Characteristics of Trials Where Subject Level Data is Available for Each Site

Trials, for which subject level information is available for each site, display the following rollup characteristics:

• Subject enrollment information is automatically rolled up from the subject level to the site level, from the subject level to the region level, and from the subject level to the protocol level.

• When a subject is the first subject to enroll for a site, region, or protocol, the date in the First Subject Enrolled field for that site, region, or protocol, is automatically populated.

• When a subject is the last subject to complete or drop off the trial for the site, region, or protocol, the date in the Last Subject Off Study field for that site, region or protocol is automatically populated.

  When you terminate a site by entering a date in the Site Termination field, the date in the Last Subject Off Study field for the site is populated with the latest date in the Completed Date field or the Early Terminated Date field of all subjects that are associated with the site. Siebel Clinical verifies that the date in the Last Subject Off Study field is later than or equal to the date in the First Subject Enrollment field. For more information, see the Last Subject Off Study Date Rollup Status n user property in User Properties for Business Components in Siebel Clinical.

  Also, the Last Subject Off Study date is automatically rolled up from the site level to the region level and from the site level to the protocol level. For more information, see the Date RollUp Fields:Region n user property and the Date RollUp Fields:Protocol n user property in User Properties for Business Components in Siebel Clinical.