Annotated Case Report Forms

This report provides information about the forms in your study. It presents each form with its questions and answers, as well as validation details and advanced settings. You can also include a visual representation of all or some forms in the report output and a listing of forms by visit.

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	Select the study version you want to generate 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	The user name of the user who generated this report.
Created Date	The date when this 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.

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	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.

Parent topic: Report descriptions