PTI - international

Agenda: Day One

• Examine the drug development process
• Define the phases in conducting clinical trials
• Identify the types of clinical trial designs
• Understand the drug review and approval process

II. Clinical Project Team Responsibilities

• List the key responsibilities of a clinical project manager
• Define specific responsibilities for each team member during each stage of a clinical trial
• Create a clinical trial timeline
• Perform a risk assessment exercise

Exercise: Create a List of Management Tasks and Delegate Responsibilities

Exercise: Risk Assessment Activity

III. Study Start-Up 

• The timeline of events required to start a clinical trial
• How to put together a clinical trial team
• How to negotiate clinical trial contracts
• How to create a Project Plan

Exercise: Determine Necessary Resources of Your Clinical Study

Interactive Discussion: Brainstorm Effective Methods for Site Selection 

IV. Financial Management of a Clinical Trial

• Negotiate and manage investigator grants/contracts
• Develop a project budget
• Develop a tracking system for investigator budgets and project budgets
• Establish a scope change management plan

Exercise: Create a Timeline for Your Clinical Trial

Interactive Discussion: Address the Consequences of Contract Modifications