Twelve tips for conducting a postgraduate course on study design and study protocol writing for the medical profession

Background: It is desirable to use a methodological approach of the highest scientific quality when planning and conducting valid research. However, several studies have shown that the biostatistical and epidemiological knowledge of academically active health care professionals is far below the desired level. Aim: To outline an approach to conducting a postgraduate course in clinical study design and study protocol writing. Method: We offer 12 tips based on critical reflection of our experience of conducting and continuously improving a course in study design repeatedly over several years, combined with evidence from the literature on pedagogical approaches. Result: The tips are organized in chronological order so that a course director will be able to develop a similar course. Conclusion: Combining the results of our critical reflection with evidence from the literature has allowed us to develop a successful approach to running courses in study design and study protocol writing. We hope that our extensive experience in conducting this course, as reflected by the 12 tips, will support and inspire others planning similar courses.