Course Logistics and Content
Training program candidates will complete two required and at least two elective courses.
For the achievement award, SOCI participants must complete two required courses and at least two electives. The courses are officially taken as non-credit and regular attendance and completion of all coursework is required. The Training program is not open to Johns Hopkins University degree students. However, with the course director’s approval, JHU degree students can take individual courses as electives for-credit outside of the training program. Participants may apply and begin the program at any point during the academic year.
Also, with appropriate backgrounds as determined by the course director, single courses can be taken without enrolling in the training program.
Courses can be taken on-site, online, or a combination of the two. All on-site courses will be held beginning at 5:30 p.m. at the Johns Hopkins Bloomberg School of Public Health in Baltimore. The Johns Hopkins Bloomberg School of Public Health’s Academic Year consists of four 8-week terms. For term dates, please view the current Academic Year Calendar.
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 an exam and/or final project or paper.
Required Courses
Introduction to Online Learning (non-credit, free, mandatory for new online students)
Students who are taking an online course for the first time must register for Introduction to Online Learning (IOL). This course is a free mandatory course that will prepare a learner, and their computer, for taking an online course through the Johns Hopkins Bloomberg School of Public Health. Please view the IOL schedule and do not wait until the last minute to register for this course.
Design of Clinical Studies (3 credits)**
- 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)**
- 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
** On site courses are open to SOCI Training Program students ONLY
Electives
Students must also complete two of the following:
390.677 Database Design and Implementation in Clinical Research
- 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)
- 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)
- 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
390.678 Quality Improvement and Knowledge Translation (3 credits)
- Summarize the importance of and point of view regarding quality improvement/knowledge translation for policymakers, providers, and the public
- Describe one conceptual framework for quality improvement/knowledge translation research
- Identify and assess barriers and facilitators for quality improvement/knowledge translation interventions
- Discuss issues regarding the selection, tailoring, and implementation of quality improvement/knowledge translation interventions
- Apply the concepts and tools to a quality improvement/knowledge translation project of the student’s choosing
312.693 Introduction to Comparative Effectiveness and Outcomes Research (3 credits)
- Introduces students to the motivation and methods of comparative effectiveness research
- Reviews the problems faced by decision makers across the US health care system, and the priority topics for investigation
- Explains the role of stakeholders, including payors, manufacturers, health care organizations, professional groups, providers, and patients
- Explains study designs and methods used in effectiveness research, focusing in particular on observational studies
On-Site Course Schedule
Summer
(390.677.01) Database Design and Implementation
(Wednesday and Thursday, 8/14/13-8/15/13, 5:00-7:00 pm)
(Mondays, Wednesdays and Thursdays, 8/19/13-8/29/13, 5:00-7:00 pm)
This course is not available online
First Term
(390.673.01) Ethical and Regulatory Issues in Clinical Research
(Mondays, 5:30-8:30 pm)
Second Term
(390.676.01) Design of Clinical Studies
(Mondays, 5:30-8:30 pm)
Third Term
(390.672.01) Quantitative Analysis of Clinical Data
(Mondays, 5:30-8:30 pm)
Fourth Term
(390.678.01) Quality Improvement and Knowledge Translation
(Mondays, 5:30-8:30 pm)
(390.675.01) Outcomes and Effectiveness Research
(Tuesdays, 5:30-8:30 pm)
The Johns Hopkins Bloomberg School of Public Health’s Academic Year consists of four 8-week terms. For term dates, please view the current Academic Year Calendar.
Online Course Schedule
First Term
(312.693.81) Introduction to Comparative Effectiveness and Outcomes Research
Second Term
(390.673.81) Ethical and Regulatory Issues in Clinical Research
Third Term
(390.676.81) Design of Clinical Studies
Fourth Term
(390.672.81) Quantitative Analysis of Clinical Data
The Johns Hopkins Bloomberg School of Public Health’s Academic Year consists of four 8-week terms. For term dates, please view the current Academic Year Calendar.
Course Requirements
SOCI Training Program candidates must satisfactorily complete two required courses and two elective courses.
Participants may apply and begin the program at any point during the academic year.
For each course 6 of 8 classes must be attended, and all online discussions, homework and class assignments must be completed, including any take-home exams or projects.
The training program must be completed within three years of entry.
An achievement award, signed by the dean of the Bloomberg School and the program director, will be presented to those who successfully complete four or more courses. This award may be acceptable as evidence of advanced training in clinical investigation for purposes of employment or advancement.