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Project Management for Clinical Trials

Develop and Manage Complex Project Plans

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

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

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