Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits >

About Rolling Up Information for Subject Enrollment

One of the key capabilities of Siebel Clinical is supporting clinical organizations to better manage subject enrollment for their trials in real-time. This tracking is implemented though rolling up subject information 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, it is often the case that this data is not available to the clinical organization, which presents significant business challenges.

For example, if trials are out sourced to CROs (clinical research organizations), then it is not always possible for the clinical organization to receive subject level information. The enhanced subject rollup functionality allows accurate subject enrollment data to be available at the region and protocol level, even when subject level information is not available for each site, or when site level information is not available for each 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 to a site, region, or protocol, the First Subject Enrolled Date 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 Last Off Study Date for that site, region or protocol is automatically populated.

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 available.
• 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 manually entered 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 available. 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 manually entered for regions without site data is rolled up in the same manner as the information for regions with subject data.