INTRODUCTION

The goal of clinical research is to draw inferences from findings in the study about the nature of the universe around it. This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research for their clinical practice and/or achieving higher degree in health science. This is primarily accomplished by instructing students in the creation of a research protocol that is intended to address a relevant research question in their specific area of interest.

The goals for this course are for participants to:

  • acquire skills for designing and interpreting clinical research;
  • produce a complete clinical research protocol, including background, sampling, measurements, and data analysis;¬†and
  • help others in the class to develop these skills and protocols.

 LEARNING OBJECTIVES

At the end of the course the student should be able to:

  • Formulate clinical research questions which can be answered by the researcher
  • Design clinical research project to answer questions proposed
  • Describe an overview of basic biostatistical and epidemiologic methods involved in conducting clinical research
  • Prepare sampling method and sample size estimation according to study design and statistical analysis selected/planned
  • Formulate statistical techniques to answer study proposed
  • Describe the principle involved in the ethical, legal, and regulatory issues in clinical human subject research, including the role of Institutional Review Boards (IRBs).
  • Demonstrate on how to write a protocol of clinical research for dissertation or thesis

PREREQUISITES

  1. Possession of at least an undergraduate degree or enrollment in the Post Graduate Program at Faculty of Health Science, Public Health and Nutrition, Universitas Gadjah Mada, Yogyakarta.
  2. Submit an idea for a research question in clinical research that has been discussed with an experienced investigator or the thesis or Dissertation Advisor (Template can be downloaded from: http://gamel.fk.ugm.ac.id/course/view.php?id=40360 and http://www.chnrl.org). Please submit this form during your registration or email it to adhi_44@yahoo.com). Student who did not submit this form will not be enrolled in the class. We do not expect you to submit final protocol rather than draft for maximum 5 pages (excluding references).
  3. Proficiency with word processing software, biomedical literature searching with PubMed, Science Direct, Scopus, Wiley online library and reference management software (i.e.: Endnote)
  4. Students who have not had experiences for word processing software, biomedical literature searching, and reference management software will be given a special training by Staffs of Center for Reproductive Health a week before the course date. Please register for this special training to email address above.

Course Coordinator: 

Prof. dr. Siswanto Agus Wilopo, SU, M.Sc., Sc.D