Annotated Case Report Forms

Run this report to generate blank case report forms with specific annotations and information about forms' names, question names, and validations associated with questions in forms.

Note:

When a kit is marked as Misallocated but it wasn't added to a visit in study design, that kit doesn't show in this report.

Modes

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

Permission required to run the report

Any user who's assigned the Run the Study Design Report permission can generate this report.

Filters

Filter	Description
Study version	Choose the study version to run the report for.
File Type	Choose the output type for the report: HTML or PDF.

Field descriptions

Note:

Fields that don't have any corresponding values are marked as N/A in the report.

Initial fields	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.
Asterisk (*)	Indicates that the item or question displayed in the report is required.
Check mark (✓)	Indicates that the item or question requires source data verification.
Hidden icon	Indicates that the item or question is hidden.
Report Generated By	User name of the user who generated this report.
Created Date	Date when this report was run.
Version Created	Date when the study version selected for this report was created.
Study Version	A study version's number.
Version Modified	UTC time and date of when the study version was modified.

Fields displayed for each form associated with the selected study version	Description
Form title	Indicates a form's title, reference code, as well as 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	A question's answer formats, such as text, date, multiselect (for drop-down questions), radio (for radio buttons), instructional text, and many more. Be aware that instructional text answers are not displayed in PDF versions of the Annotated Case Report Forms, and only appear in the HTML format.
Validations	A question's validation rules or rules related to dynamic questions and forms.
Advanced	A question's advanced properties such as SAS variables, SAS Labels, Lab Normals Tag, Data Classifications, Source Data Verification, Allow Future Dates.