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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.  Participants may apply and begin the program at any point during the academic year.

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)

  • Develop a research question
  • Specify a testable hypothesis
  • Select a study design understanding strengths and weaknesses
  • Prepare a data and analysis plan
  • Estimate study power and sample size
  • Prepare and present a research protocol

390.672 Quantitative Analysis of Clinical Data (3 credits)

  • Read, understand and critically discuss quantitative methods used in the scientific literature on clinical investigation
  • Produce effective graphical and tabular displays of data and interpret results
  • Understand fundamentals of statistical inference
  • Be able to effectively communicate with a biostatistician as part of team science
  • Prerequisite Course:  390.676 Design of Clinical Studies (3 credits)

Elective Courses 

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

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

  • Construct a database environment for efficient storage and access of data
  • Perform queries for data quality control and exportation to statistical packages for analysis
  • Describe the relational database environment

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

  • Reflect on the fundamental ethical principles that govern biomedical research and judge the adequacy of research proposals within the context of these principles
  • Identify good clinical practices for clinical trials, including the use of standard operating procedures
  • Characterize the fundamentals of informed consent from the ethical, legal, and regulatory perspectives
  • Identify the requirements and procedures for IRB approval of human subject research, including recent HIPAA regulations

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 25– March 15, 2023

(390.672.71)  Quantitative Analysis of Clinical Data
(Wednesdays, 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.

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.

Course Registration 

A completed registration form, along with full payment, is required to secure your space; registration forms will not be processed without payment.

You will receive an e-mail confirmation prior to the start of the course.

  1. SOCI Training Program candidates (non-credit): JHU Faculty and Staff please register via this registration form.  JHU Post-doctoral Fellows please register via this registration form.
  2. JHU degree-seeking students: all JHU degree candidates registering for academic credit must register via the Office of Records and Registration web registration services here.


Tuition remission is available for all full time JHU faculty and staff.  When completing the Tuition Remission Form, please select "Non-Credit Professional Development" as the course type and "Public Health-Non Credit-Professional Development-100%" for course offered.  A supervisor's signature and a departmental budget number are required or your form will not be processed.  A signature is required to verify that the course is for "professional development" and the budget number is required because your department will be charged if you register for a course and do not complete the course.  Students must withdraw before the end of the add/drop period to avoid this charge. 

Fellows and residents who will be sponsored by their department/division, please make sure you include both the budget number and fund number in the payment section of the Registration Form.

Course Cancellation Policy

JHU reserves the right to cancel or postpone any activity due to unforeseen circumstances.  In this event, the university will refund the registration fee but is not responsible for travel expenses.