Introduction to Clinical Research
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This one-day course provides a general overview of the clinical research process, regulations, terminology, acronyms as well as roles and responsibilities within the clinical research setting. The following topics will be covered:
• Developing a drug in the pharmaceutical industry – from the idea to the product you buy in the pharmacy – and the contributions of clinical research
• What is a clinical study – the four phases of clinical development
• Who are the key players and what are their roles in the process
• The language and abbreviations the clinical research team are using every day
• What are the rules, guidelines and laws that need to be followed and why are they so important
• How is a clinical study performed – from preparation over conduct to termination of a study
• A key to a successful study: the master study file. What documents are essential and how are they handled, filed and archived?
• What is the job description and what is the role of a clinical research assistant?