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Database Management Systems for Clinical Research
EPI 218 Winter 2009 (1 unit)



OBJECTIVES

Developing a clinical research study consists of:

  1. choosing a study design, and defining the study population, the predictor variables, and the outcome variables;
  2. planning the measurement of these variables and anticipating problems with the measurements; and
  3. outlining the analysis and estimating sample size.

Inevitably, baseline data on the individuals in the study population and measurements of the predictor and outcome variables will reside in a computer database. The software that runs this computer database is the database management system (DBMS). Often the amount of actual study information is small compared to the amount of administrative information, such as patient contact information, exam schedules, reimbursement records, etc. The DBMS may also store this administrative information, and it is used to update, check, and correct the data. It will also be used either to analyze the study data or to format the data for export to a statistical analysis package. Just as the clinical investigator must plan (and budget for) statistical analysis, she 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 planning (and budgeting for) data management in a research study

The example used throughout this course is the "Infant Jaundice Study", a fictional cohort study of the association between neonatal jaundice and neuropyschiatric scores at age 5 in children born over a two-year period at a single hospital.

PREREQUISITES

Designing Clinical Research (Epi 202). Exceptions to this prerequisite may be made with the consent of the Course Director, space permitting.

FACULTY

Course Director:

Michael A. Kohn, MD, MPP
Campus Phone: 415-514-8142
email: michael.kohn@ucsf.edu

Teaching Assistants:

Carolyn Calfee, MD
email: carolyn.calfee@ucsf.edu

 

Sarath Raju
email: Sarath.Raju@ucsf.edu


TEXTBOOKS

Learn Microsoft Access 2000 [CD-ROM]. CompuWorks. To be supplied by instructor.

"Chapter 16: Data Management" by MA Kohn in Designing Clinical Research by Stephen B Hulley, et al. Lippincott Williams & Wilkins. 3rd Edition. 2007.

ENROLLMENT

This course is open to a limited number of individuals outside of the ATCR and Master's programs. Preference is given to UCSF-affiliated personnel. We regret that auditing is not permitted. To apply for this course please fill out and submit the application below. Cost and submission information are in the application.

Application (Word doc, 20KB)