New Plan Summary Group

Oracle ClearTrial 5.5 includes a new summary group for Safety and Medical Management, displayed primarily on the Plan Summary tab and associated reports. This new summary group includes the following direct labor fees:

• Post-FSI - Manage safety processes

• Process SAE

• Enter data and perform quality review

• Conduct medical review of the SAE

• SAE reconciliation

• Produce expedited safety report

• Expedite safety reports to regulatory agencies

• Expedite safety reports to central ethics committees

• Expedite safety reports to local ethics committees

• Expedite safety reports to sites

• Review medical data listings

• Review clinical data and CRFs

• Review alert lab and diagnostic test results

• Review data to determine dose escalation

• Medical monitoring