Students are provided with weekly readings from textbooks and from the original literature. Each session consists of a one-hour didactic lecture providing an overview of the subject matter of the particular week's topic followed by a small group tutorial during which time students will develop their protocols with the assistance of tutors. Students are expected to develop their own controlled clinical trial proposal throughout the term. These proposals will serve as the focal points for the discussions during the tutorial sessions. At the completion of the course students will have completed a fully developed proposal which will be presented at an oral presentation and submitted as a final protocol.

Objectives: this introductory course is designed to provide the student with necessary background and tools for the design and conduct of a 2-arm parallel group controlled clinical trials. It is geared for the individual who wishes to pursue a career as an independent investigator and clinical trialist but will be of interest in others who wish to be involved in clinical trial in other capacities. Students should prepare for the course by developing a research question that can be addressed using randomized controlled trial design and starting their literature review. Students are encouraged to design a 2-arm parallel group superiority trial; students should contact the course instructors if considering a different design. As this is an introductory course, students seeking advanced design may consider HAD5313H Advanced Design and Analysis Issues in Clinical Trials after its completion. In order to assist the coordinators in assigning small group tutorials, please inform the Tutorial Assistant of your clinical specialty.