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Science of Clinical Investigation Training Program

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 (JHU) 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-campus, on-line, or a combination of the two.  All on-campus courses will be held beginning at 5:30 p.m. at the BPSH in Baltimore.  The BSPH 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 BSPH.  Please view the IOL schedule and do not wait until the last minute to register for this course. 

390.676 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
  • Prerequisite Course:  390.676 Design of Clinical Studies (3 credits)

** These courses are open to SOCI Training Program students ONLY


Students must also complete (at least) two of the following:

390.677 Database Design and Implementation in Clinical Research (2 credits) 

  • Development of data collection forms
  • Building databases for both "classic" and "longitudinal" projects using REDcap
  • Data quality control 
  • Data security 

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

  • Observe the ethical underpinnings of human subjects research
  • Identify good clinical practices for clinical trials, including the use of standard operating procedures
  • Identify the requirements and procedures for IRB approval of human subject research, including recent HIPAA regulations
  • Integrate modern ethical standards and regulatory requirements into design of a clinical investigation

390.675 Outcomes and Effectiveness Research (3 credits)

  • Describe a wide variety of innovative approaches to outcomes and effectiveness investigation
  • Craft a preliminary design for an outcomes or effectiveness study
  • Develop skills needed to critically evaluate the strengths and weaknesses of outcomes and effectiveness research
  • Identify the implications of outcomes and effectiveness studies for end-users

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

On-Campus Course Schedule

Summer Term  

(390.677.71) Database Design - Dates for 2022-23 are:

July 18, 19, 20, 21, and July 25, 26, 27, 28 
(Mondays - Thursdays, 5:00-7:00 pm - TAUGHT VIA ZOOM real time)

First Term  August 29 - October 24, 2022

(390.673.71)  Ethical and Regulatory Issues in Clinical Research 
(Mondays, 5:30-7:30 pm - TAUGHT VIA ZOOM real time) Due to the Labor Day Holiday, class will be held on Tuesday 9/6 rather than Monday 9/5

Second Term   October 26 – December 23, 2022

(390.676.01)  Design of Clinical Studies
(Mondays, 5:30-7:30 pm - TAUGHT HYBRID - combination of in-person and virtual)

Third Term  January 23– March 17, 2023

(390.672.71)  Quantitative Analysis of Clinical Data
(Mondays, 5:30-8:30 pm - TAUGHT VIA ZOOM real time)

Fourth Term   March 27 – May 19, 2023

(390.675.71)  Outcomes and Effectiveness Research
(Mondays, 5:30-7:30 pm - TAUGHT VIA ZOOM real time)

(390.678.71)  Quality Improvement and Knowledge Translation
(Mondays, 5:30-8:30 pm - TAUGHT VIA ZOOM real time)

On-line Course Schedule

First Term   August 29 - October 24, 2022

(390.678.81)  Quality Improvement and Knowledge Translation

Second Term   October 26 – December 23, 2022

(390.673.81)  Ethical and Regulatory Issues in Clinical Research

Third Term   January 23– March 17, 2023

(390.676.81)  Design of Clinical Studies

Fourth Term   March 27 – May 19, 2023

(390.672.81)  Quantitative Analysis of Clinical Data

The BSPH Academic Year consists of four 8-week terms.  

Course Requirements

SOCI Training Program candidates must satisfactorily complete at least four courses - two required courses and at least 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 BSPH and the SOCI 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.