Chapter 19. Module 19. DFengage ePRO Data Entry
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Chapter 19. Module 19. DFengage ePRO Data Entry

Table of Contents

19.1. Introduction
19.2. Tests & Requirements
19.3. Begin Module 19. DFengage ePRO Data Entry.
19.4. Create DFengage users role in DFadmin
19.5. Add bulk DFengage users accounts to DFadmin
19.6. Installation and initial DFengage login.
19.7. Complete a task in online mode.
19.8. Complete a task in offline mode.
19.9. Sync data collected offline to your DFdiscover server.
19.10. Confirm data sent to the server using DFexplore.
19.11. End Module 19. DFengage ePRO Data Entry.

19.1. Introduction

[Warning]Warning

Optional Module.  The DFengage ePRO Data Entry module requires the DFWS feature (web services API). If your DFdiscover server is not licensed for this feature, do not complete this module.

DFengage is compatible with the following mobile device operating systems:

  • iOS®

  • Android

19.2. Tests & Requirements

  1. Create DFengage users role in DFadmin

  2. Add bulk DFengage users accounts to DFadmin

  3. Installation and initial DFengage login.

  4. Complete a task in online mode.

  5. Complete a task in offline mode.

  6. Sync data collected offline to your DFdiscover server.

  7. Confirm data sent to the server using DFexplore.

Estimate of Time Required: 15 Minutes

19.3. Begin Module 19. DFengage ePRO Data Entry.

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

  2. Click 19. DFengage ePRO Data Entry followed by Begin to begin this module.

19.4. Create DFengage users role in DFadmin

  1. Start DFadmin. Login to your DFdiscover Server as datafax.

  2. Specify a Username and datafax, and the assigned user password in the Password field. Click Login. to complete login and continue.

  3. Create a role for DFengage users. Begin this task by clicking the Roles tab.

  4. Within the list of studies, locate and choose the entry for 254 Acceptance Test Study. Click New to add a new user role. In the dialog, enter the role name ePROData.

  5. Click Create to create the new role ePROData.

  6. Define Tools & Reports permissions for the ePROData role. Highlight ePROData in the Roles list to make it the active role. Enter ePROData user permissions in the Description field.

  7. Click Tools & Reports tab below the Description field. Set each of the following:

    In the DFexplore & API Clients panel,

    • Check (Enable) Data within DFexplore Views

    • Check (Enable) DFengage within API Clients

    In the Server & DFsetup panel,

    • Check (Enable) View within Setup

  8. Click Permissions tab.

  9. Set plates 31-33 data permissions as follows:

    • Visits = 301-303

    • Plates = 31-33

    • Levels = ALL

    • Modify = 1-5

    • Write Levels = 1

    • Data = Check (enable) CM (Create, Modify)

    • Reasons = Check (enable) M (Modify)

  10. Set plate 30 data permissions as follows:

    • Visits = 300

    • Plates = 30

    • Levels = ALL

    • Modify = 1

    • Write Levels = 1

  11. Select File > Save or click Save to save settings for role ePROData.

19.5. Add bulk DFengage users accounts to DFadmin

  1. Still as datafax and with the DFadmin application open, click Users tab to open the user definition window.

  2. Click Add Bulk Users.

  3. In the resulting Add Bulk Users dialog, set:

    • Study = Select 254 Acceptance Test Study

    • Role = Select ePROData

    • Username Prefix = atk_

    • Subjects Range = 99001-99015

    • Check (enable) Preview usernames

    • Set an Initial Password by entering a passowrd of your choice.

    • Click Add 15 user accounts, in the resulting confirmation dialog click Yes to add the defined user accounts.

    Click Close.

    [Note]Note

    Remember the password assigned in this step as it is needed in future tests.

  4. Choose the atk_99015 entry from the list of users. Click Permissions tab to confirm the assigned permissions.

  5. Click Permissions tab. Set:

    • Study = Select 254 Acceptance Test Study

    • Sites = 99

    • Subjects = 99015

    • Role Name = ePROData

  6. Select File > > Save > Exit to close DFadmin.

19.6. Installation and initial DFengage login.

  1. Download and install DFengage from Google Play™ or Apple® App Store® to your mobile device or tablet.

  2. Open DFengage.

  3. In the DFengage login dialog, enter atk_99015 in the Username field and the previously assigned password in the Password field. Enter the name for DFdiscover Server that has been provided by your administrator and the DFdiscover Server API servername. Click Login to login.

  4. The change password dialog is presented. Enter a password of your choice, click Set new password.

  5. The Pincode setup dialog is presented. Enter any 4-digit numeric pincode. Click Continue.

  6. Select the default language, click Continue.

19.7. Complete a task in online mode.

  1. Click Start next to eDiary Day 1.

  2. Click Today's date, Select a date of 01 Jun 2023. Click OK, then Next.

  3. Complete the remaining eDiary Day 1 questions by entering the following and clicking Next on each screen:

    14:45:00

    • What time is it? = 2:45 PM, click OK

    • The first set of questions relate to recations at or around the site of vaccination.

      • Is there redness? = Y

      • Maximum severity of redness = Does not interfere with activity.

      • Medication taken for redness? = N

    • Check the box next to each symptom you have experienced today

      • Nausea = Checked (enabled)

      • Headache = Unchecked (disabled)

      • Fatigue = Checked (enabled)

      • Joint Aches = Unchecked (disabled)

      • Muscle Aches = Unchecked (disabled)

      • No Symptoms = Unchecked (disabled)

    • On a scale of 1 to 10, with 1 being the lease and 10 being the worst pain imaginable , how severe were your symptoms today? = 7

    • Please take your temperature using the provided thermometer. Record your temperature here (degrees F) = 98.4

    Click Finish.

  4. Close the DFengage application

19.8. Complete a task in offline mode.

  1. Switch your device to airplane mode or otherwise disconnect from the internet.

  2. Open DFengage, login with your pincode. Click Start next to eDiary Day 2 (plate 32).

  3. Click Today's date, Select a date of 02 Jun 2023. Click OK, then Next.

  4. What time is it? enter 5:30 PM, click OK, the time field shows as 17:30:00. Click Next.

  5. Confirm you have reviewed the instructions by checking (enabling) Read and Understood (Continue to next screen). Complete the remaining eDiary Day 2 questions by entering the following and clicking Next on each screen:

    • Pain = Quite a bit

    • Redness = Not at all

    • Swelling = A little bit

    • Itching = A little bit

    • Nausea/Vomiting = Not at all

    • Headache = Not at all

    • Fatigue = Very Much

    • General felling unwell = Quite a bit

    • Joint aches = Not at all

    • Muscle aches = A little bit

    • Other Symptoms? = N

    • Did you take medication for any of these symptoms? = N

  6. Click Finish to save the questionnaire.

  7. Click History, confirm eDiary Day 2 as Pending with the current date and time of completion, and eDirary day 1 is synced.

  8. Close DFengage applicaiton.

19.9. Sync data collected offline to your DFdiscover server.

  1. Switch off airplane mode on your device or otherwise re-connect to the internet.

  2. Open DFengage, login with your pin code. Go to History and confirm you are shown as online. If the eDiary Day 2 questionnaire is still shown as Pending, click Sync to send the questionnaire to the server. Once complete, confirm that eDiary Day 2 is shown as sent with the expected date and time.

  3. Close DFengage applicaiton.

19.10. Confirm data sent to the server using DFexplore.

  • Login to DFexplore, go to Data View, open subject 99015. Confirm the data entered in 19.7 and 19.8 now appear in DFexplore.

19.11. End Module 19. DFengage ePRO Data Entry.

  • Return to the DFATK application. Click End to confirm successful completion of Module 19. DFengage ePRO Data Entry.

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