Principles of clinical research course

Course description

This online course addresses the importance of research and evidence-based medicine (EBM), the relevant ethical considerations and guidelines for Good Clinical Practice (GCP). Participants will learn how to formulate a clinical research question as well as practicing skills related to critical literature review, working with a statistician, and navigating the AO Program for Education and Excellence in Research (AO PEER)–all with the aim of making their research project a success.

Participants will be guided through eight consecutive modules in a self-directed manner. There will be the opportunity to exchange thoughts and challenges in an interactive forum.

Participants of this self-directed online course will be encouraged to involve a mentor (i.e. a person from their network/university/institution etc. for support and advice throughout this course and beyond). The mentor is important for several tasks during this course. There are no specific prerequisites for a person to act as a mentor, but we recommend the following:

• Several years of experience in clinical research and publishing
• Several years of experience in mentoring
   

Target participants

This course is aimed at individuals who want to learn or improve the skills in conducting clinical research and publishing results and also at those with a general interest in research and documentation of clinical cases.
 

Goal of the course

The goal of this course is to introduce the principles of clinical research, including skills and knowledge on why and how to do research, how to build a good research environment, and where to find additional resources, tools, and reference packages to support a research project.
 

Learning objectives

At the end of this course, participants should be able to:

• Explain the importance of doing research and the link to evidence-based medicine
• Apply the basic principles of literature search and critical appraisal
• Follow GCP guidelines and adhere to ethical requirements, eg, informed consent
• Identify a clinical problem, formulate a clinical research question, and select the study design
• Collaborate with a statistician to perform sample size calculation and basic statistical analyses
• Describe the principles of medical writing
• Utilize available research environment, resources, and tools
   

Duration

• The course is structured in eight modules
• Each module comprises a sequence of learning activities, of altogether 2–5 hours duration to be completed at participants' own pace
• Total course learning time: 20 hours
• Participants have a time frame of five weeks to complete one module
• Access to the course material: one year