Annotated Study Book Options dialog box

Select Display Options section

• No Annotated Information—Form previews without annotations.
• Selected Annotated Information—Only the selected annotation information. If you choose Selected Annotated Information, select the specific information to include in the checkboxes that appear under that radio button.
• All Annotated Information—All annotated information.

Time and Events Schedule

A listing of the Schedule of Events table.

Forms

Selected information about each form in the study.

Inline CRF annotations

• If selected—The annotations described below.
• If not selected—Titles or RefNames that appear in square brackets.

The annotated forms display RefNames if Show Object RefNames is selected and titles if Show Object RefNames is not selected.

Item formats

• Text—A plus maximum character length (for example, A128).
• Integer—N plus maximum field length (for example, N3).
• Float—Significant digits and decimal places. The decimal point is included as a character in the length of an item. For example, if the length of a float item is 5 and the precision is 0, the annotation appears as xxxx. (the decimal point appears).

Captions on compound items

A caption for the parent item of a compound item appears with the alignment specified on the Layout tab.

Hidden, ReadOnly, or Editable display overrides

The word hidden, read-only, or editable appears in square brackets below the item question.

Minimums and maximums for integer and float items

Specifications set in the MinProperty, MinValue, MaxProperty, and MaxValue item properties are represented as values and operators and listed along with the item format. For example, the notation is 2.0 <= xx.xx < 100.0 if:

• MinProperty—GREATERTHANEQUAL
• MinValue—2.0
• Float length—5
• Float precision—2
• MaxProperty—LESSTHAN
• MaxValue—100.0

Date time items

Required and unknown specifications appear in the date and time controls, and year ranges appear in parentheses following the controls.

Required items

An asterisk appears after the item number. In the grid view of fixed repeating sections, an asterisk appears in the column header for each required item.

Items that require source verification

For an item in a form or non-repeating section, a check mark appears under the item number.

Repeating sections that require source verification

A check mark appears in the following locations:

• For a repeating section—Under the number in the repeating section header row.
• For a fixed repeating section—Under the # symbol in the fixed-item section header.

Items that are critical for source verification

For an item in a form or non-repeating section, a check mark inside a circle appears under the item number.

Items that are source-verification critical are also source-verification required, so these items show only the check mark inside the circle and not an additional check mark denoting their source-verification required status.

A footnote indicates that settings for critical source verification that are made in the InForm application override settings made in the Central Designer application.

Collapsible items

A collapsible item icon () appears after the item RefName.

Note: In the InForm application, a collapsible item is called a dynamic control.

Key items

A key icon appears under the item number.

Base units

A superscript b in square brackets appears to the right of the control for the base unit.

Repeating forms and sections

A summary item layout containing top-level items appears (for example, the children of compound items and conditional items do not appear), followed by a form layout.

Fixed repeating sections

A fixed item icon () appears after the item number.

The following views appear:

• Grid view containing a column for each top-level item and, for each fixed item, a row for each combination of item and codelist items. Depending on the definitions that exist in the study, column headers show the short question in the specified locale, the long question in the specified locale, or an empty cell.
  • For a hidden item, the text in the column header is grayed out.
  • The cell for a blank instance of a fixed or non-fixed item is grayed out and includes a blank icon ().
• Data entry preview containing controls for each fixed item.

Associated forms

The name of the associated form, if it exists, appears at the bottom of the annotated form.

Codelist Values and Tables

Annotations on forms for codelists that are formatted as radio or checkbox groups. The data type and value appears in square brackets and italic font to the left of each option (for example, [N:1] indicates an integer data type and a codelist item value of 1). Data types are:

• A—Text
• F—Float
• N—Integer

Additionally, the annotated study book includes tables that list the specifications of each codelist and codelist item along with the title or RefName of the item with which they are associated.

The tables display RefNames if Show Object RefNames is selected and titles if Show Object RefNames is not selected.

Include All Codelist Control Types

Available if Codelist Values and Tables is selected:

• If selected—The codelist tables include all formats of codelists.
• If not selected—The codelist tables include only codelists that are formatted as a drop-down list.

Study Object Description Tables

Tables that list the type (Form, Section, or Item), title or RefName, and description for each form, section, and item.

The tables display RefNames if Show Object RefNames is selected and titles if Show Object RefNames is not selected.

Only Show Properties With Values

Available if Study Object Description Tables is selected. If selected, the study object description tables list only study objects that have descriptions.

Note: If you select All Annotated Information, Only Show Properties With Values is not available.

Key Items Tables

Tables that list the following information for items in a repeating form or section that are defined as key items for navigation assistance (repeating forms only) or to enforce data uniqueness:

• Item name.
• Uniqueness (None, Individual, or Group).
• Order in which the items appear in the drop-down summary list of a repeating form.

The tables display RefNames if Show Object RefNames is selected and titles if Show Object RefNames is not selected.

Coding Summary Tables

Tables that list verbatim, dictionary, coding item, and context item data for each item on a form that is coded.

The tables display RefNames if Show Object RefNames is selected and titles if Show Object RefNames is not selected.

RDE Analytics Tables

Tables that display the titles or RefNames, database table column names, and database types that are generated in the InForm Reporting Database Extract (RDE) Analytics offering for each data entry object in a form. The format of each table column name consists of the RefName of the item or the RefName plus a suffix that depends on the type of item and the format of the data entry control.

The Data Variable column of the RDE Analytics tables displays RefNames if Show Object RefNames is selected and displays titles if Show Object RefNames is not selected.

Data Series Summary Tables

Tables that list the following information for each data series that has mappings for items contained in the form:

• Item number, based on the order of the item in the form.
• Item title or RefName, depending on whether Show Object RefNames is selected.
• Mapping RefName.
• Data set alias if available, otherwise RefName.
• Data series alias if available, otherwise RefName.
• Data series type.

Display Forms in Workflow Order

• If selected—Forms appear in study workflow order, except that:
  • Forms that occur in more than one study event are not duplicated.
  • Nonclinical forms (Regulatory Documents and Visit Reports) appear at the end of the listing.
• If not selected—Forms appear in alphabetical order.

Note: In the Time and Events Table, forms always appear in workflow order, regardless of the setting of the Display Forms in Workflow Order option.

Display Hidden Items

• If selected—Hidden items are included.
• If not selected—Hidden items are not included. If a form contains one or more hidden items, the footer of the table indicates that hidden items on the table are not displayed.

InForm Special Properties Table

A table that lists the values of the InForm Special Visit, Special Form, and Special Item properties, along with the property type and the study objects to which the properties are assigned.

If a special property has not been assigned to a study object, the table shows the value as Unassigned.

Personal/Protected Health Information Table

A table that lists each item in the study for which the PHI custom property is set to True, along with the section (if the item exists in a section) and form on which the item exists.

Unit Conversions Table

A table that lists the unit type and unit conversion formulas for items that have units and appear in one or more forms.

Review States Table

A table that lists information about the review states defined for the study, along with information about the review stages defined for each review state. If a review state is not activated, only the review state header appears.

If translations are missing for one of the product locales but present for the other, the locale for which translations have been defined appears in the table in the place of the other locale. An asterisk and footnote appear for translations that have been replaced in this manner.

Show Object RefNames

• The annotated study book uses study object RefNames, rather than titles, to identify study objects. The following areas are affected:
• The RefName for a form or section is appended to the form or section title that is displayed in the annotated form header. RefNames are enclosed in square brackets.
• In annotated forms, items are identified with RefNames.
• With the following exceptions, data tables that follow the annotated form use a column header of RefName instead of Title, and the column contains RefNames.
  • The Time and Events table is not affected by this option.
  • The Data Series Summary Table always uses RefName to identify mappings and data sets, regardless of whether this option is selected.

Select Cover Page Options section

Include Cover Page—Cover page with the study design properties selected from the Display the following in addition to the study title list, along with the study design title.

If you select a user-defined custom property, the property must have a value and be visible, or it does not appear on the cover page.

Do Not Include Cover Page—No cover page.

Note: The values of cover page options are set in the Properties Browser for the study design.

Select Date Variable Format

Format of date time items in the annotated forms.