Who Should Attend?

Clinical Research Nurses and Study Coordinators with at least one year of coordinator experience who have attended a basic training course in clinical trial coordination and/or who have equivalent knowledge of FDA regulations and GCPs

Day 1 AM

Creating and Using Financial Reports

• Planning financial status reports
• Planning financial projection reports
• Sample single-and multi-study financial reports
• Collecting the data

Analyzing a Protocol, Financially

• Defining team member roles
• Standardizing protocol analysis
• Analyzing the protocol
• Identifying each study event
• Pricing each study event

Day 1 PM

Drafting the Subject Budget

• The combination budget process
• Drafting the subject budget
• Line item costs and charges
• Revising the subject budget

Completing the Study Budget

• Drafting the study budget
• Study budget - Line items
• Finalizing the study budget
• Securing final approval
• Special budget requirements for federally funded research and CRO's

Day 2 AM

Negotiating the Contract

• Preparing to negotiate the contract
• Determining the contracts vocabulary
• Analyzing the payment schedule
• Negotiating the contract terms

Tracking Study Activity

• Focusing tracking activity
• Tracking subject activity for each study
• Creating a subject database
• Completing subject activity reports

Securing Sponsor Payments

• Assembling billing information
• Billing the sponsor
• Verifying the Payment
• Completing income reports

Day 2 PM

Paying Study Expenses Accurately

• Assembling expense information
• Verifying expenses and paying vendors
• Paying research subjects/vendors
• Completing expense reports

Selecting computer tools

• Hardware
• Office software
• Clinical trials software

Learning to Do Better

• Troubleshooting
• Enjoying an audit
• Analyzing a successful clinical trial