About Rolling Up Information for Subject Enrollment

Siebel Clinical supports clinical organizations in better managing subject enrollment for their trials in real-time. To implement this tracking, subject information is rolled up from the site level to the region level and then to the protocol level or directly from the site level to the protocol level. However, frequently this data is not available to the clinical organization, which presents significant business challenges.

For example, if organizations out source trials to CROs (clinical research organizations), then the clinical organizations cannot always receive subject level information. The enhanced subject rollup functionality provides accurate subject enrollment data at the region and protocol level, when subject level information is not available for each site or region.

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".

Characteristics of Trials Where Subject Level Data is Not Available for Each Site

Trials, for which subject level information is not available for a site, display the following characteristics:

• You can select the No Subject Info field for sites that do not have subject level information.

• CRAs (clinical research associates) can enter information in the following fields for sites that do not have subject or site level information:

  • # Screened

  • # Re-Screened

  • # Screen Failure

  • # Enrolled

  • # Completed

  • # Early Terminated

  • First Subject Enrolled

  • Last Subject Off Study

  • Initiated Date

  • Terminated Date

• Information that you manually for sites without subject data is rolled up in the same manner as the information for sites with subject data.

Characteristics of Trials Where Site Level Data is Not Available for a Region

Trials, for which site level information is not available for a region, display the following characteristics:

• The No Site Info field is selected for regions that do not have site level information. You do not have to select the No Subject Info field.

• CRAs (clinical research associates) can enter information in the following fields for regions that do not have site level information:

  • # Screened

  • # Re-Screened

  • # Screen Failure

  • # Enrolled

  • # Completed

  • # Early Terminated

  • First Subject Enrolled

  • Last Subject Off Study

  • Initiated Date

  • Terminated Date

  • First Site Initiated Date

  • Last Site Terminated Date

• Information that you manually for regions without site data is rolled up in the same manner as the information for regions with subject data.