Chapter 6. Module 6. Subject Alias

Table of Contents

6.1. Tests & Requirements
6.2. Begin Module 6. Subject Alias.
6.3. Importing and Modifying Subject Alias Map using DFsetup.
6.4. Creating Subjects using Subject Alias.
6.5. Subject Alias Tracking (Reports).
6.6. Exporting Subject Alias data.
6.7. End Module 6. Subject Alias.

6.1. Tests & Requirements

  1. Importing and Modifying Subject Alias Map using DFsetup.

  2. Subject Alias Tracking (Reports).

  3. Exporting Subject Alias data.

Estimate of Time Required: 20 Minutes

6.2. Begin Module 6. Subject Alias.

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

  2. Click 6. Subject Alias followed by Begin to begin this module.

  3. Click Send Subject Alias Map to email a copy of subject_alias_map.csv to data_manager. Clicking more than once will result in multiple files arriving to your email inbox.

    [Note]Note

    Save the subject_alias_map.csv file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for data_manager to receive the module specific files.

  4. 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.

6.3. Importing and Modifying Subject Alias Map using DFsetup.

  1. Start DFsetup, login as user 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 edit the Subject Alias Map.

  3. Select View > Subject Alias Map.

  4. Click Import. From the file selection dialog, locate the previously saved subject_alias_map.csv file.

  5. Select the file, click Open, then Save.

    [Note]Note

    Clicking Save triggers the initial import of the Subject Alias Map to be logged in DFsubjectaliasmap.log which leads to the output produced in Section 6.5, “Subject Alias Tracking (Reports).”.

  6. Modify the following Alias definitions:

    • 99002 from S254-09-9003 to S254-09-9002

    • 99006 from S254-09-9006-@ANK to S254-09-9006

    • 99007 from S254-09-9007-@KFC to S254-09-9007

  7. Click Save then Done to apply the modifications to the Subject Alias Map.

  8. Select File > Exit to close DFsetup.

6.4. Creating Subjects using Subject Alias.

  1. Start DFexplore , login as user data_manager and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore.

  2. Double-click Site 99 - Hospital #99 to open the list of available subjects.

  3. Select File > Preferences. Check (enable) Use subject alias. Click OK. The Subject ID list now displays the Subject Alias Mapping as defined in DFsetup.

  4. Click Site 99 - Hospital #99 > S254-09-9008 > 1: Baseline > 21: Lab Results to make it the active page.

  5. Select Subject > New Subject. Set:

    • Subject Alias = S254-09-9011

    • Confirm Alias = S254-09-9011

    Click OK.

  6. The message This subject alias does not exist is displayed. Click Cancel to dismiss the New Subject dialog.

    [Note]Note

    All Subject Alias definitions are required to be defined within DFsetup. Users are unable to add new Subject Alias definitions within DFexplore.

  7. Double-click S254-09-9012 then entry for 0 : Screening Visits to display the list of pages belonging to the visit. Page 1 : Form 1 becomes the active page. The data window redraws with the plate background and related data entry fields.

  8. Click anywhere on the plate background - this moves the mouse and keyboard focus to the data window.

  9. Beginning at the Patient Number field, press Tab to advance to the Patient Initials. Enter the initials TVM Press Tab to advance to the Age field.

  10. Beginning with the Age field set the following values:

    • Age = 44

    • Sex = Female

    • Race = African American

    • Screen 1 = 26/04/20

  11. As outstanding required data fields exist on the page it must be saved to the database with a status of Incomplete. Click Incomplete.

  12. Select View > List. Select 001 - Blood Pressure Screening Visits.

  13. Confirm an entry exists for S254-09-9012.

6.5. Subject Alias Tracking (Reports).

  1. Select View > Reports to switch to Reports View. In the reports list panel, double-click DFdiscover Reports followed by Subject Tracking. Highlight the report Subject Alias Map. Click Run.

  2. Click History of Subject Alias Report then Run.

6.6. Exporting Subject Alias data.

  1. Select View > List.

  2. Confirm that 001 - Blood Pressure Screening Visits is still the active plate.

  3. Select File > Export Data.

  4. In Export Data dialog set:

    • Format = Excel

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

    • Check (enable) Open output file after export

  5. Click Output File .... In the file selection dialog, choose a directory in which to save the Excel file. Once a directory has been chosen, append the file name module6_dataexport.xlsx to the directory name. Click Save.

  6. After saving, the file module6_dataexport.xlsx opens. The SUBJID displays the Subject Aliases.

  7. Return to DFexplore. Select View > Data.

  8. Create a task record set by selecting Select > By Data Fields. Set:

    • Mode = View

    • Plate = 21

  9. Click Done then OK.

  10. Select File > Save as PDF.

  11. In the Selection Criteria panel,

    • Select (enable) Data and images followed by current task set

    In the Save Options panel,

    • Check (enable) Data records and expand text fields for plates

    • Check (enable) Apply field color for completed plates

  12. Click Output File .... In the file selection dialog, choose a directory in which to save the PDF.

    Once a directory has been chosen, append the file name subjectalias.pdf to the directory name. Click Save.

  13. Complete the specification by clicking Save. There will be a busy pause while the PDF of completed data pages and their primary images is created.

  14. Locate and open the previously saved subjectalias.pdf file. Confirm the Patient Number fields within the PDF are identical to that shown in DFexplore Data View.

  15. Select File > Preferences. Uncheck (disable) Use subject alias. Click OK.

  16. Select File > Exit to close DFexplore.

6.7. End Module 6. Subject Alias.

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

  2. Click End to confirm successful completion of Module 6. Subject Alias.