Study Set Up course
About the training
Conducting clinical research can be a daunting task at the best of times. This is particularly true if you are new to the field. AO Clinical Investigation and Documentation has been conducting worldwide clinical research for decades and has gained extensive experience in running various types of studies in different disciplines. AOCID has assembled the most important theoretical and practical information needed to begin a clinical investigation into this one short course.
The Study Set Up course is an interactive introductory series of lectures and workshops on how to plan clinical research. Good study planning is essential, not least because studies may run for years. Clinical trials need to be thoroughly thought through in detail to avoid any unnecessary delays or missing data down the line.
This course is available in several different formats. It was given as a full day event under the title "Study Set Up" course in China and India in 2014. A four hour model branded "How to Plan a Clinical Study" was given in February 2015.
This is an ideal course for interested surgeons to be introduced to the processes behind planning and beginning a clinical investigation.
Participants on this course will learn the main theories and principles which underpin good study planning and set up. Three distinct blocks bring clinical study considerations, study conduct tools, and legal regulations and guidelines into focus.
The course syllabus is as follows:
1. Research question and study design
Short introduction to evidence based medicine
Importance of good methodology, measures to avoid bias
Different study designs
The PICOT model and PICOT workshop
Sample size calculation
2. Clinical Investigation Plan (CIP)
CIP development, content and structure
3. Introduction to Good Clinical Practice
Guidelines ICH E6 / ISO 14155
How to get started: good planning practice