Summary

This article covers the contents and the functionalities of the edit monitoring template configuration form.

Table of Contents

• Display Header Text Button
  • Show Hidden Button
  • Move Question Order
• Add Sections or Fields
  • Section
  • Configurable Fields
  • Connection Fields
  • Add Configurable Field Dialog
  • Add Connection Field
  • Add Section
  • Delete Questions
• Edit Existing Configurable Questions

The Edit Monitoring Template Configuration form allows users the ability to add questions, change the order of questions and update existing questions to the monitoring template.

When completing each Edit Monitoring Template Configuration form you have the option of viewing the text that will be displayed for each question, the variables that will label the questions in reports and any questions that have a hidden visibility setting. To control these viewing options, use the Display Header Text and Show Hidden buttons.

Display Header Text Button

Header Text is the text that will label the question in reports. Click the Display Header Text button and each question’s Header Text will appear below each question. Click again (now labeled Hide Header Text) to toggle back to a hidden visibility state.

Question showing Header Text

Question not showing Header Text

Show Hidden Button

When the Show Hidden button is selected any question with a Visibility setting of Hide When Unused or Hide for All will display on the screen in grey. Click the button again (now labeled Hide Hidden) and any question with a Visibility setting of Hide When Unused or Hide for All will not display on the Edit Monitoring Template Configuration form screen.

Move Question Order

To move the order of questions on a form the user can click and drag a question up or down to change the location of the question on the screen.

Add Sections or Fields

A Monitoring Template can have Sections, Configurable fields, and/or Connection fields added to the template.

• A Section is a field in the form that can be used for spacing and/or section headers
• A Connection field is a field that connects with Fountayn EDC activity or CTMS study fields and populates data based on data in those fields.
• A Configurable field is a field that has to be manually answered in the template.

Section

While on the Edit Monitoring Template Configuration form the Actions menu will contain Add Section. When Add Section is selected the Add Section Dialog will appear to allow the user to configure a spacing and/or section header for the form.

Configurable Fields

While on the Edit Monitoring Template Configuration form the Actions menu will contain the Add Configurable Field. When Add Configurable Field is selected the Add Configurable Field Dialog will appear to allow the user to configure the question for the form.

Connection Fields

While on the Edit Monitoring Template Configuration form the Actions menu will contain the Add Connection Field. When Add Connection Field is selected the Add Configurable Field Dialog will appear with Pull Response Data From to allow the user to configure the connection question for the form. Data can be imported from other areas within CTMS or Fountayn EDC activity.

Add Configurable Field Dialog

The Add Configurable Field Dialog will contain the Question Text, Header Text, Visibility and Answer Type options.

1. Enter the label that needs to appear on the form in the Question Text Field.
2. Enter the label that needs to appear in reports in the Header Text Field.
3. The Visibility defines if the question will be visible on the forms and managers. If a question is displayed in a Manager and the question’s visibility is marked as Hide for All the question column will not appear in the Manager. The options for Visibility are:
   • Visible: The question will display on the form. This is the default setting.
   • Hide for All: The question will not display on new or existing forms, even if data is entered for the question on existing forms.
   • Hide When Unused: If the question exists on a form with data the question will appear. For all new forms created or existing forms with the question not answered the question will not appear.
4. For Configurable Fields the Answer Type question will appear. Select the type of answer option for the new question from the Answer Type dropdown.
5. The available for Answer Type are Text, Dropdown, Multi Dropdown, Date and Multi Document.
   • The default setting for Answer Type is Text.
6. When Dropdown or Multi Dropdown is selected the Answer Options section will appear.
7. Enter the text for the Answer Option.
   • To add an answer option select “Add Answer Option” and a new Answer Option row will appear.
   • To delete an Answer Option select the trash can and the row will be removed.
8. A Text Answer Type will provide a text field to enter the answer value.
9. A Dropdown field will provide a dropdown answer option that allows one answer option to be selected. The Dropdown answer option contains a search field to enter a value and the dropdown will narrow the answers to matches that contain the search value.
   
10. A Multi Dropdown will provide a dropdown answer options that allow multiple answer options to be selected. With each answer option selected an x appears by the option. To unselect an answer option hit the x.
11. A Date Answer Type will provide a date field with a date picker to select the date. The CTMS Settings for Date Format and Partial Dates Allowed will determine the date format and if partial dates can be entered.
12. A Multi Document Answer Type will provide a Document Field that allows the users to choose files to attach to the form. The Document field will allow files to be updated and removed after attachment.

Add Connection Field

1. Enter the label that needs to appear on the form in the Question Text Field.
2. Enter the label that needs to appear in reports in the Header Text Field.
3. The Visibility defines if the question will be visible on the forms and managers. If a question is displayed in a Manager and the question’s visibility is marked as Hide for All the question column will not appear in the Manager. The options for Visibility are:
   • Visible: The question will display on the form. This is the default setting.
   • Hide for All: The question will not display on new or existing forms, even if data is entered for the question on existing forms.
   • Hide When Unused: If the question exists on a form with data the question will appear. For all new forms created or existing forms with the question not answered the question will not appear.
4. Select the type of connection for the new question from the Answer Type dropdown. The available options are:
   • Data Populated based on CTMS data is:
     • Site Study Name will provide the Study Site Name for the Site the monitoring template is created for.
     • Active Personnel will provide a list of Personnel who are active on the study (based on their Start/Stop Dates defined for the study personnel [link to]) for the Site the monitoring template is created for.
     • Site Address will provide the Address for the Site the monitoring template is created for.
     • Sponsor will provide the name of the Sponsor as defined on the Add Study Form for the study.
     • Product will provide the Product Name as defined on the Add Study Form for the study.
     • Patient Status will provide a total number of patient records for each patient status defined in Visit Plans for each site based on their patient data. The date used for Patient Status is based on the Visit Data, if the status is a date field the date value is used, if not a date field the audit date is used.
     • Deviations will provide a listing of all deviations for the site that are not locked based on the Deviation Workflow.
     • Open Action Items will provide a list of action items remaining open at the end of the selected dates
     • Action Items Completed will provide a list of action items marked as ‘Complete’ within the period of the selected dates
     • Data Populated based on EDC data is:
     • List of Record ID Cleaned will provide the Primary and Secondary identifiers of any records with changed metadata status.
     • Number of Forms SDV will provide the number of patients, forms and questions marked SDV.
     • Number of Forms Data Reviewed will provide the number of patients, forms and questions marked Data Reviewed.
     • Number of Forms Frozen will provide the number of patients, forms and questions marked Frozen.
     • Number of Forms Locked will provide the number of patients, forms and questions marked Locked.
     • Number of Queries Created will provide the number of queries created.
     • Number of Queries Reopened will provide the number of queries that had status changes to Reopened.
     • Number of Queries Closed will provide the number of queries that had status changes to Closed.
     • Query IDs of Queries Created will provide the Query ID numbers of queries created.
     • Query IDs of Queries Reopened will provide the Query ID numbers of queries reopened.
     • Query IDs of Queries Closed will provide the Query ID numbers of queries closed.
     • Detailed Listing for Forms SDV will provide the record primary and secondary IDs, as well as the path to the form or question, for patients, forms and questions marked SDV.
     • Detailed Listing for Forms Data Reviewed will provide the record primary and secondary IDs, as well as the path to the form or question, for patients, forms and questions marked Data Reviewed.
     • Detailed Listing for Forms Frozen will provide the record primary and secondary IDs, as well as the path to the form or question, for patients, forms and questions marked Frozen.
     • Detailed Listing for Forms Locked will provide the record primary and secondary IDs, as well as the path to the form or question, for patients, forms and questions marked Locked.

Note: For the SDV, Data Reviewed, Frozen and Locked options, the value for patient, form and questions will be determined where the metadata status is applied.

Add Section

1. Select Add Section on the Actions menu.
2. Enter desired text or leave blank to add empty space
3. Select font size (if adding text)
4. Select section alignment preference (if adding text)
5. Select preferred color 
   

Note: PDF output will always be black and white.

6. Select divider sizing if divider preferred
7. Adjust padding (inside the divider line) and margins (outside the divider line) to define how large the empty space created by this section will be.
8. Select save on the Add Section dialog box

Note: Sections cannot be added above the top 3 default questions of a monitoring report.

Delete Questions

Each question on the Edit Monitoring Template Configuration form will have a delete icon to the right of the question until a version is activated. Once the template has been activated the Visibility settings should be used.

To delete a question using the Delete icon, select the icon.

A confirmation screen will appear. Select Delete to delete the question.

Edit Existing Configurable Questions

Users have the ability to update existing questions on the Monitoring Template form based on their need.

1. Select the edit () icon to open the Display Configuration Dialog.
2. The Display Configuration Dialog displays the Question Text, Header Text, Visibility and Answer Type values.
3. The Question Text Field can be updated to update the text that displays on the form.
4. The Header Text can be updated to update the label in reports.
5. The Visibility settings can be updated.
6. The Pull Response Data From can be updated.
7. The Answer Type can be updated to inform how data is captured.
8. The Answer Options for Dropdown and Multi Dropdown can have their values updated or update the visibility settings. If an answer option has been added and then needs to be removed from the options the Visibility setting should be updated. The options are:
   • Visible: This is the Default setting for all answer options. The answer option will display as an option for selection.
   • Hide When Unused: If the answer option has been selected on an existing template the answer option will still appear as the answer. For all new template forms created or existing templates with the answer option as an option and not answered the answer option will not appear.
9. Select Save to save the changed settings.

Note: For changes to appear in templates, the template must be activated before the changes are implemented for existing studies.

Need more help?

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