EPI 150.03: Designing Clinical Research (One Month) (Summer 2015)

This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research. This is primarily accomplished by instructing students in the creation of a research protocol, which is intended to address a relevant research question in their specific discipline.

The objectives for this course are for participants to:

  • acquire skills for designing and interpreting clinical research;
  • produce a complete clinical research protocol, including background, sampling, measurements, and data analysis; and
  • help others in the class to develop these skills and protocols.

EPI 202: Designing Clinical Research (Two Month) (Summer 2015)

This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research. This is primarily accomplished by instructing students in the creation of a research protocol, which is intended to address a relevant research question in their specific discipline.

EPI 218: Database Management Systems for Clinical Research (Summer 2015)

Inevitably, data in any clinical research study will reside in a computer database. The software that runs this computer database is the database management system (DBMS), which can also be used to store administrative information, such as patient contact information, exam schedules, reimbursement records, etc. Not only does the DBMS store data, it can check data accuracy, analyze the study data, or format the data for export to a statistical analysis package. Just as the clinical investigator must plan (and budget) for statistical analysis, she/he should also plan (and budget) for data management.

At the conclusion of this course, students will:

  • Understand the basics of developing a small, multi-table relational database for a research study;
  • Be capable of designing and developing on-screen data collection forms using Microsoft Access™ and web-based forms using REDCap;
  • Understand the differences between desktop applications such as Access™ and web-based research data collection systems such as REDCap or QuesGen™; and
  • Be capable of planning (and budgeting for) data management in a research study.

BIOSTAT 212: Introduction to Statistical Computing in Clinical Research (Summer 2015)

Performing clinical research in the current era requires the use of computers and a high level of competency in the use of database, spreadsheet, and statistical software programs. This course is designed to introduce you to these programs, prepare you for subsequent courses in the clinical research curriculum, and, in particular, teach you the skills you will need to start exploring your own clinical research data using statistical software.

The specific objectives are to provide students with an introduction to:

  • The roles of spreadsheet, relational database and statistical software packages, such as STATA, in analyzing clinical research data;
  • Using STATA for importing, cleaning, managing, describing and analyzing clinical research data;
  • Applying concepts from other TICR Program courses using STATA and Excel; and
  • Applying these skills to analyzing data from your own research project.