Welcome to the Clinical Research Track of the upgraded CASE-2.0 Research Elective. The goal of the four to eight week rotation is to prepare you to submit an IRB proposal for clinical research that is strong in terms of science, statistics, ethics, and logistics. To achieve this goal, we ask you to complete the following tasks:

1. Web courses related to human research, ethics, conflict of interest, and privacy. Upon successful completion of the web courses, you’ll obtain certificates that qualify you to conduct clinical research atJohns Hopkins. Click to check on requirements and to access the training website.

2. Web-based courses on quantitative research methods (biostatistics and epidemiology) originally developed by the Johns Hopkins Bloomberg School of Public Health (http://ocw.jhsph.edu/Topics.cfm?topic_id=33). Self-paced study and self-evaluation will be complemented by discussions with other CASE-2 residents. Limited office hours with methodologic experts will be provided for course- or research project-related questions.

3. Meet with an expert in clinical epidemiology once per week in a small group to refine your research question and study design.

To make best use of the elective time, we strongly recommend that you complete the following two tasks as soon as the elective begins, or at least attempt to complete them:

1. Identify a research mentor who will serve as Principal Investigator on your IRB proposal.

2. Draft an abstract to describe your proposed research. The abstract should be no more than one typed page (about 250 words or less), and should cover the following headings and subheadings:

• Introduction/Background/Context
• Main Hypothesis
• Methods
  • Study Design
  • Participants
  • Data Collection
  • Main Outcomes
  • Analytic Approach

3. Significance

Please e-mail your abstracts to Dr. Merlo ([email protected]) and the faculty leader before the first small group discussions.