Course Logistics and Content

All courses will be held beginning at 5:30 p.m. at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Md.  For longer classes, a small sandwich snack will be provided. Lectures, case studies, and small group discussions with faculty will clarify the subject matter. Readings and homework assignments will be used to assure adequate preparation.  Peer critiques of student projects will be used throughout the sequence.  At the end of each course, students will be given a post-test in the form of a take-home exam and/or final project or paper.

Required Courses:
390.676 Design of Clinical Studies (3 credits)**

Mondays, 10/24/11-12/19/11, 5:30-8:30 pm

• Examine scientific methods applied in a clinical setting
• Frame a scientific question in quantitative terms
• Choose a clinical study design
• Collect and manage data
• Formulate statistical inferences about research questions
• Write a brief protocol for a clinical study
• Critically evaluate strengths and weaknesses in study design

390.672 Quantitative Analysis of Clinical Data** (3 credits)

Mondays, 1/23/12-3/12/12, 5:30-8:30 pm

• Explore the statistical approach to scientific inference
• Produce effective graphical and tabular displays of research information
• Examine aspects of the design and analysis of data from observational and experimental clinical studies
• Read, understand, and critically discuss quantitative methods used in the scientific literature on clinical investigation
• Analyze and interpret basic quantitative data

**Courses are open to SOCI certificate students ONLY

Students must also complete two of the following:
390.677 Database Design and Implementation in Clinical Research (2 credits) *** see note under Registration

Mondays, Wednesdays and Thursdays, 8/1/11-8/11/11, 5:00-7:00 pm
Monday and Wednesday, 8/15/11-8/17/11, 5:00-7:00 pm

•   Acquire basic concepts of relational database design for clinical and basic research including development of data collection forms, design of a relational database, data quality control, and importing and exporting collected data across different platform
•   Construct a database environment for efficient storage and access of data
•   Perform queries for data quality control and exportation to statistical packages for analysis

390.673 Ethical and Regulatory Issues in Clinical Research (3 credits)

Mondays, 8/29/11-10/17/11, 5:30-8:30 pm

•   Critically examine  ethical issues central to clinical research
•   Review the regulations of clinical investigation
•   Incorporate modern ethical standards and regulatory requirements into the design of a clinical investigation
•   Construct good clinical practices for clinical trials
•   Understand the ethical underpinnings and regulatory requirements for human subjects research in the US and abroad

390.675 Outcomes and Effectiveness Research (3 credits)

Tuesdays, 3/27/12-5/15/12, 5:30-8:30 pm

• Analyze experimental and observational designs, including understanding of alternative approaches to addressing confounding in controlled observational studies, methods for evaluating the effectiveness of patient-level interventions, and methods for evaluating the effectiveness of providers and provider-level interventions
• Examine a wide range of outcomes including time to event outcomes, longitudinal outcomes, cost of care, and patient-reported outcomes
• Write a preliminary design for an outcomes or effectiveness study
• Critically evaluate outcomes and effectiveness research

For additional course information visit http://commprojects.jhsph.edu/courses/