EU CTR Impact to Labor Fees

ClearTrial 6.0 adds new logic that includes/excludes effort dynamically based on the locations that exist in a plan/template in the 6.0 Cost Model.

If a location in EU CTR scope exists in a plan/template, then new ClearTrial-defined EU CTR labor activities by regulatory resources are included while excluding “Obtain country level regulatory approval” task effort for each applicable location in the budget, thus leveraging the 6.0 Cost Model. Additionally, if a protocol amendment is defined in that plan/template, then new effort for “Modify EU CTR application for protocol amendment” will be included in the budget, while “Obtain country level approval for Protocol Amendment” task effort will be excluded for each applicable location.

Otherwise, when a location not in scope for EU CTR exists in a plan/template, then the “Obtain country level regulatory approval” task effort is included in the budget while excluding the new EU CTR activities. Additionally, if a protocol amendment is defined in that plan/template, then effort for the “Obtain country level approval for Protocol Amendment” will be included in the budget while the new “Modify EU CTR application for protocol amendment” task effort will be excluded.

New EU CTR-specific Labor

6.0 Major Task Name	6.0 Task Name
EU CTR Approval – Part I	Obtain EU CTR approval – Part I
EU CTR Approval – Part II	Obtain EU CTR approval – Part II
Protocol Amendment per Location	Modify EU CTR application for protocol amendment