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Science of Clinical Investigation Training Program

Course Logistics and Content

To earn the SOCI Achievement Award, participants must satisfactorily complete four courses - two required courses and (at least) two electives. 

Course Requirements

  • Each course must be taken non-credit.
  • 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.
  • Courses can be taken on-campus, online, or a combination of the two (on-campus courses are held at the BSPH in Baltimore). 

The BSPH Academic Year consists of four 8-week terms. Please view the current Academic Year Calendar.

The 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.

The 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.

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 Bloomberg School. Please view the IOL schedule and register as soon as possible.   

390.676 Design of Clinical Studies (non-credit, only open to SOCI Award candidates)

  • 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 (non-credit, only open to SOCI Award candidates)

  • 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 the 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 

Elective Courses 

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

390.677 Database Design and Implementation in Clinical Research 

  • Construct a database environment for efficient storage and access to 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 

  • Reflect on the fundamental ethical principles that govern biomedical research and judge whether research proposals adhere to 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 

  • 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 of research
  • Identify the implications of outcomes and effectiveness studies for end-users

390.678 Quality Improvement and Knowledge Translation 

  • 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

Course Schedule

The BSPH Academic Year consists of four 8-week terms. Please view the current Academic Year Calendar.

 

Summer Term (July)

 
390.677.71 Database Design of Clinical Studies Mon-Thurs, 5:00-7:00 pm Instruction - synchronous via Zoom, real time

First Term (September-October)

 
390.673.71 Ethical and Regulatory Issues in Clinical Research Mondays, 5:30-7:30 pm Instruction - synchronous via Zoom, real time
390.678.81 Quality Improvement and Knowledge Translation Instruction – Asynchronous Online

Second Term (October-December)

 
390.676.71 Design of Clinical Studies  Mondays, 5:30-7:30 pm Instruction - synchronous via Zoom, real time
390.673.81 Ethical and Regulatory Issues in Clinical Research Instruction – Asynchronous Online

Third Term (January-March)

 
390.672.71 Quantitative Analysis of Clinical Studies    Mondays, 6:30-8:30 pm Instruction - synchronous via Zoom, real time
390.676.81 Design of Clinical Studies  Instruction – Asynchronous Online

Fourth Term (March-May)

 
390.675.71 Outcomes and Effectiveness Research Mondays, 5:30-8:30 pm Instruction - synchronous via Zoom, real time
390.672.81 Quantitative Analysis of Clinical Studies   Instruction – Asynchronous Online

Course Registration 

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

A confirmation email, with course details, is sent 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.

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.