Chapter 3. Module 3. Study Setup

Table of Contents

3.1. Tests & Requirements
3.2. Begin Module 3. Study Setup.
3.3. Permitted users can gain exclusive access to DFsetup to modify a study setup.
3.4. Define Global study preferences and apply settings to DFsetup.
3.5. Create and modify a new style (Comment).
3.6. Create and modify a new module (Death).
3.7. Assign Field definitions to a newly created module.
3.8. Assign a module's field definitions to a plate.
3.9. Correct field ordering on the current plate to set field traversal order for data entry.
3.10. Use copy and paste to create repeating module and field references on a plate.
3.11. Create user-defined query category codes.
3.12. Submit a copy of the newly defined Plate 11 into the study database and retrieve the page in DFexplore Image View.
3.13. Enter and save all data on the submitted plate 11.
3.14. End Module 3. Study Setup.

3.1. Tests & Requirements

  1. Permitted users can gain exclusive access to DFsetup to modify a study setup.

  2. Define Global study preferences and apply settings to DFsetup.

  3. Create and modify a new style (Comment).

  4. Create and modify a new module (Death).

  5. Assign Field definitions to a newly created module.

  6. Assign a module's field definitions to a plate.

  7. Correct field ordering on the current plate to set field traversal order for data entry.

  8. Use copy and paste to create repeating module and field references on a plate.

  9. Create user-defined query category codes.

  10. Submit a copy of the newly defined Plate 11 into the study database and retrieve the page in DFexplore Image View.

  11. Enter and save all data on the submitted plate 11.

Estimate of Time Required: 20 Minutes

3.2. Begin Module 3. Study Setup.

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

  2. Click 3. Study Setup followed by Begin to begin this module.

3.3.  Permitted users can gain exclusive access to DFsetup to modify a study setup.

  1. 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.

  2. Start DFsetup, login as data_manager and choose 254 Acceptance Test Study as described in Section 1.8, “How to start DFsetup.

  3. 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.

  4. Select File > Preferences to open the Preferences dialog. Set:

    • Exit after __ minutes of inactivity = 5

    • Background Color = Color

    Click OK to save and close the dialog.

3.4. Define Global study preferences and apply settings to DFsetup.

  1. Select Study > Global Settings to open the Global Settings dialog. Click Global tab. Confirm that:

    • Study launched in the year = 1990

    • Reasons for data change are required = per field

    • Show next __ New Subject binders = 5

    • Check (enable) Enable New Subject creation

    • Uncheck (disable) Run Edit checks in View mode

    If these options are not set this way, modify them now and click Apply.

  2. Click Help. Enter Welcome to the Acceptance Test Study. For assistance please contact 1-XXX-XXX-XXXX.. Click Apply.

  3. Click Fields tab, and set:

    • Descriptions = 40 characters

    • Start year (for two digit years) = 1925

    • Imputation (for partial dates) = Never

    • Check (enable) Auto Generate Help

    • Uncheck (disable) Field Name must be unique across all module definitions

    • Do not edit Fill Color

  4. Click Levels tab. Confirm that the workflow labels of Level 0, Level 1, and through to Level 7 are used.

  5. Click Guides tab. Confirm/change:

    • Check (enable) Enable Snap

    • Check (enable) Display CRF

    • Check (enable) Display Fields

    • Set Maximum Box Height = 25

    • No changes are required to Colors Fields or Foreground

  6. Click User-defined tab. Confirm that all Property Values are blank.

  7. Click OK to save changes and exit the dialog.

3.5. Create and modify a new style (Comment).

  1. Select View > Styles from the menubar.

    [Note]Note

    The style names and information appearing in your Styles dialog may be different from those shown here. You should see the standard DFdiscover Simple styles.

  2. Within the DFsetup-Styles dialog, locate the style name SimpleString. Click SimpleString to select it as the current style. Click Clone to duplicate this style.

  3. Provide a Style name of Comment in the Style dialog and click OK.

  4. Click Comment to make it active, and confirm the Style Properties Basic tab displays the style properties as shown.

  5. Click Detail tab, Change the Store property from 1 to 200. Check (enable) the to the left of the Store property to lock this setting in the Comment style. Click Apply to apply the modifications. Click Done to close the Style Properties dialog.

3.6. Create and modify a new module (Death).

  1. Choose 10 - Death Report entry from the Plates-Modules-Fields list panel to make plate 10 the active plate. Select View > Modules to open the module definition dialog.

  2. Click Module options New.

  3. Enter a name of Death in the Add Module dialog. Click OK to save.

  4. With the Death module selected as the active module, confirm that the Name Death appears in the Module Properties window. In the Description field, enter Death Report. Click Apply.

3.7. Assign Field definitions to a newly created module.

  1. Choose Death module defined in Section 3.6, “Create and modify a new module (Death).” to make it the active module. Click Field options New.

  2. To create a field definition for “Cause of death”, choose Comment from the Style pull-down list, click OK.

  3. Enter the name DEATH for the Field Name: and click OK.

  4. Within the Field Properties, enter a Description of Cause of Death?. Click Apply.

  5. Click Field options New. In the resulting New Field Style dialog, choose S99 NO-YES from the Styles pull-down list. Click OK.

  6. Enter the name AUTOPSY for the Field Name: and click OK.

  7. Within the Field Properties, enter a Description of Was an autopsy performed?. Click Apply.

  8. Click Done.

3.8.  Assign a module's field definitions to a plate.

  1. Still with 10 - Death Report as the active plate, create the field references (layouts) for the Cause of death and autopsy fields defined in Section 3.7, “Assign Field definitions to a newly created module.”. First add the Death module to plate 10-Death Report by clicking Add from the Module options. Locate and choose Death module from the list of modules.

  2. Click OK to add the Death module to plate 10-Death Report.

  3. Click to the left of Death [1] module entry in the Plates-Modules-Fields list to show all field definitions within the Death [1] module.

  4. Create a field reference for the Cause of Death. Using the mouse, select Click the leftmost end of the second longest lines on the plate background. Holding down the left mousebutton and Control, drag up and across to the rightmost end of the line. Release the mousebutton to create a string field widget.

  5. Select the DEATH field in the Plates-Modules-Fields listing to assign a field definition.

  6. Create a field reference for the Was an autopsy performed? field. Using the mouse, click the middle of the No box on the plate background. Next click the middle of the Yes box on the plate background. This defines the position of each response option for the AUTOPSY field.

  7. Select the AUTOPSY field in the Plates-Modules-Fields listing to assign a field definition.

3.9. Correct field ordering on the current plate to set field traversal order for data entry.

  1. All fields are now defined on plate 10 - Death Report. Select Field > Order. In the dialog, sort the fields as shown, by using the arrow buttons.

  2. Click OK to apply the selected field order.

  3. Click to the left of 10-Death Report in the Plates-Modules-Fields list to collapse all plate 10 - Death Report modules.

3.10. Use copy and paste to create repeating module and field references on a plate.

  1. Click 11 - Weekly Patient Diary to make it the active plate. Scroll to view all module and field references on the plate.

  2. Click to the left of 11-Weekly Patient Diary to expand the list of modules defined on the current plate. Choose Diary[6] from the list.

  3. Click Copy from the Module options.

  4. Click Paste from the Module options.

  5. In the Paste Module fields dialog specify the substitution shown, which modifies the Alias and Description fields.

  6. Click OK in the Paste Module fields dialog to perform the paste operation.

  7. With the block of fields still highlighted, use the mouse to drag the block of field reference widgets and position them over top of their respective field outlines on the plate background. Click anywhere on the plate background to release the pasted block.

  8. One by one select each Diary[7] field reference widget. Examine the Field Properties window for each and confirm that the Alias and Description properties contain the correct substitution character of 7.

3.11. Create user-defined query category codes.

  1. Select View > Query Category Map.

  2. Click Add. The Code field is auto-filled with a value of 30. Press Tab to advance to the Label field. Enter Test for the Label field. Select Yes from the Auto-Resolve drop-down. Set Sort Order to 5.

  3. Click Add. The Code field is auto-filled with a value of 31. Without altering the code number, enter Monitor for the Label field. Select Yes from the Auto-Resolve drop-down. Set Sort Order to 3.

  4. Click Add. Without altering the code number, enter Clinical QC for the Label field. Select No from the Auto-Resolve drop-down. Set Sort Order to 10.

  5. Click Save followed by Done to close the dialog.

  6. Select File > Save [Required] to save all modifications. Click Save in the warning dialog. Select File > Exit to close DFsetup.

3.12. Submit a copy of the newly defined Plate 11 into the study database and retrieve the page in DFexplore Image View.

  1. To complete the remainder of Module 3. Study Setup, the Control Panel is needed. Start the Control Panel as datafax as described in Module 1 (Installation & Initialization).

  2. Click Send ID 99006 to email a copy of ID99006.pdf to site_monitor. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the ID99006.pdf 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 site_monitor to receive the module specific PDF files.

  3. Start DFsend and login as user site_monitor, as described in Section 1.9, “How to start DFsend.

  4. Click Add. From the Select PDF Files file selection dialog, locate the previously saved ID99006.pdf file. Select the file and click Open.

    [Note]Note

    Documents can also be added by dragging-and-dropping the desired PDF files from a local file folder into the list area.

  5. Click Send. In Verify Password dialog, enter site_monitor in the Username field and the previously assigned password in the Password field. Click OK.

  6. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  7. Click Show Log to review the DFsend transmission history.

  8. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

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

  10. Select View > Image.

  11. Do not change any settings in the Automatic Retrieval dialog, click OK to retrieve the image.

  12. Select Plate > Show Field Properties to display a listing of properties for all fields on the current page. Locate field numbers 46 to 51 that were created in Section 3.10, “Use copy and paste to create repeating module and field references on a plate.”. Verify the settings and click OK.

3.13. Enter and save all data on the submitted plate 11.

  1. Upon retrieval of plate 11-Weekly Patient Diary, the cursor is on the Study Week # field. Enter the Study Week # value as it appears on the CRF image. Note that a prefix of 2 is hardcoded in the Study Week # field so that the resulting value will appear as 201. Press Tab to advance to the Patient Number field.

  2. Enter the Patient Number as it appears on the CRF image. Press Tab to move to the Patient Initials field. Enter ANK as per the CRF image and press Tab to advance to the next field.

  3. Starting with the Check this box... field, enter all data for 11-Weekly Diary Report as it appears on the CRF image in the lower half of the split-screen window. Press Tab to move from field to field until field 6. My blood pressure today is the current field. Leave the field blank as per the CRF image and press Tab. The Add Query dialog is presented.

  4. Click Cancel in the Add Query dialog to close the dialog. The 2nd blood pressure field (diastolic) gets the focus. Leave the field blank as per the CRF image and Tab off the field. Again, click Cancel in the resulting Add Query dialog.

  5. Enter the remaining fields on Plate 11-Weekly Patient Diary as per the CRF image. Once a value has been entered in the last VAS field (7. My energy level today), press Tab. This makes the save buttons active at the bottom of the data record.

    [Note]Note

    During document submission, the ICR may fail on one or more of the fields on the Plate 11-Weekly Patient Diary page. You will need to enter values into those fields that have been missed or misread by the ICR. To correct VAS scales, make the desired VAS scale the current field on the data record. Locate the corresponding VAS scale on the CRF image. Using the left mouse button, select the leftmost end of the scale, followed by the intersection point, and then the rightmost end of the scale on the CRF image.

  6. With the focus on the save buttons, click Final to save the record to the database with the status Final.

  7. Select File > Exit to close DFexplore.

3.14. End Module 3. Study Setup.

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

  2. Click End to confirm successful completion of Module 3. Study Setup.