 a RmiService.java
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      3,414    Feb. 2, 2001  7:10 a RmiTest.java
      4,155    Feb. 9, 2001  9:17 a RmiTestClient.java
      3,612    Feb. 9, 2001  9:17 a RmiTestSvr.java
      7,853    May 11, 2001  1:59 p RmiTestSvr_Stub.java
      5,817    Feb. 9, 2001  9:17 a VoyagerClient.java
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      2,762    Nov. 5, 1999  3:15 p ACDataGenerator.java
     14,539    Feb. 5, 2000  1:37 p ACRdesimMgr.java
     13,193    Dec. 1, 1999  5:16 p ConfigHelper.java
     15,429    Nov. 5, 1999  3:15 p OCDataGenerator.java
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      1,921   Oct. 18, 1999  4:55 p RdeSim.properties
     38,522    May 31, 2000  2:05 p RdeSimLsnr.java
     13,204   Aug. 30, 2000 11:53 a RdeSimTest.java
      4,527     May 5, 2000  1:00 p RdeSimuiator.java
     21,252    Oct. 8, 1999  9:04 a RdeSimVwr.java
     19,125    May 31, 2000  2:05 p RdeTMSimMgr.java
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     19,431     May 4, 2001  7:35 a ACMacroApi.java
     16,629    Feb. 2, 2001  7:12 a ACRule.java
      9,985    May 14, 2000  6:22 p ACRuleCrossTableCheck.java
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      3,140   Oct. 18, 2000 10:48 a DBAndFileLock.java
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     11,624   Oct. 18, 2000  4:36 a FileLock.java
        492   May 5,4, 2000  5:56 p ICRFPageDataItemVisitIdRule.
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        463   July 12, 2000  5:05 p IGetRow.java
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        864    May 15, 2000  8:39 a InvalidCheckValuesException.java
        751   July 20, 2000  5:09 p IPageItemVisitCheck.java
        608    May 14, 2000  6:23 p IRule.java
        908   Feb. 11, 2000  2:30 p IStudySiteApi.java
        798   July 20, 2000  5:09 p ITrialVisitPageItemCheck.java
     17,582  April 27, 2001  3:36 a MacroDataApi.java
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      2,361     May 2, 2001  3:47 a RdeActivator.java
        964    Oct. 9, 2000 11:51 a RdeDatabaseLockException.java
        967   July 20, 2000  5:09 p RdeSiteNotFoundException.java
        971   July 20, 2000  5:09 p RdestudyNotFoundException.java
      4,377  April 30, 2001  5:44 a RdeSvr.properties
     43,390     May 4, 2001  7:35 a RdeSvrMgr.java
     45,292    May 11, 2001  1:51 a RdeSvrMgrTest.java
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      1,687    May 11, 2001  1:51 a RdeSvrTest.properties
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    <DIR>    June 4, 2001  2:05 p about
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        424     May 1, 2001  2:51 a Authenticate.properties
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        940   5, 2001, 2001  2:54 a IAuthenticate.java
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      6,217   Dec. 21, 2000  9:48 a RemoveRMIServer.java
      3,595   Dec. 20, 2000  5:01 p Subspace.java
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     18,181   Dec. 20, 2000  5:01 p TableSorter.java
     42,052   Dec. 20, 2000  2:56 p ToolsAccess.java
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      4,443   Nov. 15, 2000  5:18 p AboutData.java
      2,471   Dec. 22, 2000  5:36 p AboutGlassPane.java
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        237   Sept. 1, 2000  3:57 p Console.properties
     45,450  March 30, 2001  3:52 a ConsoleClient.java
      1,337   Dec. 21, 2000  5:37 p ConsoleException.java
     31,750   Jan. 24, 2001  5:53 a ConsoleGUITest.java
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     22,518   Dec. 21, 2000  5:37 p GraphCanvas.java
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      3,489   Dec. 21, 2000  5:37 p MessagePanelTest.java
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     16,180   Feb. 14, 2001  7:50 a PropertyData.java
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     13,716   Feb. 14, 2001  7:54 a PropertyPanel.java
      3,098   Dec. 21, 2000  5:37 p PropertyPanelTest.java
      3,803   Dec. 21, 2000  5:37 p PropertyView.java
      8,450   Dec. 21, 2000  5:37 p RDEMachineComboBoxData.java
     23,708   Jan. 24, 2001  5:52 a ServerAccess.java
      1,024   Sept. 1, 2000  4:24 p StatusData.java
      6,876   Jan. 23, 2001  5:22 a StatusPanel.java
      4,280   Jan. 23, 2001  5:23 a StatusPanelTest.java
      4,604   Dec. 21, 2000  5:37 p StatusView.java
      7,197   Dec. 21, 2000  5:37 p StudyComboBoxData.java
     18,267   Dec. 21, 2000  5:37 p StudyData.java
     11,754   Dec. 21, 2000  5:37 p StudyPanel.java
      2,797   Dec. 21, 2000  5:37 p StudyPanelTest.java
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      1,601  March 23, 2000  3:03 p AppSvr.java
      1,214   Oct. 26, 2000 12:26 p ExecClnt.java
      2,835  April 21, 2000  1:36 p ExecSvr.java
        240   April 5, 2000  4:03 p ExecSvr.properties
      7,859    May 11, 2001  1:59 p ExecSvr_Stub.java
        219  March 23, 2000  2:57 p IExecSvr.java
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     19,720   Dec. 22, 2000  5:37 p ConfigurePaneljava
      4,366   Dec. 22, 2000  5:37 p ConfigureView.java
     11,560   Dec. 22, 2000  5:37 p CRFDataItem.java
     18,709   Dec. 22, 2000  5:37 p CRFElement.java
     18,262   Dec. 22, 2000  5:37 p CRFPainter.java
     14,594   Dec. 22, 2000  5:37 p IMap.java
     18,788   Dec. 22, 2000  5:39 p MapActivator.java
     28,315    May 11, 2001  1:59 p MapActivator_Stub.java
     36,599    Jan. 3, 2001 11:01 a MapClient.java
    117,659     May 4, 2001  8:19 a MapServer.java
        672    July 7, 2000 10:31 a MapServer.properties
     30,701     May 4, 2001  8:10 a MapServerAccess.java
     28,599   Dec. 22, 2000  5:37 p MapServerTest.java
     27,643    May 11, 2001  1:59 p MapServer_Stub.java
        135    June 1, 2000  8:20 a MapUser.properties
      9,422   Dec. 22, 2000  5:37 p PropertyNode.java
     18,202   Dec. 22, 2000  5:37 p StudyChooser.java
     20,123     May 4, 2001  8:11 a StudyChooserData.java
      8,175   Dec. 22, 2000  5:37 p StudyChooserView.java
     20,392     May 4, 2001  8:11 a StudyData.java
     24,792   Dec. 22, 2000  5:37 p StudyPanel.java
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      3,201    June 7, 2000  1:35 p EventRange.java
     70,277   Feb. 14, 2001  5:19 a GgbTableRdr.java
     10,814   Oct. 24, 2000 12:44 p Storage.properties
     32,884   Jan. 19, 2001  4:13 p StorageMgr.java
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      6,522   April 4, 2001  7:40 a DciQualReader.java
      2,551   Jan. 30, 2000  5:14 p OcDesignElement.java
      5,340    Feb. 5, 2000  1:37 p OcInvestigator.java
      8,971  April 16, 2001  8:45 a OcPatient.java
      6,966  April 16, 2001  8:45 a OcSite.java
     39,001  April 21, 2001  7:15 a OCStudySiteTableReader.java
     40,462   April 9, 2001  9:21 a PatientMapper.java
      2,612   July 14, 2000 12:39 p StudySite.properties
      3,170    Nov. 9, 2000  8:25 p StudySiteEvent.java
     33,289  April 21, 2001  7:15 a StudySiteMgr.java
     10,452   Aug. 30, 2000 11:53 a StudySiteMgrTest.java
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     12,851   July 10, 2000 11:56 a ACWipTestLsnr.java
     19,258   July 10, 2000 11:56 a ACWipTestMgr.java
     20,487   Dec. 22, 1999  7:01 p ACWipTestVwr.java
    <DIR>    June 4, 2001  2:07 p api
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      8,778  April 18, 2000 11:31 a WipTester.java
     14,784   Jan. 17, 2000  9:44 a WipTestLsnr.java
     28,576   Jan. 17, 2000  5:42 p WipTestLsnrDataTMtooc.java
     26,409   Jan. 25, 2000  5:45 p WipTestLsnrMetaOctoTM.java
      9,012   Jan. 27, 2000 10:25 a WipTestMgr.java
     20,235   Feb. 29, 2000  4:55 p WipTestMgrDataTMtoOC.java
     15,600   March 8, 2000  1:42 p WipTestMgrMetaOCtoTM.java
      6,412   Dec. 21, 1999  5:12 p WipTestVwr.java
      8,242   Jan. 14, 2000  5:10 p WipTestVwrDataTMtoOC.java
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      4,283    May 18, 2000  1:00 p ApiTester.java
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      3,072     May 8, 2000  8:02 p CRFInspectorVwr.java
      5,898     May 8, 2000  8:02 p DcmlayInspectorVwr.java
      4,572   Feb. 13, 2001  1:35 p MapTester.java
     50,590  April 16, 2001  8:15 a MapTestLsnr.java
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      3,635   Dec. 18, 2000  8:56 a DifferencesFrame.java
      1,923   Dec. 18, 2000  8:42 a IAuditLabels.java
     10,167   Dec. 18, 2000  8:54 a Patient.java
     20,451   Dec. 18, 2000  8:45 a PatientAuditLsnr.java
     17,647   Dec. 18, 2000  9:25 a PatientAuditModel.java
      1,212   Dec. 18, 2000  8:54 a PatientAuditTester.java
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      3,336  April 10, 2001  6:47 a DataTester.java
     20,750  April 26, 2001  8:56 a DataTestLsnr.java
     11,016  April 26, 2001  8:56 a DataTestVwr.java
      3,373    May 18, 2000  1:00 p PeerTester.java
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      2,821    Oct. 1, 2000  3:59 p DateConverter.java
     11,871   Dec. 27, 2000 10:32 p DateConvertLsnr.java
      5,532    Oct. 1, 2000  5:21 p DateConvertVwr.java
      5,444   Feb. 23, 2001  8:19 a ImportTimeVwr.java
      2,058   Aug. 30, 2000 11:53 a RdeSvrTest.java
        665    Nov. 8, 2000  1:25 p RdeSvrTest.properties
      1,268   Nov. 28, 2000  3:52 a RdeTester.java
     31,090     May 1, 2001  5:53 a RdeTestLsnr.java
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      3,514   July 21, 2000  2:37 p RmiPeerTester.java
      5,910   July 21, 2000  2:37 p RmiPeerTestLsnr.java
      8,873  April 13, 2000 11:01 a RmiPeerTestvwr.java
      4,085   July 21, 2000  2:37 p TestcInt.java
      3,554   July 21, 2000  2:37 p TestSvr.java
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      2,941    May 18, 2000  1:00 p StorageTester.java
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     16,117  April 25, 2001  5:53 a TMData.properties
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     15,574  Sept. 12, 2000 12:34 p TMMetaMgr.java
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      3,292   Dec. 13, 1999  9:22 a CannotComputeException.java
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      3,886  March 22, 2000  2:44 p ConstantFcn.java
     15,145  Sept. 15, 2000  7:51 p FcnInterpreter.java
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      3,046   Dec. 12, 1999  6:26 p FormatFcn.java
      1,214   Dec. 12, 1999  6:26 p IFcn.java
      5,802   Sept. 8, 2000 12:11 p MapFcn.java
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     51,098   March 5, 2001 12:40 a TmOcTranslator.java
      3,579   Dec. 12, 1999  6:26 p TokenizeFcn.java
      2,283  April 10, 2000 11:44 a ToUpperFcn.java
        706   Dec. 20, 2000  4:20 p Trans.properties
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The Computer Program Listing Appendix disclosed in Table 1 is hereby incorporated by reference.

FIELD OF THE INVENTION

This invention relates generally to a software program and method that converts a back-end clinical definition, defining a data structure and legacy data entry forms for data entry into a clinical data management system, to a front-end study definition. The front-end study definition includes a set of forms used by a Remote.

Data Entry (RDE) application to collect clinical data. The present invention further includes a method and apparatus for retrieving clinical data from RDE applications and feeding the data, on an automated basis, to the back-end clinical data management system.

BACKGROUND OF THE INVENTION

Before a new drug may be sold in many countries of the world, regulatory approval must be granted. One of the most expensive and difficult aspects of obtaining this regulatory approval is the presentation of statistically significant data from clinical trials. Typically, clinical trials used to support a new drug application are divided into three or more phases, the most prominent of which are phases I, II, and III.

Phase I studies are primarily concerned with assessing the safety of a drug. Phase I testing in humans is typically done in about 20 to 100 healthy volunteers. A phase I clinical study is designed to determine what happens to the drug in the patient. That is, how it is absorbed, metabolized, and excreted. In addition, by measuring the side effects of the drug at various dosage levels, a phase I study provides information on optimal drug dosage.

While a phase I study is directed to drug safety, a phase II clinical trial is directed to drug efficacy. A phase II study occurs after successful completion of a phase I study. A phase II clinical study may last from several months to two years, and involve up to several hundred patients at numerous clinical sites throughout the world. Most phase II studies are randomized trials. One group of patients receives the experimental drug while a control group receives a placebo. Often phase II studies are "blinded" in the sense that neither the patients nor the researchers know who is getting the experimental drug. In this manner, the phase II study can provide a pharmaceutical company and a regulatory body, such as the United States Food and Drug Administration (FDA) of the United States or the European Commission (EC) of the European Union, comparative information about the efficacy of the new drug. If the phase II study is successful, a phase III study may be authorized.

Typically, in a phase III study, the new drug is tested in several hundred to several thousand patients at hundreds of clinical sites throughout the world. This large-scale testing provides the pharmaceutical company and the regulatory agency with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Once a phase III study is successfully completed, a pharmaceutical company can request regulatory approval for marketing the new drug.

The resources needed to support a complex multi-site phase II or phase III clinical are staggering. Trained professionals must administer the new drug under the exact requirements of the protocols of the clinical study and intricate patient records must be maintained. The clinical trial protocol may require numerous patient visits over an extended period of time. Any error in the patient record could result in patient data disqualification.

Because of the complexity of the protocols used in clinical trials, the amount of information that must be tracked requires the capabilities of a back-end clinical data management system (CDMS). Representative back-end clinical data management systems include Clintrial 4.3, (Clinsoft Corporation, Lexington, Mass., www.clinsoft.net), and Oracle Clinical (O/C), Oracle Inc., Redwood Shores, Calif., www.oracle.com). These back-end clinical data management systems typically provide sophisticated tools such as, a batch validation engine, a batch data loader, a randomization system, a thesaurus management system, and a lab reference range system. However, because a clinical trial may be conducted at hundreds of sites throughout the world, it is impracticable to place a back-end CDMS at each clinical site. The problem of routing clinical data into a back-end CDMS has therefore been addressed by a number of different approaches in the art.

A traditional approach to routing clinical data to a back-end CDMS is to gather clinical data at each site using paper-based forms designed in accordance with the specifications of a clinical trial. At a later date, the paper-based forms are manually entered twice into a computer. This double-entry is requested in order to compare the two data sets in order to check for data entry errors. While this approach is functional, it is unsatisfactory. Electronic data entry based on the paper-based forms is often done at a site that is remote from the clinical setting, making it difficult to consult the clinician if there is a problem with the content of the paper-based forms. Because of the exact requirements of the clinical trial protocol, such unresolved errors typically result in patient disqualification. Another problem with paper-based forms is that the information is essentially processed twice, first, when the data is entered on the paper-based form and, second, when the electronic data entry is done based on the content of the paper-base forms. This effectively doubles the chance of error in the data entry process. Yet another problem with paper based forms is that there is considerable delay before the clinical data is available is review because a sponsor needs to wait until the clinical data is entered into the back-end database before electronic analysis may be run on the clinical data.

To address the problems with traditional approaches to clinical data entry into a legacy CDMS, an entire industry of Remote Data Entry (RDE) products has developed. Representative vendors in this industry include InferMed, Ltd., London UK, (www.infermed.com), Phase Forward Inc., Waltham, Mass., (www.phaseforward.com), CB Technology, Philadelphia, Pa., (www.cbtech.com), DataTRAK Cleveland, Ohio, (www.datatraknet.com), and Araccel, Stockholm, Sweden, (www.araccel.com), and TEAMworks, Hannover, Germany (www.teamworks.de). These RDE products are also termed front-end data acquisition products. RDE products provide capabilities for making electronic clinical data entry forms that are used on a client computer, such as a laptop, at the clinical site. Data collected using an RDE product are sent electronically to a centralized back-end CDMS where statistical analysis is performed on the clinical data to ascertain drug efficacy and/or safety.

RDE products are advantageous because they prevent discrepancies during data entry. An RDE product provides electronic case report forms (eCRFs) to the data entrant for entry of clinical data. The eCRF is capable of containing data validation checks that show a warning in the case when incorrect or "out of the programmed range" entries are received. The data entrant can then correct the problem with the data entry immediately. In addition the eCRF provides "protocol guidance." For example, pregnancy test questions are only displayed to the data entrant when the patient has indicated that she is female.

While RDE products represent an advance over the paper-based form approach, they are unsatisfactory. RDE products require a custom study definition to be prepared for each clinical trial. For example, MACRO from InferMed, Ltd., London UK, requires that a macro study definition be prepared for each clinical trial monitored by MACRO. The macro study definition is a collection of metatables that describe the patient data collected at a clinical site. The macro study definition may also include the format of the electronic forms used to acquire the clinical data as well as other pertinent data acquisition components.

In the art, a clinical definition must be set up for the back-end CDMS. The back-end clinical definition is a data structure that is used to track all the patients in a clinical study. The back-end clinical definition is designed in accordance with the specifications of the particular back-end CDMS used to support a particular clinical study. The problem with the RDE custom study definitions and the back-end clinical definitions becomes apparent when one tries to interface the RDE custom study definition to the back-end clinical definition. Because there are no industry standards for RDE study definitions and back-end clinical definitions, significant custom programming is needed for each clinical study, in order to allow an RDE system to electronically feed data to a back-end CDMS.

A third approach to addressing the problem of clinical data entry is to provide a web page interface to a back-end CDMS. An example of a product that uses this approach is Oracle Clinical Remote Data Capture v4i, Oracle Inc., Redwood Shores, Calif. In this approach, each clinical site includes a client computer with a standard web browser. The web browser is used to load into the client computer a data entry form from a remote web server. Clinical data are then entered into the data entry form. Advantageously, the data entered into the web-based data entry form may be electronically entered directly into the back-end CDMS. While the third approach eliminates the need to interface a front-end study definition with a back-end clinical definition, this approach is still unsatisfactory. First, the client computer must be connected to the back-end CDMS by a long-distance network throughout data entry. This requirement limits how the web page interface may be constructed and deployed. Another disadvantage to using a long-distance network throughout data entry are the issues of network latency, network bandwidth limitations, and server load that are inevitably raised. These issues conspire to make data entry a frustrating experience. In fact, it is widely appreciated that data entry using a web page driven by a remote server requires tremendous patience. For example, consider the amount of patience required to enter personal data at an Internet web site, such as www.amazon.com, in order to register at the site. Clinical data entry using a web page system, such as Oracle Clinical Remote Data Capture v4i, is comparable to registering hundreds to thousands of people at a site such as www.amazaon.com or www.gap.com on a periodic basis over an extended period of time.

Yet another disadvantage of using a web page interface to a back-end CDMS is that back-end CDMS interfaces are designed for data-entry clerks. Therefore, they lack support for the tools necessary to ensure that clinical trial protocol is followed. Such tools include protocol violation alerts, enforced eligibility, and protocol recommendations regarding dosing or test procedures. Furthermore, direct data entry into a back-end CDMS using a web-page introduces questionable practices. Back-end CDMS interfaces are designed to facilitate data entry by data-entry clerks. As such, many of the fields in the data entry forms have defaulted answers. While the use of defaulted answers is appropriate for routine data-entry, it is not appropriate for forms that are considered source documents. A source document represents the form that records actual clinical observations. In order to ensure that all clinical observations mandated by a clinical protocol are actually made, the source form should not have defaulted answers.

In view of these difficulties, what is needed in the art is a system and method for collecting clinical data without the many drawbacks found in preexisting systems and methods.

SUMMARY OF THE INVENTION

The present invention provides novel solutions to the drawbacks found in the art. In particular, the present invention uses a back-end clinical definition developed in accordance with a legacy back-end CDMS to generate a set of forms, also termed a front-end study definition, that can be used by a front-end Remote Data Entry (RDE) product. A clinical worker designs a back-end clinical definition using a back-end CDMS. Then, using the instant invention, the back-end clinical definition is converted into a front-end study definition. The front-end study definition is transferred to each computer hosting a front-end data RDE product in a clinical trial. The front-end RDE product uses the front-end study definition to regulate the acquisition of clinical data. The front-end study definition includes the description of a set of forms that are used by a data entrant to enter clinical data.

During the process of converting a back-end clinical definition to a front-end study definition, a novel conversion map is created. The conversion map allows for the conversion of clinical data acquired with the RDE product to a format that can be electronically read by a back-end CDMS. In one embodiment of the present invention, clinical data acquired using the front-end RDE product is converted into a novel front-end data packet that can be electronically imported into the legacy back-end CDMS. In this way, data can be acquired without independently creating a back-end clinical definition and a front-end study definition and tediously resolving conflicts between the two definitions. Furthermore, the instant invention allows front-end data to be acquired in real-time without the use of time consuming Internet driven menus that attempt to pipe data directly into a back-end CDMS over the Internet using web page-based data entry screens.

One aspect of the present invention provides a method for defining a front-end study definition based on a back-end clinical definition. In the method, a conversion map is created for matching a set of first components in the back-end clinical definition with a set of second components in the front-end study definition. Each of the first components in the set of first components in the back-end clinical definition is parsed. This parsing step involves: (i) adding an identifier to the conversion map that corresponds to the first component, (ii) editing the front-end study definition to include a second component that corresponds to the first component and, (iii) revising the conversion map to include the identity of the second component in the front-end study definition that corresponds with the first component. When the parsing step is completed, the conversion map includes a record of matching first and second components in the back-end clinical definition and the corresponding front-end study definition. In one embodiment of the present invention the back-end study definition is an Oracle Clinical definition and the front-end study definition is a macro study definition.

Another aspect of the present invention provides a computer readable memory that is used to direct a client/server system to function in a specified manner. The computer readable memory includes a back-end CDMS that is capable of saving data in accordance with a back-end clinical definition. The memory further includes a Remote Data Entry module for collecting clinical data in accordance with a front-end study definition. The memory also includes a mapper server module for converting the back-end clinical definition into a corresponding front-end study definition. The study definition module includes executable instructions stored in the computer readable memory that include:

instructions for creating a conversion map that matches a set of first components in the back-end clinical definition with a set of second components in the corresponding front-end study definition; and

instructions for parsing each of the first components in the set of first components in the back-end clinical definition, wherein, for each of these first components in the set of first components, the instructions for parsing comprise:

(i) instructions for adding an identifier to the conversion map that corresponds to the first component;

(ii) instructions for editing the corresponding front-end study definition to include a second component that corresponds to the first component; and

(iii) instructions for revising the conversion map to include the identity of the second component in the front-end study definition that corresponds with the first component.

When the instructions for parsing are completed, the conversion map includes a record of matching first and second components in the back-end clinical definition and the corresponding front-end study definition.

Yet another aspect of the present invention provides a method for storing clinical data in a back-end CDMS in accordance with a back-end clinical definition. In this method, a front-end data packet is obtained from a Remote Data Entry module. The Remote Data Entry module collects the clinical data in accordance with a front-end study definition. Then the front-end data packet is parsed. For each patient in the front-end data packet, this parsing step comprises adding front-end study definition/back-end clinical definition match data for the patient to a conversion map. Once all the patients are parsed, the conversion map is used to construct a back-end data packet that is uploaded to the back-end CDMS. In some embodiments, the parsing step further comprises verifying that clinical identifiers have been set for the patient, wherein, when the clinical identifiers have not been set for said patient, data in the front-end data packet associated with the patient is rejected. In some embodiments of the present invention, the back-end study definition is an Oracle Clinical definition and the front-end study definition is a macro study definition.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional objects and features of the invention will be more readily apparent from the following detailed description and appended claims when taken in conjunction with the drawings, in which:

FIG. 1 illustrates an exemplary computer system network with which the present invention may be implemented;

FIG. 2 is a deployment diagram showing components of a system in accordance with one embodiment of the present invention;

FIG. 3 is an illustration of the Study Chooser dialog used to select an Oracle Clinical definition, in accordance with one embodiment of the present invention;

FIG. 4 is an illustration of a Study Definition Panel used to compare an Oracle Clinical definition to a macro study definition in accordance with one embodiment of the present invention;

FIG. 5 is an illustration of a configuration tab panel used to edit the electronic appearance of a macro study definition electronic case report form;

FIG. 6 illustrates processing steps in accordance with one embodiment of the present invention;

FIGS. 7A, 7B, and 7C respectively illustrate exemplary OcCpEvent, OcDci, and OcDciMod segments of a conversion map in accordance with one embodiment of the present invention;

FIGS. 8A, 8B, and 8C respectively illustrate exemplary OcQuestion, TmDerivedItem, and OcSite segments of a conversion map in accordance with one embodiment of the present invention;

FIGS. 9A, 9B, and 9C respectively illustrate exemplary OcInvestigator, OcPatient, and OcKey segments of a conversion map in accordance with one embodiment of the present invention;

FIG. 10 illustrates an exemplary SpecialValues segment of a conversion map in accordance with one embodiment of the present invention; and

FIG. 11 illustrates processing steps in accordance with one embodiment of the present invention.

Like reference numerals refer to corresponding parts throughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an apparatus and method for integrating front-end data collection systems with back-end CDMS such as Oracle Clinical. The present invention orchestrates bidirectional conversion and transportation of data, metadata, and process data between front-end data collection systems and back-end clinical data management systems. The present invention is capable of operating continuously at a plurality of back-end data warehousing sites. A number of aspects of the instant invention are accessible via open application program interfaces ("API"). In addition, the present invention provides an API that acts as a client to front-end data collection systems as well as an additional API that acts as a client to the back-end CDMS.

In one embodiment, the present invention provides an interface between a front-end data collection system having Remote Data Entry capabilities, such as MACRO from InferMed, Ltd., London UK, with a legacy back-end CDMS, such as Oracle Clinical (O/C), Oracle Inc., Redwood Shores, Calif. MACRO and Oracle Clinical were developed independently and have no common standards for data or metadata representation. Thus, one embodiment of the present invention provides an automated interface between these two products. The inventive apparatus and method interprets O/C study definitions and converts them to macro study definitions. The converted macro definitions are then loaded into MACRO. The macro definitions serve as a basis for collecting clinical data using MACRO. As study data is collected using MACRO, the instant invention translates the macro study data into a data format that can be read by O/C and loads the formatted data, on an incremental basis, into a designated O/C server. Thus, the present invention provides two important use case scenarios, (i) mapping a back-end clinical definition to a front-end study definition, and, (ii) retrieving and translating clinical data from a Remote Data Entry program, such as MACRO, and populating a back-end CDMS with the retrieved clinical data.

Overview of System Components Used in the Present Invention

The present invention provides a set of component software modules and databases that are linked together by an intranet, internet, or other wired or wireless communications systems, referred to herein as a transmission channel. A significant advantage of the present invention is that the component software modules can be configured to function when the individual component software modules are separated by large geographical distances. Another advantage of the present invention is that the system can be scaled to handle a wide range of work loads. FIG. 1 shows an exemplary system, such as system 1300, for converting a back-end clinical definition 8 to a front-end study definition 70 using the methods of the present invention. In one embodiment, back-end clinical definition 8 is an Oracle Clinical definition and front-end study definition 70 is a macro study definition. System 1300 preferably includes the hardware and software components illustrated in FIG. 1, including a back-end computer 140 that hosts a back-end O/C database 10, a server 150 that hosts a server process module 38, one or more front-end sites 104, each having a Remote Data Entry (RDE) product 68, a transmission channel 98, and clients 180 that host a console module 44 and/or a mapper client module 6.

In an overview to FIG. 1, a back-end clinical definition 8 in O/C database 10 is selected by mapper client module 6. The selected back-end clinical definition 8 is then converted to a front-end study definition 70 by mapper server module 30. The data format of back-end clinical definition 8 is quite different from that of front-end study definition 70. In fact, many of the attributes and metatables found in back-end clinical definitions 8 simply are not used in front-end study definition 70. These unused metatables and attributes are usually stored in a conversion map 32 that is created by mapper server module 30 during conversion of back-end clinical definition 8 to front-end study definition 70. Furthermore, the conversion map 32 stores the one to one correspondence between questions and events in the back-end clinical definition 8 and the front-end study definition 70. Once converted, a front-end study definition 70 is distributed to front-end sites 104. After clinical data are received by front-end sites 104, server process module 38 queries each macro database 72 for clinical data and adds the clinical data to conversion map 32. After each front-end site 104 is queried, data in conversion map 32 is used to construct a novel back-end data packet that may be read by O/C database 10.

Now that a broad overview of FIG. 1 has been given, attention now turns to front-end site 104 in FIG. 1. In fact, in a typical implementation of system 1300, there exists any number of front-end sites 104 spread out over large geographical distances. For example, each front-end site 104 may be located at a remote clinical site. In a preferred embodiment, each front-end site 104 includes:

a central processing unit 62;

a main non-volatile storage unit 61, preferably a hard disk drive, for storing software and data;

a network connection 60 for connecting front-end site 104 to transmission channel 98, which may be any wired or wireless transmission channel;

a system memory 66, preferably RAM, for storing system control programs, data, and application programs, including programs and data loaded from non-volatile storage unit 61;

a user interface 64, including one or more input devices; and

an internal bus 67, for interconnecting the aforementioned elements to the system.

Operation of each front-end site 104 is controlled by means of an operating system or a round-robin scheme in accordance with methods well known in the art. In a typical implementation, system memory includes the means for controlling front-end site 104 as well as a number of software modules and data structures used in the instant invention. These software modules and data structures include RDE product 68, one or more front-end study definitions 70, and macro database 72. Typically, a portion of one or more of these modules is stored on non-volatile storage unit 61. The function and purpose of each of these software modules will now be described.

RDE product 68. In one embodiment of the present invention, RDE product 68 is version 2.0.42 of a set of applications and utilities provided by InferMed Ltd., London, England. RDE product 68 is used to display a set of forms to a data entrant. The forms are highly specialized and present questions to the data entrant in a highly regularized manner. For example, each question present in a form may be restricted to a range of values. In addition, the RDE product 68 includes extensive scheduling information for each form presented. For example, in a multi-week trial, a form for each patient registered in the trial may be presented to the data entrant on a weekly basis in accordance with a schedule maintained by RDE product 68.

Front-end study definition 70. Each front-end study definition 70 defines the data format needed to facilitate Remote Data Entry at a particular trial site and study. An advantage of the present invention is that each front-end study definition 70 is electronically generated based on a corresponding back-end clinical definition 8 (FIG. 1). In one embodiment of the present invention, front-end study definition 70 is a macro study definition that includes the metatables described in Table 2. 

                                   TABLE 2
           Description of selected metatables in one embodiment of
                        front-end study definition 70
    Metatable Name             Metatable Function
    ClinicalTrial              The name or identifler for a particular clinical
     trial
                               that is being conducted using system 1300.
    StudyDefinition            Header information that describes basic
     properties
                               of the ClinicalTrial, such as the number of
     patients
                               to be enrolled in the study.
    TrialStatusHistory         The number of patients that have been recruited
     so
                               far.
    ReasonForChange            Tracks the reasons why any answers to questions
                               were subsequently changed by the data entrant,
     so
                               that the integrity of the clinical trial is
     maintained.
    ValueData                  Allowed answers to a DataItem.
    DataItem                   Clinical question and clinical question
     attributes,
                               such as whether alphanumeric response is
     allowed.
    DataItem validation        Range of values allowed in response to a
     DataItem.
    CaseReportFormPage         Size of form (page size), description of form,
                               including possible logo.
    CaseReportFormElement      Describes the location of an element, such as a
                               DataItem on the CaseReportFormPage
    StudyVisit                 Name of a clinical visit and the date
    StudyVisitCaseReportFormPage A link to a page in as StudyVisit
    TrialPhase                 ClinicalTrial phase


More details on these macro metatables can be found in the technical documentation for MACRO v.2.0.40, Infermed Ltd., London, England. Furthermore, a description of how the metatables listed in Table 2 are generated based on a corresponding back-end clinical definition 8 will be disclosed under "Use Case 1" below.

Macro database 72. In one embodiment of the present invention, macro database 72 is an installation of the Oracle 8i database, Redwood Shores, Calif. Macro database 72 stores clinical data in accordance with a front-end study definition 70.

Turning attention to back-end computer 140 in FIG. 1, computer 140 preferably includes:

a central processing unit 18;

a main non-volatile storage unit 19, preferably a hard disk drive, for storing software and data;

a network connection 20 for connecting back-end computer 140 to transmission channel 98;

a system memory 4, preferably RAM, for storing system control programs, data, and application programs, including programs and data loaded from non-volatile storage unit 19;

a user interface 16, including one or more input devices; and

an internal bus 5, for interconnecting the aforementioned elements to the system.

Operation of back-end computer 140 is controlled by means of an operating system or a round-robin scheme in accordance with methods well known in the art. In a typical implementation, system memory includes the means for controlling back-end computer 140 as well as a number of software modules, data files and databases used in the instant invention. Typically, portions of these software modules, data files and/or databases are stored in non-volatile storage unit 19. These software modules, data files, and/or databases include an O/C database 10 and, optionally, one or more external files 9. O/C database 10 supports an O/C clinical module 12 and an O/C data capture API 14. O/C database 10 stores O/C identifiers 3 and one or more back-end clinical definitions 8. The function and purpose of each of these software modules, data files and/or databases will now be described.

O/C database 10. An O/C database 10 is a database management system for storing and retrieving clinical data. A database management system is a software program that typically operates on a database server or mainframe system to manage data, accept queries from users about the data, and respond to those queries. A typical database management system is capable of: (i) providing a way to structure data as records, tables, or objects, (ii) accepting data input from operators and storing that data for later retrieval, (iii) providing a query language for searching, sorting, reporting, and other decision support activities that help users correlate and make sense of the collected data, (iv) providing multi-user access to the data, along with security features that prevent some users from viewing and/or changing certain types of information, (v) providing data integrity features that prevent more than one user from accessing and changing the same information simultaneously, and (vi) providing a data dictionary that describes the structure of the database, related files, and record information.

Most database management systems, such as that hosted by back-end computer 140, are client/server based and operate over networks. In the embodiment of FIG. 1, the server is the back-end computer 140, whereas the clients include front-end sites 104, clients 180 or other undisclosed clients within system 1300. Database management systems include an engine that runs on a powerful back-end computer 140 with a high-performance channel to the large data store. The back-end computer accepts requests from clients, such as client 180, that may require sorting and extracting data. Once back-end computer has processed the request, it returns the information to the client. The common language for accessing most database systems is SQL (Structured Query Language). In a preferred embodiment, back-end computer uses an Oracle database management system that operates responsive to SQL queries.

Although within the scope of the preferred embodiments, flat-file database systems are not recommended for use in system 1300. Flat-file databases are generally applicable to simple data systems, since all the information can be stored in one file. Flat-file databases are generally inadequate for complex database applications such as that of system 1300. Rather, relational database systems and/or object-oriented database systems are more appropriate for the clinical data processed by system 1300. A relational database management system, in accordance with the preferred embodiments, is a system that stores clinical data in multiple tables or metatables. The tables can be related and combined in a number of ways to correlate and view the data. A typical database for clinical data might contain hundreds of tables that can potentially produce thousands of relationships. A common element, such as a patient ID or clinical trial ID may link information across the tables.

Object-oriented databases, which are also within the scope of the preferred embodiments for O/C database 10, generally include the capabilities of relational databases but are capable of storing many different data types including images, audio, and video. Additionally, object oriented databases are adapted to store methods, which include properties and procedures that are associated with objects directly in the database. A variety of references are publicly available for further information on implementing relational and/or object oriented databases for enabling the implementation of the systems and methods disclosed herein; see, for example, Cassidy, High Performance Oracle8 SQL Programming and Tuning, Coriolis Group (March 1998), and Loney and Koch, Oracle 8: The Complete Reference, (Oracle Series), Oracle Press (September 1997), the contents of which are hereby incorporated by reference into the present disclosure.

O/C clinical module 12. In one aspect of the present invention, O/C clinical module 12 is a product of Oracle Corporation, Redwood Shores, Calif. For example, in one embodiment, O/C clinical module 12 is version 3.1.1.1 of Oracle Clinical in conjunction with Oracle database version 7.3.2. In this embodiment, the Oracle database version 7.3.2 seat is the O/C database 10. In another embodiment of the present invention, O/C clinical module 12 is Oracle Clinical v4i. O/C clinical module 12 is used to store back-end clinical definitions 8 within O/C database 10.

O/C data capture API 14. O/C data capture API 14 is an application programming interface ("API"). In one embodiment of the present invention, O/C data capture API 14 is Oracle Clinical Data Capture provided by Oracle Clinical for uploading back-end data packets from clinical field offices.

O/C identifiers 3. O/C identifiers 3 describe the corresponding O/C site, O/C investigator and O/C patient code for a particular back-end clinical definition 8.

Back-end clinical definition 8. As illustrated in FIG. 1, system 1300 includes a number of back-end clinical definitions 8 such as Oracle Clinical definitions. Back-end clinical definitions 8 in system 1300 are stored in a database such as O/C database 10. In FIG. 1, there is a set of N back-end clinical definitions 8 stored in O/C database 10.

In one embodiment of the present invention, back-end clinical definition 8 is an Oracle Clinical definition include the metatables described in Table 3. 

                                   TABLE 3
           Description of selected metatables in one embodiment of
                        back-end clinical definition 8
    Metatable Name                     Metatable Function
    CLNICAL_PLANNED_EVENT              Name or serial number for a clinical
     event
    CLINICAL_STUDY                     Short description of a clinical event,
                                       including the number of patients
     expected
                                       and the number of patients enrolled
    DATA_COLLECTION_INSTRUMENT         A series of data entry questions used in
     the
    (DCI)                              clinical event. The DCI includes
     clinical
                                       questions and clinical question
     attributes.
    DCI_BOOK                           A series of question classifications
     (sets of
                                       DCIs) that are presented to the data
     entrant
                                       for a given patient over the course of a
                                       clinical trial.
    DCI_BOOK_PAGE                      One page in DCI_BOOK. The page may
                                       include one or more DCIs.
    DCI_INSTRUMENT_MODULE              Reference to a DCI_BOOK_PAGE in the
                                       DCI_BOOK
    DATA_COLLECTION_MODULE             A group of DCIs
    (DCM)
    DCM_LAYOUT_ABS_PAGE                The layout of a 80 .times. 40 legacy
     display
                                       used by O/C data collection API 14 to
                                       display DCIs and DCMs.
    DCM_LAYOUT_GRAPHIC                 A graphic displayed on the
                                       DCM_LAYOUT_ABS_PAGE
    DCM_LAYOUT_PAGE                    A link between a DCM and a page in a
                                       DCI_BOOK.
    DCM_LAYOUT_TEXT                    A caption to a question. For example
                                       "Gender?"
    DCM_QUES_REPEAT_DEFAULT            The default number of times the group of
                                       DCIs in the DCM will be presented to the
                                       data entrant.
    DCM_QUESTION                       Screen attributes of a DCI.
    DCM_QUESTION_GROUP                 The Attributes of a DCM question group
    DCM_SCHEDULE                       When a DCM will be presented to the data
                                       entrant for a given patient.
    DISCRETE_VALUE                     Allowed response to a DCI.
    DISCRETE_VALUE_GROUP               Allowed response to a DCI.


More details on the structure of the aforementioned metatables are found in the O/C v.3.1.1.1 stable-views documentation, Oracle Corporation, Redwood Shores, Calif.

External files 9. Back-end clinical definitions 8 may be exported from the O/C database 10 and stored as external files 9. An external file 9 contains the complete description of the data structure in an internal back-end clinical definition 8. One difference between an external file 9 and a back-end clinical definition 8 is that the back-end clinical definition 8 is stored as a collection of metatables within O/C database 10 whereas the corresponding file 9 contains a complete, metatable independent, description of the clinical study. It will be appreciated that the present invention imposes no requirements on the location of external files 9 within system 1300 provided that they are at a location that is addressable by system 1300.

Turning attention to computer 150 in FIG. 1, computer 150 preferably includes:

a central processing unit 24;

a main non-volatile storage unit 23, preferably a hard disk drive, for storing software and data;

a network connection 22 for connecting computer 150 to transmission channel 98;

a system memory 28, preferably high speed random-access memory (RAM), for storing system control programs, data, and application programs, including programs and data loaded from non-volatile storage unit 23;

a user interface 26, including one or more input devices; and

an internal bus 29, for interconnecting the aforementioned elements to the system.

Operation of computer 150 is controlled by means of an operating system or a round-robin scheme in accordance with methods well known in the art. In a typical implementation, system memory includes the means for controlling computer 150 as well as a number of software and data modules used in the instant invention. These software and data modules include mapper server module 30, daemon module 36, registration module 37, server process module 38, configuration file 40, data exchange module 42, database module 48, persistent state record 110, status account book 114, one or more time stamps 76, audit trail 112, and conversion maps 32. Typically, a portion of one or more of these software and/or data modules is stored on non-volatile storage until 19. The function and purpose of each of these software and data modules will now be described.

Mapper server module 30. Mapper server module 30 converts a back-end clinical definition 8 or external file 9 into an equivalent front-end study definition 70. It also generates a translation key so that server process module 38 and data exchange module 42 can later translate data collected by RDE product 68 into a data format that is compatible with a back-end clinical definition 8. The translation key is referred to as a conversion map 32.

In one aspect of the present invention, mapper server module 30 provides a user session for each mapper client module 6 when a new connection is established. The user session maintains information while a mapper client module 6 is connected to the mapper server module. Each session is unique to a mapper client module 6. In some embodiments, mapper server module 30 allows only one connection at a time. The user session is created when a mapper client module 6 first calls the startSession( ) method. The user session is deleted when the mapper client module 6 calls the stopSession( ) method. The user session expires if it is idle for more than 30 minutes.

The user session is identified by a user name and a session token that is generated by the client 180 and sent to the computer 150 that hosts mapper server module 30. In an exemplary embodiment, the session token is a unique string generated by the Secure Hash Algorithm (SHA-1) and each method call from a mapper client module 6 contains a session token. The mapper server module 30 validates the session token and the session expiration time for each method call.

In one embodiment of the present invention, an exception is thrown when the session token is not recognized or the user session has expired. For each method call, the user session is retrieved based on the session token. A subset of properties for the study definition exists within the user session. Under such a situation, when back-end clinical definition 8 is changed, this subset of properties is replaced.

In another aspect of the invention, mapper server module 30 provides an IMap Interface. Exemplary mapper server modules 30 support mapper client modules 6 as defined by the IMap public interface shared by the two components. The methods of the IMap interface are itemized and described in Table 4 below. 

                             TABLE 4
            Public API Provided by the IMap Interface
    Name                   Description
    AddConfigurationValue  Mapper client module 6 uses this method
                           to send a new property value to Mapper
                           server module 30 for inclusion in a
                           map.properties object.
    deleteConfigurationValue Mapper client module 6 uses this method to
                           notify mapper server module 30 of a
                           property value to be deleted from the
                           map.properties object.
    DoLoadStudy            Provides instructions to a load back-end
                           clinical definition 8 for a selected study from
                           O/C database 10. The study is loaded into a
                           temporary location.
    DoSelectStudy          Causes the study definition loaded by the
                           doLoadStudy( ) method to be made.
    EditConfigurationValue Provides notification that a property value
                           is to be changed in the map.properties object.
                           The new property value is supplied.
    FindElement            Asks mapper server module 30 to find where
                           a study definition question on one server
                           is located in the study definition on
                           another server.
    generateTMStudyDefinition Mapper client module 6 sends this request to
                           mapper server module 30 in order to instruct
                           mapper server module to create (or update) a
                           front-end study definition 70 and conversion
                           map 32 based on the currently loaded
                           back-end clinical definition 8.
    Getchildren            Requests mapper server module 30 to
                           provide a set of child nodes used for
                           display in a hierarchical tree. The parent
                           node is provided.
    GetCRFElements         Requests the set of electronic case report
                           form elements that comprise a specific
                           electronic case report form page. The
                           elements are used to display a case report
    form page to the user.
    GetOCQuestion          Requests the attributes that describe a
                           question in a back-end clinical definition 8.
    GetRootNode            Requests the root node for a specific tree
                           display. A keyword is provided for the
                           requested tree.
    GetServerNameList      Returns a set of names of back-end
                           computers 140 within system 1300.
    GetStudyDescription    Requests a description of a back-end clinical
                           definition 8. Mapper server module 30 sends
                           mapper client module 6 the name of the
                           study on the currently connected back-
                           end computer 140. Mapper server module
                           30 returns a text string.
    getStudyNameList       Upon receiving this request from mapper
                           client module 6, mapper server module 30
                           returns the names of the clinical studies
                           that are present on the currently-connected
                           back-end computer 140.
    queryTMStudyStatus     Upon receiving this request, mapper server
                           module 30 determines whether a front-end
                           study definition 70 and corresponding
                           conversion map 32 should be created or
                           updated. Mapper client module 6 is
                           sent a response that is displayed to the user.
    readOCMetaFile         Upon execution of this command, mapper
                           server module 30 creates an OCMetaPacket
                           by opening a local file and converting it to
                           an OCMetaPacket.
                           Mapper server module 30 loads the
                           OCMetaPacket and sets it to be the currently
                           selected back-end clinical definition 8.
    SaveStudyDefinition    Updates macro server module 30 with the
                           currently generated front-end study definition
                           70, and updates computer 150 with the
                           currently generated conversion map 32.
    StartSession           Called by a mapper client module 6 to create
                           a new user session.
    StopSession            Called by a mapper client module 6 to stop
                           and discard the current user session.
    WriteOCMetaFile        Requests currently selected back-end clinical
                           definition 8 back to mapper client module 6
                           as an OCMetaPacket. Mapper client module
                           6 or data exchange module 42 converts the
                           OCMetaPacket to a file for local storage.


Daemon module 36. Daemon module 36 acts as the activation mechanism for server process module 38, Mapper server 30, and data exchange module 42. When an instance of the invention is started, daemon module 36 starts and automatically launches server process module 38. Daemon module 36 waits for requests to start additional server processes and to restart server process module 38 when it is stopped. In one embodiment, daemon module 36 requires little intervention and as such does not have a user interface. However, in another embodiment, it does act as the system console for all output messages and as such is typically available for monitoring when necessary.

Registration module 37. Within registration module 37, entries for different back-end computers 140 in system 1300 are placed when the servers are ready to be used. Queries to use different servers are sent to registration module 37, and the registration module replies with a reference to the requested module. If a module 38, 30 or 42 is not available when it is requested, daemon module 36 is contacted, and the corresponding server is started.

Server process module 38. Server process module 38 works in conjunction with data exchange module 42 to collect clinical data from each front-end site 104 and, using the appropriate conversion map 32, to translate the data into a back-end data packet that can be read by O/C database 10. In some embodiments of the present invention, server process module 38 includes a scheduling functionality. This scheduling functionality is used to time the frequency in which front-end sites 104 are polled for new clinical data.

Server process module 38 also interacts with database module 48 to keep a persistent record of its state. This record is stored as persistent state record 110 in database module 48. Persistent state record 110 includes the state of external system connections (to 140 and 104), the state of current data load progress, as well as statistical information about load events.

Server process module 38 also stores an audit trail of events 112 in database module 48. Audit trail 112 is categorized into either "Activity" or "Error" event types. In a preferred embodiment, these events are stored historically and are accessed via queries using languages such as structured query language (SQL).

Server process module 38 works in conjunction with other files and software modules, including configuration file 40, data exchange module 42 and console module 44.

Configurationfile 40. Configuration file 40 contains installation-specific settings, including selections of the appropriate O/C database 10 and macro database 72 instances to bridge as well as a list of clinical trials to watch. For each clinical trial watch specified by server process module 38, a special designation is made as to whether the trial is in "test mode." When a trial is in "test mode," data is loaded into O/C clinical module 12 test tables rather than O/C clinical module 12 production tables.

Data exchange module 42. This module provides an interface to front-end sites 104. This module allows a front-end study definition 70 to be loaded into a RDE product 68. This module works in conjunction with server process module 38 to extract new patient data out of front-end sites 104 so that it can be loaded into O/C database 10. In one embodiment, data exchange module 42 works in conjunction with server process module 38 to receive clinical data from a front-end site 104 and translate the data into a form that is compatible with O/C clinical module 12. This process is described with more detail below in the section entitled "Use case 2."

Console module 44. Console module 44 provides a view of server process module 38 through which a system administrator can monitor activity and execute system commands. In some embodiments of the present invention, console module 44 provides the following display panels: (i) a system status panel, (ii) a system message panel, (iii) an inspect system events panel, (iv) an inspect study status panel, (v) an inspect/change properties panel, and (vi) a tools menu.

(i) System status panel. The system status panel provides both graphic- and text-based summaries of O/C clinical module 12, RDE product 68, and server process module 38. For each software module monitored, pertinent information is provided. If the status of any of the monitored software modules changes, the system status panel is updated.

(ii) System message panel. The system messages panel provides a view of the system status that is more detailed than the view disclosed by the system status panel. In addition, text-based output from server process module 38 is displayed by the system message panel.

(iii) Inspect system events panel. The inspect system events panel provides a graph and a table that disclose a picture of server process module 38 activity. The graph shows the activity from the most recent 10 processing cycles. The graph is intended to provide a quick summary of current activity. Typically, the graph will show how many studies, sites, and patients are processed by server process module 38. The x-axis shows the process ID. The y-axis shows the count of how many of each type were processed. The table provides a view of the most recent actions and events that have occurred. Each row of the table displays the time, the process ID, the event code and the event description. Double-clicking on a table row provides a complete view of the event record.

(iv) Inspect study status panel. The inspect study status panel provides a view of data so that the system administrator is able to determine how many patients have been processed for a given front-end site 104. After selection of a clinical study associated with a front-end study definition 70 as well as a front-end site 104, the set of patients for that front-end site 104 is displayed. The list of patients confirms the enrollment for a front-end site 104. The list of patients also displays the corresponding patient numbers in the O/C database 10 and macro database 72. This allows the system administrator to compare the same patient on the two systems to verify that all information has been transferred correctly.

(v) Inspect/change properties panel. The inspect/change properties panel provides the system administrator with the ability to inspect and change the properties used by server process module 38. In some embodiments of the present invention, access privileges are enforced for this panel. That is, a user must have write access privileges in order to make any changes to the inspect/change properties panel.

(vi) Tools menu. The tools menu is used to send commands to server process module 38. These are high level commands such as Start/Stop/Enable/Disable. Each command is described in Table 5. In some embodiments of the present invention, only users who have write access are able to use the tools menu. Users with read access are not provided with the tools menu and cannot use it. 

                             TABLE 5
           Summary of the console module 44 tools menu
    Show                          Contains commands to show
    sub-menu                      status information
                  Show Version    Shows server process module 38
                                  version information.
                  Show            Shows server process module 38
                  Configuration   configuration settings.
                  Show Timer      Shows length of various timing
                                  cycles used by server process
                                  module 38.
                  Show Status     Shows status of studies and sites
                  Account         being processed by each instance of
                                  server process module 38.
                  Show Uptime     Shows elapsed time since computer
                                  150 was started.
    Front-end study
    definition                    Contains commands to change
    70 sub-                       front-end study definition 70
    menu                          processing.
                  Enable Study    Enables a study in status account
                                  book 114.
                  Disable Study   Disables a study in the status
                                  account book 114.
                  Audit Study     Compares a back-end clinical
                                  definition 8 with the front-end study
                                  definition 70 and conversion map 32
                                  to see if there are any discrepancies.
                                  The result is stored in the persistent
                                  state record (110) of database
                                  module 48.
                  Add Study       Adds a study to the status account
                                  book 114.
    Front-end
    site 104                      Contains commands that operate
    sub-menu                      on the status account book 114.
                  Enable front-end Enables a front-end site 104 for
                  site 104        processing by server process module
                                  38. The user enters both the front-
                                  end study definition 70 and the name
                                  of front-end site 104.
                  Disable front-end Disables a front-end site 104 so that
                  site 104        processing of data from the front-
                                  end site 104 no longer occurs. The
                                  user enters both the front-end study
                                  definition 70 and the name of front-
                                  end site 104.
    Restart Exec                  Directs server process module 38
                                  to restart itself. Mapper server
                                  module 30 and data exchange
                                  module 42 are also restarted.
    Reset front-end                 Operates on status account book
    sites 104                     114 to change the processing
                                  status of all studies.
    Computer 150                  Contains commands that affect
                                  computer 150 processing.
                  Update database Instructs server process module 38
                  module 48       to save the current status account
                                  information to database module 48.
                  Resume Server   Instructs server process module 38
                                  to resume processing of data, after it
                                  has been paused.
                  Pause Server    Instructs server process module 38
                                  to temporarily suspend processing of
                                  data.
                  Shutdown Exec   Instructs Server module 38 to shut
                                  down. Daemon module 36 will
                                  always restart server process module
                                  38, so this command has the same
                                  effect as a restart request.
                  Process Patient Server process module 38 is directed
                  Data            to start the next process cycle
                                  immediately.
    O/C clinical                  Contains commands for
    module 12                     connecting to O/C clinical module
                                  12.
                  Enable OC Server This command causes server process
                                  module 38 to reconnect to O/C
                                  clinical module 12 and start sending
                                  data. If problems occur back-end
                                  computer 140 is disabled.
                  Disable OC      This command disconnects the
                  Server          server hosting server process module
                                  38 from the server hosting O/C
                                  database 10.
    RDE product                   Contains commands for
    68                            connecting to front-end site 104.
                  Enable front-end Tries to reconnect to front-end site
                  site 104        104 to start querying for data. If
                                  problems occur then front-end site
                                  104 is disabled.
                  Disable front-end This command disconnects the
                  site 104        server hosting server process module
                                  38 from front-end site 104.


Database module 48. In a preferred embodiment, database module 48 is supported by an Oracle 8.x.x database server. Database module 48 provides a persistent repository for the storage of information used or generated by server process module 38. In some embodiments, database module 48 includes persistent state record 110, audit trail 112, status account book 114, and conversion maps 32.

Persistent state record 110. Persistent state record 110 includes an ACTIVITY_EVENT database table that records all of the events detected by server process module 38. Persistent state record 110 also includes an ERROR_EVENT database table that records all of the errors detected by server process module 38. Persistent state record 110 further includes STATUS_ACCOUNT and STATUS_ACCOUNT_LINE database tables that store the status of each of the studies and front-end sites 104, and the time that the last patient information was loaded. Server process module 38 uses this information when polling sites for new patient information. Database module 48 also includes a STUDY_AUDIT database table that stores the results of audits performed on studies. A study is audited whenever it is first loaded, or when a study is updated.

Status Account book 114 and time stamps 76. Status account book 114 is part of persistent state record 110 and it keeps two time stamps 76 per front-end site 104. The first time stamp 76 designates the last successfully loaded front-end clinical response data. The second time stamp designates the most recent time stamp for the front-end site 104 at which time O/C identifiers 3 were still missing for a patient. Thus, some time stamps 76 represent the time and date of the last data access from server process module 38 of computer 150. Accordingly, when server process module 38 interrogates front-end site 104 for clinical data, the time stamp 76 that corresponds to a chosen front-end study is queried. Then, all data that has been entered into the macro database 72 for the front-end study definition 70 since the time stamp 76 was last set is transferred to computer 150 for processing.

Conversion maps 32. Each conversion map 32 contains the listings of visits, forms, questions, etc. for a front-end study definition 70 and the corresponding back-end clinical definition 8. Once data translation is started by data exchange module 42, the conversion map 32 is updated with the corresponding patient numbers used for each patient by the front-end study definition 70 and the corresponding back-end clinical definition 8.

Now reference will be made to client 180. Client 180 includes:

a central processing unit 166;

a main non-volatile storage unit 164, preferably a hard disk drive, for storing software and data;

a network connection 160 for connecting client 180 to transmission channel 98;

a system memory 170, preferably RAM, for storing system control programs, data, and application programs, including programs and data loaded from non-volatile storage unit 164;

a user interface 168, including one or more input devices; and

an internal bus 162, for interconnecting the aforementioned elements to the system.

Operation of client 180 is controlled by means of an operating system or a round-robin scheme in accordance with methods well known in the art. In a typical implementation, system memory includes the means for controlling client 180 as well as one or more software modules used in the instant invention. These software module include console module 44 and/or mapper client module 6. The function and purpose of each of these software modules will now be described.

Mapper client module 6. Mapper client software module 6 is the remote user interface to mapper server module 30. It provides a user interface for creating or updating front-end study definitions 70 and their corresponding conversion maps 32. The intended user of mapper client module 6 is an electronic case report form designer or clinical programmer, a person who is involved in the design of a new clinical trial. After a clinical trial has started, mapper client module 6 may be used to update the appropriate front-end study definition 70. Mapper client module 6 provides the following functionalities: (i) loading a back-end clinical definition 8 or external file 9, (ii) generating a front-end study definition 70 based on the back-end clinical definition or external file 9, (iii) inspecting and comparing front-end study definitions 70 to back-end clinical definitions 8, and (iv) modifying electronic properties of front-end study definitions 70. These functionalities will now be described with reference to an exemplary system that uses Oracle Clinical (O/C) as the back-end CDMS and MACRO as the front-end RDE product.

(i) Loading a back-end clinical definition 8 or external file 9. A back-end clinical definition 8 defines a clinical study as a series of metadata tables within O/C database 10. In one embodiment of the present invention, mapper client module 6 provides the ability to load a back-end clinical definition 8 from an O/C database 10 using an interface such as panel 400 of FIG. 4. By clicking on the "Read From DB" button 406 in panel 400 (FIG. 4), the user is provided with a study chooser dialog window 300 of FIG. 3. Table 6 explains the purpose of each of the user interface elements provided by study chooser dialog window 300. 

                             TABLE 6
    Description of the elements of study chooser dialog window 300
    Element         Type        Purpose
    Back-end        Drop-Down   Display and select a list of back-end
    computer 140    list        computers 140 that have back-end
    selection list              clinical definitions 8 in an O/C database
    302                         10
    Study names box List Box    Display and select a back-end clinical
    304                         definition 8 from the back-end computer
                                140 designated by back-end computer
                                140 selection list 302
    Study description Text Area   Display a description of a selected back-
    box 306                     end clinical definition 8
    Load study button Button      Retrieve the back-end clinical definition
    308                         8 from the back-end computer 140
                                designated by back-end computer 140
                                selection list 302
    Study parameters Text Area   Display the contents of the selected
    box 310                     back-end clinical definition 8
    OK button 312   Button      Select a back-end clinical definition
                                8 for further processing
    Cancel button 314 Button      Close study chooser dialog window 300
                                and discard the selected back-end
                                clinical definition 8


In Study chooser dialog window 300 (FIG. 3), the user selects a server using the "OC Servers" back-end computer 140 selection list 302. Back-end computer 140 selection list 302 may point to any computer addressable within system 1300 (FIG. 1). However, back-end clinical definitions are only found on computers that host an O/C database 10. A list of servers displayed in back-end computer 140 selection list 302 from which a back-end clinical definition 8 may be selected is provided by any one of a number of methods. For instance, each back-end computer 140 in system 1300 (FIG. 1) could be registered in a registry in memory of 28 of computer 150. Study chooser dialog window 300 would then read this registry and display it as back-end computer 140 selection list 302. Once a server has been selected, the list of back-end clinical definitions 8 available in an O/C database 10 on the selected server is displayed in study names box 304.

Rather than loading a back-end clinical definition 8 from an O/C database 10, an external file 9 may be loaded by mapper client module 6 using the "Read from File" button 404 of panel 400. An external file 9 includes a complete description of a clinical study. When the user selects "Read from File" button 404, a panel similar to that of panel 300 is displayed. Such a panel is then used to select an external file 9 within system 1300 to load.

(ii) Generate a front-end study definition 70. As described in more detail below, a front-end study definition 70, such as a macro study definition, defines a clinical study as a series of metadata tables. These metatables are optimized for Remote Data Entry. Once mapper client module 6 has loaded a back-end clinical definition 8 using panel 300 (FIG. 3) or an external file 9 using a window similar to that of panel 300, a corresponding front-end study definition 70 is generated using the "Generate Study" button 402 of panel 400 (FIG. 4). Once button 402 is pressed, a front-end study definition 70 that matches the loaded back-end clinical definition 8 is displayed in field 440 of panel 400.

In one embodiment of the present invention, when a user uses "Generate Study" button 402 to request that a front-end study definition 70 be generated, the current state of system 1300 is analyzed and the user is notified of the results. In particular, if the front-end study definition 70 or the corresponding conversion map 32 is not present in system 1300, the user is prompted to approve the creation of a new front-end study definition 70 and corresponding conversion map 32. If both a front-end study definition 70 and a conversion map 32 that correspond to the selected back-end clinical definition 8 are present in system 1300 and patient data has not been entered, then the user is prompted to approve the update of the existing front-end study definition 70 and the corresponding conversion map 32. If both the front-end study definition 70 and the corresponding conversion map 32 are present and patient data has been entered, then the user is notified that the current front-end study definition 70 and the conversion map 32 cannot be changed. The user is notified when mapper client module 6 has finished generating front-end study definition 70 and a conversion map 32 that correspond to the selected back-end clinical definition 8. A dialog window displays the results of the study definition process. If any problems occurred, warning or error messages are displayed in the dialog window.

(iii) Inspect and compare study definitions. Once study definitions are loaded and generated, panel 400 (FIG. 4) provides hierarchical tree viewers for