Online Course: Clinical Trials and Drug Risk Assessment

General

Program Description

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Clinical Trials and Drug Risk Assessment

A clinical trial is an exceedingly important instrument in the assessment of treatment efficacy. With regard to clinical trials, the emphasis will be on methodological principles and on the clinical practice of therapeutic experiments. This online medical course addresses the principles of studying the effects of drug treatments on the risks of unintended effects. The accent is on proper formulation of the research problem with a view to the clinical and regulatory relevance of the study results, and on requirements for validity in non-experimental research. The course program provides a thorough medical education into the field of clinical trials, covering the principles of therapeutic research design, including a design of study, a design of data collection, a design of data analysis, including some modeling techniques in the analysis to clinical trials, and the interpretation of its results. The program also covers the principles of drug risk assessment in the context of therapeutic research.

Learning Objectives

By the end of the course, you should be able to:

Explain the basic design principles of a randomized controlled trial
Describe specialized design options for a randomized controlled trial
Apply the basic principles of data analysis of a randomized controlled trial
Describe the principles of advanced data analysis of a randomized controlled trial
Explain the principles of drug risk assessment and how to evaluate potential side effects of medication
State common practical issues in the conduct of a randomized controlled trial and suitable solutions
Design a valid randomized controlled trial for an intervention
Interpret scientific papers on randomized controlled trials

Course Deadlines

Week 0
Sunday before start date - introduce yourself

Week 1
Saturday – hand in group assignment 1
Sunday – complete Learning Unit 1

Week 2
Monday – peer feedback group assignment 1
Sunday – complete Learning Unit 2 and 3

Week 3
Tuesday – hand in group assignment 2
Thursday – peer feedback group assignment 2
Friday – hand in individual assignment
Sunday – peer feedback individual assignment
Sunday – complete Learning Unit 4 and 5

Week 4
Friday – hand in final (take-home) assignment

Examination

This Clinical Trials and Drug Risk Assessment course includes a take-home assignment. The exact deadline for this take-home assignment will be announced as soon as possible. The take-home assignment is not compulsory. However, if you want to receive the Course Certificate and the credits, it is obligatory to hand in the take-home assignment. You are allowed to redo this once.

Accreditation

As this is a university course, it is covered by academic accreditation. Upon passing the final exam, you will receive a recognized certificate from Utrecht University and the UMC Utrecht. Course is offered by Course101 As part of the following program MSc-Epidemiology-Postgraduate-Online

Last updated Nov 2019

About the School

Elevate Health offers a comprehensive range of online medical courses for researchers and healthcare professionals. Courses can be studied exclusively online, or as part of a blended plan that feature ... Read More

Elevate Health offers a comprehensive range of online medical courses for researchers and healthcare professionals. Courses can be studied exclusively online, or as part of a blended plan that features face-to-face sessions in addition to distance learning. However you choose to study, you do so at your own, wherever you are in the world -- all you need is an internet connection. Read less
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