This is supplemented with SOME face-to-face sessions. If the course has an exam component, This will be administered on-campus. To be confirmed. This site uses cookies to offer you a better browsing experience. Synopsis Topics Learning Outcome. Clinical Trials BME Describe what is a research protocol. Discuss the key elements of a research protocol. Explain the different types of trial designs, such as double-blinded, single-blinded and open-label trials. Duration: 26min 03sec Documents: Click here to download the handout.
Topic 4: Site Start-up Activities. Define study start-up activity. Explain the importance of having efficient clinical trial start-up activities.
Discuss the activities involved during the clinical trial start-up phase, such as mapping the processes, clinical trial agreement, budget, and logistic preparation. Duration: 28min 11sec Documents: Click here to download the handout. Discuss the types of IRB review — exempted, expedited and full board review. Explain the different types of IRB application review outcome.
Duration: 27min 05sec Documents: Click here to download the handout. Describe the different types of recruitment strategies. Identify the differences between pre-screening and screening. Discuss the activities involved during pre-screening and screening.
Duration: 11min 57sec Documents: Click here to download the handout. Topic 7: Study Follow-Up and Discontinuation. Learn how to schedule and track study visit. Understand how abnormal finding in clinical trial are handled.
Describe the importance of trial subject retention and compliance. Describe the principles for trial subject compensation. Duration: 16min 16sec Documents: Click here to download the handout. Describe the IRB safety reporting process for adverse event and serious adverse event.
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