At the end of this course you will know:
The principles of project management
• Defining the scope of the project
• Timeline management and tracking the project
• Maintaining the quality of the deliverable
• Budgeting for the clinical investigation

Where to set up a clinical investigation rapidly
Which countries are the most appropriate for your clinical investigation
How to manage the clinical investigation to ensure a high-quality report
How to confidently predict the study end-date

Who should attend?
Clinical managers responsible for the conduct of multi-center clinical investigations in Europe. This course will benefit new and experienced project managers.

Program:
What is project management?
How does this theory apply to clinical investigations?
Project planning and project start-up
Defining the scope of a clinical investigation
• Which countries and why?
• How many patients and why?
• Which investigators and why?
• How to report the study
Developing the budget for a clinical investigation
• Investigator fees, Internal costs, External costs,
Sample budget


Developing the timeline for a clinical investigation
• Gantt charts, start-up
• Ethics committees
• Competent authorities
• Site initiation
• Sample Gantt chart
• Tracking study progress
• Critical path analyses
Case study workshop
Defining the quality of the clinical investigation deliverable
• Evaluable patients
• Query rates Communication planning
• To investigators
• To internal team
• To external team
Managing the ongoing study
Timeline review and management
• Progress reporting and contingency planning
Budget review and management
• Budget analyses, actual versus projected
Quality review and management
• Query rates
Communication with the project team
• Status reports
• Meetings
• Problem solving
Completing the study
Final study deliverable
Project close-out
• Budget
• Administrative
• Team
Lessons learned


For information on booking D-TARGET training courses, please contact us.