Existing Data Management Labor Updates

ClearTrial 6.0 adjusts existing 5.9 resources and resource level-of-effort algorithms in the 6.0 Cost Model.

The 5.9 and 6.0 Major Task names have not been changed for the following Major Tasks and Tasks.

5.9/6.0 Major Task Name	5.9 /6.0 Task Name
Unique CRF Page Developed	Write and approve instructions for CRF Page (or EDC equivalent)
Database Designed	Create database design specifications
Database Designed	Build the study database
Data Entry Screen Developed	Design Data Entry screen
Data Entry Screen Developed	Conduct UAT and validate EDC system
Protocol Amendment	Update design of existing Data Entry screens
Protocol Amendment	Review new/modified CRF fields for protocol amendment
Protocol Amendment	Write and approve instructions for CRF page
Protocol Amendment	Update database edit specifications due to protocol amendment
SAE Processed	SAE Reconciliation
Sponsor Oversight	Oversee – Unique CRF Page Developed
Sponsor Oversight	Oversee – Database Designed
Sponsor Oversight	Oversee – Data Entry Screen Developed
Sponsor Oversight	Oversee – Data Management
Sponsor Oversight	Oversee – SAE Processed