Include a form preview in the Annotated Case Report Forms report

You can now include a visual representation of study forms in the Annotated Case Report Forms standard report.

New filters and settings have been added to the Annotated Case Report Forms standard report that allow you to include a visual representation of study forms in the report. You can also include a section that provides a list of visits and the associated forms.

Details for study designers

Including a visual representation of the forms in your study, along with a list of the forms per visit, can be useful for several reasons.

You can distribute your study design to the individuals responsible for designing downstream integrated systems that are intended to consume data from an Oracle Clinical One Platform study.
You can circulate the report to facilitate the review and approval process to secure study design sign-off.

Details for report users

Users assigned with a study role that includes the Run the Study Design Report permission can use the new filters and settings below, located on the Settings sidebar, to generate the report.

Table 2-1 New report filters and settings

Filter/Setting	Details
Study Version	This is an existing filter that allows you to select a study version. Use this filter and the new filters and settings below, if applicable, to include specific forms in the report. Note: The Visit and Form filters become active after you select a Study Version.
Visit and Form filters (New filters)	If you want to include all forms from all visits for the selected study version, leave both the Visit and Form filters set to All (default). If you want to include the forms from specific visits (for the selected study version), select the applicable visits in the Visit filter. Note: Visits included in a branch are prefixed with the branch name in the Visit drop-down, making it easier to identify the correct visit if they share the same visit name with a visit in another branch. If you want to include specific forms from the visits selected (for the selected study version), select them from the Form filter. Tip: You can also leave the Visit filter blank and select specific forms from the Forms filter. If you use both the Visit and Form filters, the report output only includes those forms that are associated with the selected visits. For example, a study's design includes the following visits and forms. The Screening visit includes the Screening form. The Baseline visit includes the RTSM and Vitals forms. The Week-1 visit includes the Vitals form. If Week-1 is selected under the Visit filter and RTSM is selected under the Form filter, no forms are included in the report. If Baseline is selected under the Visit filter and the RTSM and Screening forms are selected under the Form filter, only the RTSM form is included in the report.
Include in Report (New settings)	Use the following settings (enabled by default) to determine which sections to include in the report. Note: Form Annotations, defined below, are included in the report output (by default) if you disable all three settings. Forms by Visit: Leave this setting enabled if you want to include the Forms by Visit section in the report, which lists each visit and its associated forms based on the study version selected. This section appears below the main report header and above the Forms section. Note: The Visit and Form filters, if applied, have no impact on the content displayed in this section. Form Preview: Leave this setting enabled if you want to include a visual representation of the selected forms in the report. Note: If enabled, you are only able to generate the report in HTML. Each form preview is included in the Forms section immediately below the form name and above the form annotations, which includes the questions, reference IDs, answers, validations, and advanced setting details. Form Annotations: Leave this setting enabled if you want to include the form annotations, which include the questions, reference IDs, answers, validations, and advanced setting details in the Forms section of the report.

Filter/Setting

Details

Study Version

This is an existing filter that allows you to select a study version. Use this filter and the new filters and settings below, if applicable, to include specific forms in the report.

Note: The Visit and Form filters become active after you select a Study Version.

Visit and Form filters (New filters)

If you want to include all forms from all visits for the selected study version, leave both the Visit and Form filters set to All (default).

If you want to include the forms from specific visits (for the selected study version), select the applicable visits in the Visit filter.

Note:
Visits included in a branch are prefixed with the branch name in the Visit drop-down, making it easier to identify the correct visit if they share the same visit name with a visit in another branch.
If you want to include specific forms from the visits selected (for the selected study version), select them from the Form filter.
Tip: You can also leave the Visit filter blank and select specific forms from the Forms filter.

If you use both the Visit and Form filters, the report output only includes those forms that are associated with the selected visits.

For example, a study's design includes the following visits and forms.

The Screening visit includes the Screening form.
The Baseline visit includes the RTSM and Vitals forms.
The Week-1 visit includes the Vitals form.

If Week-1 is selected under the Visit filter and RTSM is selected under the Form filter, no forms are included in the report.

If Baseline is selected under the Visit filter and the RTSM and Screening forms are selected under the Form filter, only the RTSM form is included in the report.

Include in Report (New settings)

Use the following settings (enabled by default) to determine which sections to include in the report.

Note: Form Annotations, defined below, are included in the report output (by default) if you disable all three settings.

Forms by Visit: Leave this setting enabled if you want to include the Forms by Visit section in the report, which lists each visit and its associated forms based on the study version selected.
This section appears below the main report header and above the Forms section.

Note: The Visit and Form filters, if applied, have no impact on the content displayed in this section.
Form Preview: Leave this setting enabled if you want to include a visual representation of the selected forms in the report.
Note: If enabled, you are only able to generate the report in HTML.

Each form preview is included in the Forms section immediately below the form name and above the form annotations, which includes the questions, reference IDs, answers, validations, and advanced setting details.
Form Annotations: Leave this setting enabled if you want to include the form annotations, which include the questions, reference IDs, answers, validations, and advanced setting details in the Forms section of the report.

Details about the Forms by Visit section

The report only includes this section if the Forms by Visit option is enabled under the Include in Report setting during report generation. When included, it provides a listing of all forms per visit, based on the study version selected.

The Visit and Form filters have no impact on the content displayed in this section.
Forms included in a visit multiple times are listed once, as the section provides a list of unique forms per visit.
Forms that are part of a visit branch appear only once regardless of the number of cycles defined, as the table only includes the first instance of each cycle.
For example, a study's design includes two visit branches: Branch 1 Male and Branch 2 Female, where Branch 1 Male consists of Day 1, Day 15, and Day 30 visits with a maximum of 5 cycles.

In this scenario, the following details are included once in the Forms By Visit section, where each branch-visit combination and the associated forms are displayed under a separate header.

Branch 1 Male - Day 1

Each unique form for Day 1 is listed.

Branch 1 Male - Day 15

Each unique form for Day 15 is listed.

Branch 1 Male - Day 30

Each unique form for Day 30 is listed.

Details about the Forms section

If the Form Preview setting under Include in Report is enabled, a visual representation of each form selected during report generation is included in this section.

All form types are supported. Repeating and two-section forms are displayed as flat forms, but the header indicates the form type.
Dynamic forms and questions are displayed.
Hidden questions are displayed
The Select Lab drop-down, which is present on lab forms and contains a list of existing labs, is included in the Form Preview, but the drop-down is empty.
The report flattens Question Group type questions, positioning the question on the left and the answers on the right.

You can find additional information in the Reporting Guide (Annotated Case Report Forms) after the Release Assessment Environment (RAE) upgrade.

Parent topic: Reporting, archives and analytics