Schedule of Events table in the Annotated Study Book

Element

If the study design uses study elements, they appear in the first row, and the study events in each study element are grouped under the study element columns.

Note: The study element name for the special Screening and Enrollment visits is System.

Assessment

Study events are listed in study workflow order, as they appear in the workflow editor for the study design or study element.

The heading of each visit column shows the study event title, short title (in parentheses), and visit type (in square brackets).

Visit types:

• S—Scheduled
• D—Dynamic
• U—Unscheduled
• R—Repeating

CRF

Short title of each form, or blank if the ShortTitle property is not defined.

Visit Start Hours

The visit start hour appears for study events. The visit start hour is a calculated value based on the scheduling specified for the study workflow.

The start hour for the special Screening and Enrollment visits is zero. If the first visit after the Screening and Enrollment visits is not scheduled in the study workflow, its start hour is also zero.

Forms

• Identified with their translated names in the language in which the annotated study book is generated. If the translated name is not specified, the form title appears. This form identifier also appears on each annotated form in the annotated study book.
• Forms are listed in study workflow order, except that:
  • Forms that occur in more than one visit are not duplicated.
  • If a study design includes a Regulatory Documents or Visit Report form, those forms appear in the form listing but do not appear in the Time and Events table.

A number in each visit column where the form appears indicates the order in which the form occurs in the visit.

Special form types are indicated by a code that follows the form order number:

• C—Common
• DF—Dynamic
• RF—Repeating

Key

Codes used for special types of forms and visits.