Chapter 4. Module 4. eCRF Creation for DFdiscover

Table of Contents

4.1. Tests & Requirements
4.2. Introduction
4.3. Begin Module 4. eCRF Creation.
4.4. eCRF creation in DFsetup.
4.5. eCRF background color preferences.
4.6. Entering eCRF data.
4.7. End Module 4. eCRF Creation.

4.1. Tests & Requirements

  1. eCRF creation in DFsetup.

  2. eCRF background color preferences.

  3. Entering eCRF data.

Estimate of Time Required: 20 Minutes

4.2. Introduction

This module utilizes Electronic case report forms (eCRFs) which you will create using DFsetup without a PostScript® or PDF file. eCRFs do not contain barcodes and are therefore only suitable for entry via EDC.

4.3. Begin Module 4. eCRF Creation.

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

  2. Click 4. eCRF Creation 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.

4.4. eCRF creation in 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 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.

  3. Select Study > Add eCRF Plate. In the Add eCRF Plate dialog enter a New Plate Number of 21. Click OK.

  4. In the Plate Properties set:

    • Label = Lab Results

    • eCRF = Yes

    • Sequence is = predefined

    • Triggers Early Termination = No

    • Eligible for Signing When = Final

    Click Apply.

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

  6. Double-click the 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.

  7. 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.

  8. Click LB1 [1] Module, drag the module onto the eCRF. Select Field > Group.

  9. Click LB2 [1] Module, drag the module onto the eCRF. Select Field > Group.

  10. Click LB3 [1] Module, drag the module onto the eCRF. Select Field > Group.

  11. Select File > Save [Required].

  12. Select File > Exit to close DFsetup.

4.5. eCRF background color preferences.

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

  2. 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 site_monitor previously used DFexplore and modified user preferences, you may see a different background than what is illustrated below.

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

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

  5. Enter HTML:#66EEEE.

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

4.6. Entering eCRF data.

  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 as the current eCRF, click Patient Initials. The initials are pre-filled as a result of the edit check SetInit described in Module 8. Image 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.

4.7. End Module 4. eCRF Creation.

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

  2. Click End to confirm successful completion of Module 4. eCRF Creation.