Chapter 5. Module 5. User-defined Properties

Table of Contents

5.1. Tests & Requirements
5.2. Begin Module 5. User-defined Properties.
5.3. Defining User-defined property tags in DFsetup.
5.4. Adding Global User-defined property values.
5.5. Adding Plate, Module and Variable level User-defined property values
5.6. Exporting User-defined property tags in DFsetup.
5.7. Edit checks execution of User-defined property tags.
5.8. Creating subject data lists and exporting data views.
5.9. DFexplore Database Definition Report exporting.
5.10. End Module 5. User-defined Properties.

5.1. Tests & Requirements

  1. Defining User-defined property tags in DFsetup.

  2. Adding Global User-defined property values.

  3. Adding Plate, Module and Variable level User-defined property values

  4. Exporting User-defined property tags in DFsetup.

  5. Edit checks execution of User-defined property tags.

  6. Creating subject data lists and exporting data views.

  7. DFexplore Database Definition Report exporting.

Estimate of Time Required: 30 Minutes

5.2. Begin Module 5. User-defined Properties.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click 5. User-defined Properties followed by Begin to begin this module.

  3. This module requires user data_manager to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

5.3. Defining User-defined property tags in DFsetup.

  1. Start DFsetup, login as data_manager and choose 254 Acceptance Test Study as described in Section 1.8, “How to start DFsetup.

  2. Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

  3. Select Study > User-defined Property Tags.

  4. Click the empty cell for DFSTUDY_ USER1 to make it the active field.

  5. Beginning with DFSTUDY_ USER1 column. Enter the User-defined property tags for DFSTUDY_ property tags as follows:

    • USER1 = TITLE

    • USER2 = SPONSOR

    • USER3 = PLANSUBJECTS

    • USER4 = TRIALPHASE

    • USER5 = TRIALTYPE

    • USER6 = LENGTH

    • USER7 = REGID

  6. Click DFPLATE_ USER1, column. Enter the User-defined property tags for DFPLATE_ property tags as follows:

    • USER1 = V1

    • USER2 = V2

  7. Click DFMODULE_ USER1 column. Enter the User-defined property tags for DFMODULE_ property tags as follows:

    • USER1 = XXTEST

    • USER2 = XXTERM

    • USER3 = XXTRT

    • USER4 = XXCAT

    • USER5 = XXSCAT

    • USER6 = XXFAST

  8. Click DFVAR_ USER1 column. Enter the User-defined property tags for DFVAR_ property tags as follows:

    • USER1 = EC_PLT_ENTER

    • USER2 = EC_FLD_ENTER

    • USER3 = EC_PLT_EXIT

    • USER4 = EC_FLD_EXIT

  9. Click OK to apply the newly defined properties.

5.4. Adding Global User-defined property values.

  1. Select Study > Global Settings. Click User-defined tab.

  2. In the User-defined tab set the following:

    • TITLE = DFdiscover 2020 Acceptance Test Study

    • SPONSOR = Pharma 123 Inc.

    • PLANSUBJECTS = 100

    • TRIALPHASE = PHASE III TRIAL

    • TRIALTYPE = TREATMENT

    • LENGTH = 4 MONTHS

    • REGID = NCT00000001

    Click OK to save and dismiss the dialog.

5.5. Adding Plate, Module and Variable level User-defined property values

  1. Click 1 - Blood Pressure Screening Visits to make it the active page. Within the Plate Properties window click User-defined tab.

  2. Enter the Property Value tags as follows:

    • V1 = 1 October 2014

    • V2 = 11 November 2014 - Corrected error in Eligibility Criteria item 6.

    Click Apply.

  3. Select View > Plates.

  4. Within row 2 Patient Entry Form navigate to the V1 column. Enter 1 October 2014. In the V2 column enter 11 November 2014 - Updated randomization instructions.. Click Apply, Done.

  5. From the Plates-Modules-Fields window double-click 2 - Patient Entry Form. Click Keys [1] to make the module active.

  6. In the Module Properties window specify PTKEYS for the XXTEST Property Value. Click Apply.

  7. Double-click Randomization [1]. In the Module Properties window specify RANDCODE for the XXTEST Property Value. Click Apply.

  8. Select Medication Code # field. Click User-defined from the Field Properties window.

  9. Enter [MissingQC] Response is required. in the EC_FLD_EXIT Property Value.

  10. Click Edit checks tab within the Field Properties window.

  11. Enter MissingQC, sdv next to Field Exit, click Apply.

  12. Click Weight (lbs) field, then User-defined. Enter [WeightEquiv] Weight conversion. in the EC_FLD_EXIT Property Value. Click Apply.

  13. Select File > Save [Required].

5.6. Exporting User-defined property tags in DFsetup.

  1. Select File > Export Setup >Excel.

  2. Click Field Properties ....

  3. In the resulting dialog, click Select none.

  4. Select Name, Alias, Description, EC_PLT_ENTER, EC_FLD_ENTER, EC_PLT_EXIT and EC_FLD_EXIT. Click OK.

  5. Specify module5_setup.xlsx as the Output File name, enable (check) Open output file after export.. Click Export.

  6. In the exported Excel file open the Global Settings tab to view the newly defined Global Property tags.

  7. Click 2 - Patient Entry Form to view the newly defined Plate Property tags. Return to DFsetup.

  8. Select File > Exit to close DFsetup.

5.7. Edit checks execution of User-defined property tags.

  1. Start DFexplore, login as data_coordinator and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore. Upon logging in a dfmessage edit check dialog is displayed containing the DFsetup-Global Settings User-defined property tags defined in Section 5.3, “Defining User-defined property tags in DFsetup.”. Click OK to close the dialog.

  2. Select File > Preferences, click Background Options to expand the preferences. Click Color then OK to apply the changes.

  3. Select Select > Change Mode & Level. Set:

    • Mode = Validate

    • Save level = 3 - Level 3

    • Check (enable) Enable edit checks.

    Click OK.

  4. Double-click Site 99 - Hospital #99 > 99010 > 1 : Baseline > 2 : Form 2.

  5. Click anywhere on the page background to make the fields active. Press Tab to advance to the Medication Code # field.

  6. Press Tab to exit the field and execute the sdv edit check.

  7. Click OK to add the edit check containing the User-Defined Property Value's added in Section 5.3, “Defining User-defined property tags in DFsetup.”.

  8. Press Tab to advance through the remainder of the fields on the Patient Entry Form page. Verify that the Save information bar at the bottom of the screen indicates that the saved page will be assigned a record level of 3. Click Incomplete.

5.8. Creating subject data lists and exporting data views.

  1. Select View > List.

  2. Click 002 - Patient Entry Form.

  3. Select Select > Field Selection to show the listing of all data fields and their metadata properties defined for the plate. In the Data Fields window, click next to fields 7:SUBJID , 10:EXREFID , 12:WTKG , 13:WTLB.

    [Note]Note

    Alternatively fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

  4. In the Metadata Fields window, click next to field EC_FLD_EXIT to add the field to the Display Fields window. From the drop-down select 10:EXREFID, click and drag the field to be below the 10:EXREFID - Medication Code # field.

  5. Return to the Metadata Fields window, click next to field EC_FLD_EXIT to add the field to the Display Fields window. From the drop-down select 13:WTLB.

  6. Click Done to apply the field selection criteria and close the dialog.

  7. Select File > Export Data to save the data to a local file. In the dialog, set:

    • Format = Excel

    • Check (enable) Include header as the first record in output file.

  8. Click ... next to Output File. Choose a directory in the file selection dialog, enter module5_data.xlsx as the filename, and click Save. Click Save to create/write the file and close the dialog.

5.9. DFexplore Database Definition Report exporting.

  1. Select View > Reports.

  2. Double-click DFdiscover Reports > Study Setup > Database Definition.

  3. Click Run.

  4. Select File > Save Output as > Excel.

  5. Click ... next to Output File. Choose a directory in the file selection dialog, enter module5_definitions.xlsx as the filename and click Save. Check (enable) Open output file after export and click Save.

5.10. End Module 5. User-defined Properties.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click End to confirm successful completion of Module 5. User-defined Properties.