Summary

This article is an overview of the missing forms report.

Table of Contents

• Filters
  • Subject
  • Site
• Results Table
  • Form/Path
  • Expected Total
  • Expected but Blank
  • Overdue Days
  • Expected and Entered
  • Entered Within Window
  • Days Late
  • Site
  • Patient
• Export
• Configuration of Missing Forms Report
  • Access Report Configuration
    • This Form is Expected
    • Days
    • After
  • Configuration for Dynamic (Log) Forms

The Missing Forms report displays the total count of forms by study, site, and subject that are expecting data entry based on the trial configuration. These totals are divided into expected forms that are blank, and expected forms that have data entered. Additionally, the report shows how overdue the expected but blank forms are and how timely the expected and entered forms were completed. The projections for expected dates are based on the configured Visit Manager windows by default, but can be modified by roles enabled to configure the report.

A blank form is defined as one that has never been saved, meaning that no questions on the form have an audit trail entry.

To access the Missing Forms report, or any other standard report, hover your cursor over the ‘Reports’ option in the Navigation menu from within any EDC study and select ‘Missing Forms’.

Filters

By default, users with a role enabled to view the Missing Pages report will see the report results across all subjects visible at the site level they are accessing. For example, a Monitor accessing the study at an individual site will only see results for that site. However, a Monitor accessing the study at the All Sites level will by default see report results for the entire study, Results can be further filtered by Subject and Site.

Subject

Select Primary or Secondary Identifier from the Subject dropdown (values will vary from study to study but will typically include Subject ID). Enter the appropriate search value, for example the Subject ID you wish to filter for.

Site

Use the Site menu to view the report for a specific site. For example, a Monitor accessing the study at the All Sites level can filter to view results for Site 01 only.
After applying search options, click the Search button to rerun the report using those settings. Click Reset to return to the default view.

Results Table

The report results will display in a table, with a series of expandable rows. Initially, a single row will appear with cumulative totals according to the filtered settings. Click the + sign to expand the table to view totals by site, by subject, and for individual subject forms.

Values in each column will be displayed as follows:

Form/Path

When viewing the report expanded to subject form level, this column will display the Path and Name of the form. Note, this column will only show forms that currently exist for that subject. For example, if Visit 2 has not yet been created for the subject, Visit 2 forms will not be displayed in the report, even if the expected window for entry has passed.

Expected Total

Displays the total number of forms at that level that are expected to be entered based on the configured visit projections. In the screenshot above, 24 indicates the number of forms at Site 02 that are expected to be entered now. 12 indicates the number of forms expected to be entered for Subject 04-100 (KMT), and 1 indicates there is 1 instance of each displayed individual form expected to be entered for that subject.

Expected but Blank

Displays the number of forms at that level that are expected to be entered but are blank.

Overdue Days

At the Site and Subject level, this displays in the format X – Y, where X represents the total number of expected but blank forms at that level and Y represents the total combined number of overdue days for those forms. At the individual form level, this displays a number to indicate the number of days that specific form is overdue.

Expected and Entered

Displays the total number of forms at that level that are expected to be entered and have been entered. Note – An entered form is defined as one that has been saved.

Entered Within Window

At the Site or Patient level, this column will display the percentage of Expected and Entered forms that were entered (saved) within the expected date window. At the individual form level, Yes or No will display to indicate whether or not that individual entered form was entered within window.

Days Late

At the Site and Subject level, this displays in the format X – Y, where X represents the total number of forms that were entered late at that level and Y represents the total combined number of late days for those forms. At the individual form level, this displays a number to indicate the number of days that specific form was late in being entered.

Site

When viewing at the subject or individual form level, this column will display the site the data is pulling from.

Patient

When viewing at the individual form level, this column will display the Primary and Secondary Subject Identifiers.

Export

Export the report values using the Excel or CSV links found in the Actions menu.

Configuration of Missing Forms Report

By default, the Missing Forms report will utilize the programmed Visit Manager windows to project when a form is due for completion. User roles enabled with the permission to configure the Missing Forms report can modify the default configuration as well as add due date expectations for forms that are not included in the Visit Manager configuration.

Access Report Configuration

From the Missing Forms Report screen, select the link to Configure Report, found under the Actions menu.

The configuration will default to using the Visit Manager visit window configuration (where present), but can be modified on a form by form basis. The following columns are present:

This Form is Expected

This column lists all forms in a subject casebook, with path and variable information.

Days

The cells in this column will default to inactive for forms that have a Visit Manager configuration. For other forms, a number of days can be entered in the active cell.

After

This column will default to the Visit Manager configuration, indicated by “Use visit configuration” followed by the programmed visit window. For example, “Use visit configuration (#v1.ie.infocons + 21|D)” indicates that the form is expected to be entered within 21 days after the Informed Consent Date. The field also contains a drop-down menu of every date question that appears on a static form in the casebook, allowing you to configure your own window. Selecting one of the date questions will activate the ‘Days’ field for that row.

Configuration for Dynamic (Log) Forms

All dynamic (log) forms such as Unscheduled Visits, Adverse Events, etc. will appear at the bottom of the form list under This Form is Expected. Configurations can be added in the same manner as described above. When expected windows are configured for dynamic forms, they will be evaluated for all instances of the dynamic form in the casebook.

Note: The dynamic (log) Protocol Deviation form is configured with an expected window of 90 days after the Informed Consent Date.

When users run the Missing Forms Report, every instance of the Protocol Deviation form that has been created for subjects will be listed in the report and will be counted as ‘Expected but Blank’ if it is more than 90 days after the Informed consent date.

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