Gestión de Proyectos para Ensayos Clínicos

The Project

• Project definition
• Project/program/portfolio

The Project Manager

• Roles and responsibilities in clinical trials
• The ‘ideal’ Project Manager
  • Factors for success
• Personal pre-requisites
• Knowledge, skills and competence

The Project Team

• Organizing a team
• Decision making levels and powers of authority
• Delegation and distribution of tasks
• Responsibilities and levels of decision making
• ‘Good communication practice’
  • Channels of communication and information flow in teams
• Meeting culture
• Conflict management
• The goal: a successful and effective project team

Project Planning

• Project life-cycle
• The magic triangle: variables under control
• Defining the scope and limits of a project
• Project planning
  • Clinical Trial Operations Plan
  • Project Management Plan
• Establishing a timeline, setting milestones
• Efficient project management tools
  • Planning with MS Project and Excel
  • Simulations
• Recruitment planning and strategies
  • Site and investigator selection
• Risk management: The contingency plan
  • Contents
  • Potentials risk areas/ risk categories

Preparation and Conduct of a Clinical Trial

• Developing the protocol
• Contact with Ethics Committees and Responsible Authorities
• Metrics and analyses as aids for project assessment
  • Allocation and sources of metrics
  • Validating measuring instruments
  • Interpreting data
• Analyzing problems and assessing their severity
  • Setting priorities
  • Decision making tools
  • Risk assessment and quality management
• Reporting
  • Static, analytical or interactive reporting?
  • Software models and their practicability
• Documentation and archiving

Capacity and Budget Planning and Control

• Optimum planning of resources
  • Study complexity
  • Utilization and experience of CRA
• Budget control
  • Levels of budget planning
  • Calculating the budget
  • Typical problems
• Capacity and budget planning in international projects
• Budget and manpower planning
  • Calculating study costs
  • Monitoring Plan
  • Acceptable tolerance limits in the event of deviation