Annotated Case Report Forms

Modes

Available in all 4 modes: Design, Testing, Training, and Production.

Permission required to run the report

Users assigned with a study role that includes the Run the Study Design Report permission can generate this report.

Filters and Settings

Use the filters and settings below to select which forms you would like to include in the report output.

Filter/Setting	Description
Study version	Select a study version to include all forms from all visits in the report for that study version. Then, if applicable, use the Visit and Form filters to select specific forms. Note: The Visit and Form filters become active after you select a Study Version.
Visit and Form 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	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 included in this section. Form Preview: Leave this setting enabled if you want to include a visual representation of the selected forms in the report. 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.
File Type	Select HTML or PDF as the file output type for the report. Note: If the Form Preview setting is enabled, you can only generate the report in HTML.

Details about the report header

Fields with no corresponding values are marked as N/A in the report.

Field	Description
Customer Name	A customer's name used to purchase the cloud subscription.
Study Name	A study's ID as entered by the study manager when they created the study.
Mode	The mode in which you ran this report.
Report Generated By	The user name of the user who generated this report.
Created Date	The date when the report was run.
Version Created	The date when the study version selected for this report was created.
Version Modified	The UTC time and date of when the study version was modified.
Study Version	The version of the study selected when the report was generated.
Visit	Lists the visits selected under the Visit filter. The report only includes this row if you make a selection.
Form	Lists the forms selected under the Forms filter. The report only includes this row if you make a selection.
Included in Report	Lists the settings (Forms by Visit, Form Preview, and Form Annotations) if enabled when the report is generated.

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 correct 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.

Whether you include the Form Preview details or not, the following information is provided for each form included in the report.

Fields displayed for each form associated with the selected study version	Description
Form title (header)	Indicates a form's title, reference code, type, and the visits and branches to which the form was assigned. For a lab form, this row also indicates whether a site user is allowed to add additional instances of the same lab form during the course of a study. When applicable, the text displayed states "Allow for Multiple Instances". For a form with label items, this row also indicates whether a site user is allowed to add additional rows in the form. When applicable, the text displayed states "Allow Additional Rows".
Question	Indicates a question's title, as well as the question's hint, or instructional text, if applicable.
Reference ID	A question's reference code.
Answer	Provides a question’s type, such as Date or Multiselect, a list of options when applicable, instructional text, and details about the question, for example, character count (200) for a text question and the date format (DD-MON-YYYY) for a date question. If a code list is used, this column also includes details like code list title and the code list values.
Validations	A question's predefined rules, added in form design. These are validation rules, rules related to dynamic questions and forms, or Auto-lock rules. For validation rules, the type (Validation, Validation and Query, or Query) is appended to the front. For example: Rule 1: Validation and Query: Exactly 1.
Advanced	A question's advanced properties such as SAS variables, SAS Labels, Lab Normals Tag, Data Classifications, Source Data Verification, Allow Future Dates, what Randomization and Trial Supply Management (RTSM) action(s) the question is required for, and EHR mapping details. For more information, see About mapping questions for Electronic Health Record (EHR) data import. Can also contain a question's safety properties, such as E2B(R3) mapping, Required for Case Creation, or Trigger a Follow Up Case. For more information, see About collecting adverse event data. Questions that are modified through an Advanced Study Versioning (ASV) update display details of that change performed by a study designer, including non-label questions that are part of a tabular form. For example, you may see: Apply Change to Study Version: 1.0.0.4 P01-123-A3.