Project Management for Clinical Trials
Agenda: Day Two
V. Preventing and Detecting Fraud
- Analyze case studies of fraud and misconduct
- Highlight examples of fraud and misconduct
- Detail practical approaches to recognizing, detecting and preventing fraud on your project
- Discuss objectives of FDA audits
Exercise: Dealing with Suspected Research Misconduct
Exercise: Case Study on Research Misconduct
VI. Develop a Subject Enrollment Strategy
- Establish a recruiting and enrollment strategy for investigators and for study subjects
- Learn how to project and track subject enrollment
- Discuss the use of centralized recruiting services
- Identify what to do when enrollment is not progressing as planned
VII. Develop and Lead the Project Team
- The four C's of effective team members
- Ten qualities of world class leaders
- Conducting Reviews
- Reward and recognition
- Disciplinary Action
Interactive Discussion: Specify the Necessary Qualities for an Effective Team
VIII. Conduct Effective Meetings
- Prepare and conduct successful team meetings
- Prepare for and plan investigator meetings
Interactive Discussion: Case Scenarios on Team Meetings
Interactive Discussion: Set Clear Expectations for Investigators and Respond Professionally to Unexpected Issues
IX. Meeting Review and Close
- Summarize key points from past two days of training
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.