Work Breakdown Structure Updates

Oracle ClearTrial 5.5 includes new and updated ClearTrial-defined Major Tasks, Tasks, and resources for late-stage studies. Please refer to the following tables for detailed updates.

Table 5-2 New Major Tasks and Tasks in 5.5

New Major Tasks	Associated Tasks
Medical Data Listing Review	Review medical data listings
Subject Monitored	Review clinical data and CRFs
Subject Monitored	Review alert lab and diagnostic test results
Cohort Escalation Review	Review data to determine dose escalation

Table 5-3 Existing Labor Updates in 5.5

Existing Major Tasks	Associated Tasks
Study Setup	Safety system setup
Study Setup	Develop SAE management plan
Study Setup	Prepare therapeutic training materials
Project Management Week after FSI	Post-FSI — Manage safety processes
SAE Processed	Process SAE
SAE Processed	Enter data and perform quality review
SAE Processed	SAE reconciliation
Expedited Safety Report Completed	Produce expedited safety report
Expedited Safety Report Completed	Expedite safety reports to central ethics committees
Expedited Safety Report Completed	Expedite safety reports to local ethics committees
Expedited Safety Report Completed	Expedite safety reports to sites
Sponsor Oversight	Oversee — Cohort escalation review
Sponsor Oversight	Oversee — Medical data listing review
Sponsor Oversight	Oversee — Subject monitored

Table 5-4 New Resources Available in 5.5

Resource Name	Resource Code
Medical Associate	DS02
Safety Specialist	PV01
Safety Coordinator	PV02
Safety Database Administrator	PV03

Table 5-5 New Resource Effort in 5.5

Tasks	Resources
Develop scope of work, timeline, work assignment	Safety Specialist
Review protocol	Medical Monitor
Coordinate DSMB setup activity	Medical Monitor
Coordinate DSMB setup activity	Medical Associate
Internal Team Meeting	Medical Associate
Medical monitoring	Medical Monitor
Medical monitoring	Medical Associate
Expedite safety reports to regulatory agencies	Regulatory Submissions Specialist
Expedite safety reports to regulatory agencies	Safety Specialist
Write the SAE narrative	Safety Specialist
Write the SAE narrative	Medical Monitor
Conduct medical review of the SAE	Medical Monitor
Design study documents	Safety Specialist
Design study documents	Safety Coordinator
Oversee — Study Setup	Clinical Research Associate
Oversee — Study Setup	Safety Specialist
Oversee — Project Management Week after FSI	Medical Monitor
Oversee — Project Management Week after FSI	Medical Associate
Oversee — Project Management Week after FSI	Safety Coordinator
Oversee — SAE Processed	Safety Specialist
Oversee — SAE Processed	Safety Coordinator
Oversee — Expedited Safety Report Completed	Safety Specialist
Oversee — Expedited Safety Report Completed	Safety Coordinator.

Table 5-6 Resource Effort Removed in 5.5

Tasks	Removed Resources
Produce and distribute subject information video	Medical Monitor
Review CRF (or EDC equivalent)	Medical Monitor
Conduct medical review of the SAE	Senior Vice President Clinical
Conduct medical review of the SAE	Project Manager
Collect the SAE data from the investigator	Medical Monitor
Write the SAE Narrative	Senior Director, Clinical/Therapeutic
Expedite safety reports to regulatory agencies	Director, Regulatory Affairs
Oversee — SAE Processed	Clinical Research Associate
Oversee — SAE Processed	Project Admin Assistant