Chapter 18. Module 18. DFcollect Mobile Data Collection
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Chapter 18. Module 18. DFcollect Mobile Data Collection

Table of Contents

18.1. Introduction
18.2. Tests & Requirements
18.3. Begin Module 18. DFcollect Mobile Data Collection.
18.4. Installation, App preferences and initial DFcollect login.
18.5. Online data record creation.
18.6. Download subject data for offline use.
18.7. Create data records in offline mode, query resolution and adding reasons for data values.
18.8. Sync data collected offline to your DFdiscover server.
18.9. Clearing DFcollect cache.
18.10. Adding, reviewing and downloading subject documents.
18.11. Confirming data sent to the server using DFexplore.
18.12. Add an Electronic Signature (eSign) to a set of completed subject records.
18.13. Verify removal and Re-applicaton of eSignatures.
18.14. Verify DFcollect saves eSignature task data to the specified level.
18.15. End Module 18. DFcollect.

18.1. Introduction

[Warning]Warning

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

DFcollect is compatible with the following mobile device operating systems:

  • iOS®

  • Android

18.2. Tests & Requirements

  1. Installation, App preferences and initial DFcollect login.

  2. Online data record creation.

  3. Download subject data for offline use.

  4. Create data records in offline mode, query resolution and adding reasons for data values.

  5. Sync data collected offline to your DFdiscover server.

  6. Clearing DFcollect cache.

  7. Adding, reviewing and downloading subject documents.

  8. Confirming data sent to the server using DFexplore.

  9. Add an Electronic Signature (eSign) to a set of completed subject records.

  10. Verify removal and Re-applicaton of eSignatures.

  11. Verify DFcollect saves eSignature task data to the specified level.

Estimate of Time Required: 35 Minutes

18.3. Begin Module 18. DFcollect Mobile Data Collection.

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

  2. Click 18. DFcollect followed by Begin to begin this module.

18.4. Installation, App preferences and initial DFcollect login.

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

  2. Open DFcollect.

  3. Click > Preferences. Set:

    System Setting

    • API Server = your API servername

    • Offline Only = Disabled (greyed out)

    Click Close to apply settings.

  4. Click > About DFcollect Confirm that the version information in the about dialog matches the installed DFcollect Version 5.8.X. Click Close to return to the DFcollect login screen.

  5. In the DFcollect login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter site_monitor in the Username field and the previously assigned password in the Password field. Click Login to login.

  6. From the list of available studies, click 254 Acceptance Test Study, if not already opened.

  7. Click 99: Hospital #99 to display a list of available subjects.

  8. Click > Study Help to view any study related help messages. Click Close to close the Study Help window.

  9. Click to open Dashboard view.

  10. Click View Outstanding Queries located under Outstanding Queries by Type to view all outstanding queries.

  11. Click Close to return to the subject listing.

  12. Click to search for a subject ID number, enter 99010. Click , subject 99010 : (Final) gains the focus.

18.5. Online data record creation.

  1. Click subject 99010 : (Final) to view the list of study visits.

  2. Click 1: Baseline > 2: Form 2. Plate Form 2 becomes the active page.

  3. Click Patient Initials. The initials automatically populate this field as a result of the edit check SetInit described in Module 8. Image Data Entry. Set:

    • Entry Date = Click , select 14/11/18.

    • Medication Code # = 2524

    • Date of Birth = Click , select 11/05/69.

    Click .

  4. Click > > 99009 : (Incomplete) > 21: 1 Month Follow-up > 5: Form 5, 1 Month.

  5. Click Patient Initials. The initials automatically populate this field as a result of the edit check SetInit described in Module 8. Image Data Entry. Set:

    • Visit Date = Click , select 14/11/18.

    Click .

  6. Click > > 99010 : (Incomplete) 51: Medication Log Page 1 > 8: Form 8, Pg 51.

  7. Enter Pred in the 2. Drug Name text field, press Tab. Upon leaving the field, an edit check is executed and DFlookup: drugs dialog appears.

  8. Enter prednisone in the Search Terms, Check Match ANY terms. Click Search to filter results.

  9. Locate the entry for prednisone in the results table. Double-click the entry to auto-populate the field. The 2. Drug Name field is auto-populated with prednisone, the field contains a Reason for Data Value and Type of Change field gains focus.

  10. Beginning with the Type of Change field complete the remaining data fields as follows:

    • Type of Change = Select New Drug

    • Date of Change = Select 22/11/18

    • Current Total Dose Per Day = 250

    Click .

18.6. Download subject data for offline use.

  1. Click > Storage & Syncing.

  2. Click to show the subject listing for 99: Hospital #99.

  3. Check (enable) subjects 99008: 0 visits, 99009: 0 visits and 99010: 0 visits.

  4. Click to download the subjects. After completion, click OK to dismiss the Download Progress: Data window. Upon successful download there is an icon showing the date and time the download was performed.

  5. Click > Logout to logout of DFcollect.

18.7. Create data records in offline mode, query resolution and adding reasons for data values.

  1. Click > Preferences > Offline Only toggle button to enable Offline Only mode (becomes green). Click Close.

  2. In the DFcollect login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter site_monitor in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Click 99: Hospital #99 > 99009 : (incomplete) > 21: 1 Month Follow-up > 5: Form 5, 1 Month. Set:

    • Blood Pressure: Reading 1: systolic = 142, diastolic = 097

    • Blood Pressure: Reading 2: systolic = 134, diastolic = 091

    • Blood Pressure: Arm = Right

    • Weight (lbs) = Click , select Missing Value from the Code drop-down list. Click Apply.

    Click . Click Cancel in the resulting Add Query dialog.

  4. Click > 21: Lab Results.

  5. Click Patient Initials. The initials automatically populate this field as a result of the edit check SetInit described in Module 8. Image Data Entry, Set:

    • Collection Date = Click , select 11-NOV-2018.

    • White Blood Cell = 07.8, check (enable) NORMAL

    • Red Blood Cell = 02.9 check (enable) NORMAL

    • Hemoglobin = 06.5, check (enable) ABNORMAL

    • Mean Cell Hemoglobin Conc = 14.1, check (enable) NORMAL

  6. Click , to the right of the Hemoglobin “ABNORMAL/NORMAL” field.

  7. Click ... next to Reason. The DFlookup: REASON dialog is displayed.

  8. Select the Result of Confirmed, this value is correct as entered., Click OK, followed by Apply then Click .

  9. Return to the subject listing for 99: Hospital #99 by clicking > .

  10. Click > Query View to view outstanding queries.

  11. Locate and select the outstanding query for subject 99009 > Pulse(beats/min) field. Click Open. The Pulse(beats/min) field gains focus.

  12. Click next to the Pulse field. In the Reason field specify Value of 95 for pulse is confirmed.. Click Apply > .

  13. Click to return to Query View. Confirm the outstanding query for 99009 > Pulse(beats/min) field is no longer present. Click Close.

  14. Click 99008 : (Final) > 1: Baseline > 2: Form 2. In the Date of First Study Follow-up field click , select 14/11/18.

  15. Click . In the Reason field specify Subject has to reschedule due to conflict.. Click Apply > .

  16. Return to the subject listing for 99: Hospital #99 by clicking > . Re-open Query View by clicking > Query View.

  17. Locate and select the outstanding query for subject 99009 > Age (years). Click Open. The Age (years) field gains focus.

  18. Correct Age (years) from 44 to 68. Click > , select Resolved from the Status drop-down list. Click Apply > Close.

  19. Click Race. Select african american, the query box changes from outstanding to resolved. Click .

  20. Click to return to Query View. Confirm the outstanding query for 99009 > Age (years) and Race fields are no longer present. Click Close.

  21. Click 99010 : (Incomplete) > 1: Baseline > 2: Form 2. Set:

    • Weight (lbs) = 267.0, click OK in the resulting dialog.

    • Height (in) = 072.8

    • Pulse = click , select Missing Value from the Code drop-down list.

    • Smoking Status = Never smoked

    • Date of First Study Follow-up = Click , select 05/12/18.

    Click .

    [Note]Note

    The Weight (kgs) and Height (cm) fields are auto-populated as a result of edit checks.

  22. Click > Logout, to logout of DFcollect.

18.8. Sync data collected offline to your DFdiscover server.

  1. Click > Preferences > Offline Only toggle button to disable the Offline Only mode (becomes greyed out). Click Close.

  2. In the DFcollect login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter site_monitor in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Upon logging into DFcollect, the icon is displayed next to 99: Hospital #99 indicating there are cached changes in DFcollect that have not been saved to the database.

  4. Click > Storage & Syncing.

  5. Click to expand list of subjects. Check (enable) subjects 99008: 2 Visits, 99009: 3 visits and 99010: 3 visits.

  6. Click to upload the previously entered subject data. When the upload is complete, click OK to dismiss the Upload Progress window. The icon shows the date and time of successful upload.

18.9. Clearing DFcollect cache.

  1. Check (enable) subjects 99008: 2 visits , 99009: 3 visits and 99010: 3 visits.

  2. Click then Apply within the Delete Records from Storage dialog. The icon showing the date and time are cleared.

18.10. Adding, reviewing and downloading subject documents.

  1. Click > 99008 : (Final) > 1: Baseline > 21: Lab Results.

  2. Click to view the attached documents.

  3. Click > Logout.

18.11. Confirming data sent to the server using DFexplore.

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

  2. Select Site 99: Hospital #99 > subject 99009 > 0: Screening Visits > 1: Form 1. Verify and review the data uploaded is correct.

    • Age (years) = 68 with a resolved corrected query.

    • Race = 2 (african american) with a resolved corrected query.

  3. Select File > Exit to close DFexplore.

18.12. Add an Electronic Signature (eSign) to a set of completed subject records.

[Note]Note

eSignatures require password permission to be set in the user role at the DFadmin level. The Password permission must be granted for the specific eSignature plate.

  1. In the DFcollect; login dialog, enter the DFdiscover Server name that has been provided by your administrator. Enter site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.

  2. As user site_invest has 2FA enabled, enter security code received by email as previously defined.

    [Note]Note

    Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for site_invest to receive 2FA codes.

  3. From the Subjects list, click Subject 99011 > 30: Study Termination > 7: Form 7.

  4. Click Patient Initials enter SIG, Set:

    • Final Visit Date = 03/06/22

    • 1. Did patient complete the entire study? = No

    • Check (enable) Why? Moved away

    • Check (enable) 2. Last does of study medication: Unknown

    Click . to save and eSign the Study Termination form.

  5. In the dfpassword confirmation dialog enter the user name site_invest and the corresponding password. Click Sign to apply the electronic signature to the current page.

  6. Examine the 3 eSignature fields at the bottom of the page.

  7. Click > Logout to exit DFcollect.

18.13. Verify removal and Re-applicaton of eSignatures.

  1. In the DFcollect login dialog, enter the DFdiscover Server name that has been provided by your administrator. Enter site_monitor in the Username field and the previously assigned password in the Password field. Click Login to login.

  2. From the Subjects list, click Subject 99011 > 30: Study Termination > 7: Form 7.

  3. Click 2. Last dose of study medication: Date field. Click to open the Add Query dialog. In the dialog, set:

    • Category = Missing

    • Enter Investigator to confirm last dose taken with subject during clinic visit. in the Note field.

    • Click Apply > Close to apply the query.

  4. Press Tab to advance to the 2. Last dose of study med: Unknown field. Un-check (disable) the checkbox. Click .

  5. Click > Logout to exit DFcollect.

  6. In the DFcollect login dialog, enter the DFdiscover Server name that has been provided by your administrator. Enter site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.

  7. Click > Task listing.

  8. Locate the eSignatures - Study Termination - eSignatures task. Click Open.

  9. From the Subjects list, select subject 99011 > 30: Study Termination > 7: Form 7. Click Open

  10. Click the 2. Last dose of study medication: Date field. Click then . Select Resolved from the Status drop-down list. Enter Confirmed date of last medication dose verbally with subject during clinic visit. in the Note field. Click Apply, Close.

  11. Enter the 2. Last dose of study medication: Date as 02/06/22. Click .

  12. In the dfpassword confirmation dialog enter the user name site_invest and the corresponding password used for login in Section 13.6, “Add an Electronic Signature (eSign) to a set of completed subject records.”. Click Sign to apply the electronic signature to the current page.

  13. Examine the 3 eSignature fields at the bottom of the page.

  14. Click > Page History to open the Page History window. The Page History is displayed, Click OK to close the window.

  15. Click > Logout to exit DFcollect.

18.14. Verify DFcollect saves eSignature task data to the specified level.

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

  2. Select View > List. Click 007 - Study Termination. Confirm DFVALID displays as "4" for subject 99011.

  3. Select File > Exit to close DFexplore.

18.15. End Module 18. DFcollect.

  • Return to the DFATK application. Click End to confirm successful completion of Module 18. DFcollect.

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