External Column Mappings

Appear in parenthesis above or beside their corresponding control:

• The data mapping table name is concatenated to the column names. If a control is mapped to multiple data mappings, the path includes the data mapping name.
• If a control mapping includes a data label, the label follows the path after a forward slash.
• If a control mapping has a design note, a superscript follows the path, and the companion table for the external mapping includes the design note, identified by the same superscript

  Example:

  

External Mapping Companion Table

Appears labeled as such below the form. A companion table appears for each external mapping table that has form controls mapped to it. For an example, see Data mapping tables.

Selection/Element Values

Selection values for check boxes and radio controls in a group control appear in square braces in front of their corresponding controls. If the value is derived from the control definition (for example, the element value of a simple control), the value appears in italic font.

Selection value example:

Element values for pulldown controls appear in companion tables below the form. The pulldown control shows the title of the appropriate companion table.

Element value example:

Date Controls

Year ranges appear in parenthesis beside their corresponding control:

If a date control component allows an “unknown” value, “Unk” appears in the control:

Control/Unit Companion Tables

Appear below the form. For an example, see Unit lists.

Design Notes

• Form, section, itemset, and item design notes appear in tables following the form. All item notes appear in the same table (for example, see below).
• Design notes on a data mapping control definition appear in a Design Note column in the data mapping column table, identified by a footnote.

Item Not Required References

Denoted by an asterisk in the first column of the form (where the items/itemsets are numbered).

Client-Side Range Checks

The range check notation is displayed in the control.

Electronic Signature Affidavit

Appears below the form in the Annotated Trial Design view. For an example, Electronic signature affidavits.

Pulldown List References

The control contains a label that corresponds to a list in the companion tables following the form.

Text Box Specifications

Appear in the control:

• Data type and maximum character length for string data (text)
• numeric formatting information, including decimal places and significant digits if applicable, for numeric data (float)

Cover page

Appears when you select File, Annotated Trial Design and you have chosen to display it from the Annotated CRF Settings dialog box.

Sponsor Name
Protocol Name
Program Name
Therapeutic Area
Trial Note
Date/Time

Part of the cover page displayed when selected on the Annotated CRF Settings dialog box. A suggested use of the Trial Note is to provide a revision number on the cover page.