A four-day introductory course on the principles and methods of clinical investigation. Introduction to Clinical Investigation

Course Details and Preparation

Dates and Location

This course is offered once a year. The next session will take place:

  • October 3-6, 2016
  • Sheraton Commander Hotel, Cambridge, MA

Preliminary Outline

Day 1
Lectures: Introduction to Clinical/Translational Research, Regulatory Considerations (Drugs, Devices, Biologics), Principles of Biostatistics and Study Design
Day 2
Lectures: Ethics of Human Investigation and the Institutional Review Board (IRB)
Workshops: T2 Research, Cost and Comparative Effectiveness, IRB
Day 3
Lectures: Qualitative Methods, Mixed Methods Research, Funding Sources, Writing a Scientific Paper
Workshops: Qualitative Research Methodologies, Case Study: Childhood Obesity
Day 4
Interactive Presentations: Communication arts, including audience interaction with the Bok Players, delivering oral scientific presentations
Informational Lecture: Navigating the research resources in the extended Harvard community and next steps for a career in clinical investigation.

Course Preparation

To maximize your experience in this intensive course, additional preparation beyond in-class time is required. In submitting this application, you agree that you are able and willing to make the time and do your part to contribute to the success of the course.

Preparation for the four-day course will include readings for each didactic lecture, as well as in-class group reports on the workshops scheduled throughout the week. Your first priority is to spend time preparing for the workshops. This prep time will include participating in an online discussion group and sharing ideas generated in the course. As the course days will be busy, you should finish most of the assignments before the start of the course. Readings and workshop materials, along with online discussion group information, will be electronically posted beforehand, giving you ample time to prepare.

Course Completion

Upon completion, participants will receive 1) a certificate of course participation, and 2) CME credit (if applicable).

The Harvard Catalyst Education Program is accredited by the Massachusetts Medical Society to provide continuing medical education for physicians.

Watch Videos

See videos of previous ICI courses in the Education Video Library.

Read More

Read a feature story in Focus about the ICI course and how it fits into Harvard Catalyst's education & training opportunities.