Chapter 15. Module 15: eCRF Creation for DFdiscover

Table of Contents

15.1. Tests & Requirements
15.2. Introduction
15.3. Begin Module 15.
15.4. eCRF creation in DFsetup.
15.5. eCRF background color preferences.
15.6. Entering eCRF data in DFexplore.
15.7. End Module 15.

15.1. Tests & Requirements

  1. eCRF creation in DFsetup.

  2. eCRF background color preferences.

  3. Entering eCRF data in DFexplore.

Estimate of Time Required: 20 Minutes

15.2. Introduction

This module utilizes the use of Electronic case report forms (eCRFs) which you will create within DFsetup without needing to import a PostScript® or PDF file containing the form background image. eCRFs do not contain barcodes and are therefore only suitable for entry via EDC.

15.3. Begin Module 15.

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

  2. Click Module 15 followed by Begin to begin this module.

  3. This module requires user valid1 to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

15.4. eCRF creation in DFsetup.

  1. Start DFsetup.

  2. In the DFsetup login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Highlight 254 Acceptance Test Study and click OK. 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.

    [Note]Note

    The main DFsetup window displays the last plate to be active in the user's previous DFsetup session. For this reason, you may see a different plate from what is displayed in the above illustration.

  4. Select Study > Add eCRF Plate... in the DFsetup - Add eCRF Plate dialog enter a New Plate Number of 21. Click OK.

  5. In the Plate Properties set:

    • Label = Lab Results

    • eCRF = Yes

    • Sequence is = predefined

    • Triggers Early Termination = No

    • Eligible for Signing When = Final

    Click Apply.

  6. Within Plates-Modules-Fields Module options Click Add, Check Keys, LB, LB1, LB2, LB3 modules, click OK.

  7. Double-click Keys [1] module to expand the list of fields. Using your mouse, click and drag the SUBJID and PINIT fields onto the 21: Lab Results eCRF.

  8. Click LB [1] Module, drag the module onto the eCRF, select LBORRES_n, LBNRIND and LBCLSIG_c fields by holding Shift and clicking on the fields. Select Field > Group.

  9. Click LB1 [1] Module, drag the module onto the 21: Lab Results eCRF. Select Field > Group.

  10. Click LB2 [1] Module, drag the module onto the 21: Lab Results eCRF. Select Field > Group.

  11. Click LB3 [1] Module, drag the module onto the 21: Lab Results eCRF. Select Field > Group.

  12. Select File > Save.

  13. Select File > Exit to close DFsetup.

15.5. eCRF background color preferences.

  1. Open DFexplore.

  2. In the DFexplore login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. In the DFexplore login dialog, select 254 Acceptance Test Study in the list of studies. Click OK to open the 254 Acceptance Test Study.

  4. Click Site 99 - Hospital #99 > Subject 99008 > 1: Baseline > 21: Lab Results to make it the active page.

    [Note]Note

    DFexplore stores previously defined user preferences. If valid1 previously used DFexplore and modified user preferences. You may see a different background than what is illustrated below.

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

  6. Select File > Preferences > Data Window, within eCRF background color, click to open the Select Color window.

  7. set HTML:#66EEEE.

  8. Click OK to close the Select Color window, click OK to apply your color preferences.

15.6. Entering eCRF data in DFexplore.

  1. Click within the Patient Initials field to display the field level help. Click to close the help dialog.

  2. With subject 99008 21: Lab Results still as the current eCRF. Click Patient Initials the initials automatically occupy this field as a result of the edit check SetInit described in Module 5: Fax Data Entry, set:

    • Collection Date = 27-SEP-2018

    • White Blood Cell = 18.8, Check (enable) Abnormal.

    • Red Blood Cell = 4.7, Check (enable) Normal

    • Hemoglobin = 18.5, Check (enable) Normal

    • Mean Cell Hemoglobin Conc = 40.2, Check (enable) Normal

    Click Final to save the data record.

  3. Select File > Exit to close DFexplore.

15.7. End Module 15.

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

  2. Click End to confirm successful completion of Module 15.