Clinical Studies: Planning and Implementation of Clinical Research

On successful completion of the course, the candidate:

Knowledge:

• Has advanced knowledge of how to identify the society’s needs for clinical studies and health research priorities and how to include clinical challenges and relevant issues
• Has advanced knowledge of how to evaluate, design and implement complex clinical studies, including interventions and use of digital tools
• Has advanced knowledge of research ethics
• Has advanced knowledge of implementation of user involvement throughout the study
• Has advanced knowledge of how to publish (disseminate) study results

Skills:

• Can critically evaluate existing theory, previous studies and clinical practice to identify knowledge gap in health care and practice
• Can outline hypothesizes, aims and outcomes for clinical studies
• Can use relevant research methods to address the research question in clinical studies
• Can write a research protocol for clinical studies
• Can make ethical considerations, include user participation and national and international cooperation partners, use laws and regulations and how to register clinical studies and biobanks
• Have skills to monitor clinical studies, recruiting participants, and plan a good study infrastructure and financing
• Can distinguish variability, reliability and statistical and clinical relevance of a clinical study
• Can critically evaluate, interpret, and disseminate empirical evidence of clinical study (Vancouver rules)

General competence:

• Is in the forefront when it comes to identifying needs for, plan, implement and evaluate the effect of interventions in clinical studies and clinical studies in general in accordance with updated ethics, laws and regulations
• Can communicate relevant knowledge through scientific and popular scientific channels

• Various clinical intervention studies and instruments for measurement
• Drafting a research protocol for a clinical intervention study including ethical considerations, user involvement and sample size calculations
• Methodology, principles and practical implementation and application of clinical intervention studies
• Results assessment and dissemination