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About Subject Enrollment Information Roll-Up

One of the key capabilities of Siebel Clinical in supporting clinical organizations to better manage their trials in real-time enrollment status tracking. This is implemented though rolling-up subject information from Site to Region and then to protocol or directly from Site to Protocol. 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 it is not always possible for the clinical organization to receive subject level information. The enhanced subject roll-up functionality allows accurate subject enrollment data to be available at 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.

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

• Subject enrollment information is automatically rolled-up from Subject to Site, from Subject to Region, and from Subject to Protocol.
• 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.

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

• Sites that do not have subject-level information available may be check-marked as having No Subject Info.
• The following information may be entered by CRAs for sites that do not have subject or site level information:
  • # Subjects Screened
  • # Subjects Re-screened
  • # Subjects Screen Failure
  • # Subjects Enrolled
  • # Subjects Completed
  • # Subjects Early Terminated
  • First Subject Enrolled Date
  • Last Subject Off Study Date
  • Site Initiated Date
  • Site Terminated Date
• Information manually entered for sites without subject data is rolled-up in the same manner as that for sites with subject data.

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

• Regions that do not have subject-level information available may be check-marked as having No Site Info.
• The following information may be entered by CRAs for regions that do not have site-level information:
  • # Subjects Screened
  • # Subjects Re-screened
  • # Subjects Screen Failure
  • # Subjects Enrolled
  • # Subjects Completed
  • # Subjects Early Terminated
  • First Subject Enrolled Date
  • Last Subject Off Study Date
  • Site Initiated Date
  • Site 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 that for regions with subject data.