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Workshop 3

Workshop 3. Trials in Practice: Project Management. Elements of Project Management. Manage: Organisations (able to provide relevant support) People (appropriate for task) Processes (robust and reliable) always customised to the trial. Make a Plan. Assess trial risk: plan accordingly

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Workshop 3

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  1. Workshop 3 Trials in Practice: Project Management

  2. Elements of Project Management • Manage: • Organisations (able to provide relevant support) • People (appropriate for task) • Processes (robust and reliable) • always customised to the trial

  3. Make a Plan • Assess trial risk: plan accordingly • Get expert advice: regulations, ethics • Make realistic costings and timelines • Plan achievable recruitment strategies • Plan focused trial promotion • Develop flexible data handling systems

  4. But for now…… What happens if the plan fails?

  5. Scenario One • You are dealing with a centre of your network delayed in sending case report forms or queries. • What do you do?

  6. You are managing a large trial which will last for 5 years in several low and middle income countries (LMIC) where an uncertain social and financial situation is “endemic”. How to prevent this situation? How do you deal with unexpected increase in salaries, taxes or rental expenses? Scenario Two

  7. Scenario Three • Consent forms are frequently complex, long and not well accepted by research personnel • During your trial monitoring you realize that the informed consent form is not signed by all participants. • How do you prevent this situation? • How do you deal with it?

  8. You are the trial manager of a clinical trial that uses the method of numbered boxes for the random allocation of the interventions. You are advised by the hospital that a new patient needs to be included but there are no intervention materials. How to prevent this particular situation? Scenario Four

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