Data Collection and Management Systems for Clinical Research
Many human subject-based research studies will require collection of new data. As such, this course begins by introducing the spectrum of approaches for collecting prospective data, beginning with the limitations of simple spreadsheets and culminating with modern web-based electronic data capture systems (e.g., the free-of-charge REDCap platform and other commercial software). All research studies, no matter if using newly collected or previously collected data, must be able to securely store their data, query it, and prepare it for statistical analysis. Accordingly, this course will explain the limitations of simple spreadsheets for these tasks and spend the bulk of the sessions describing relational database management systems (RDBMSs). To use RDBMSs, researchers must grasp a small but key set of data management principles, which will be illustrated with the most popular desktop RDBMS, Microsoft Access. Learning how to create data collection systems in REDCap and relational databases in Access, students will be well positioned to begin their own data collection and management. Using this conceptual and practical foundation, the course also introduces students how to create a data management plan both for grant applications and ongoing projects.
At the conclusion of this course, students will:
- Be capable of creating on-screen data collection systems using REDCap;
- Understand the basics of the Relational Database Model, including key concepts such as tables, records, fields, data types, relationships, and primary/foreign keys; and
- Know the basics of querying a multi-table, relational database using SQL; and
- Be capable of planning (and budgeting) for data management in a research study.
Each week, for seven weeks, curricular material is introduced with a lecture and accompanying reading. Weekly homework problems lead students through the application of this material. Weekly computer lab sessions give students the opportunity to practice, ask questions, and interact with course faculty.
- Lectures: Each week, a pre-recorded lecture provides an overview of the
curricular material for the week. These begin on Thursday, July 30. The videos are available on the course's website and can be viewed at the student's convenience.
- Computer Labs: The computer lab will be maximally staffed with course faculty in the 8:30 AM to 10 AM time slot on Thursdays, beginning July 30. An additional computer lab will be available from 6:00 PM to 7:30 PM. All computer labs session s will convene by Zoom webconferencing software.
All course materials and handouts will be posted on the course's online syllabus.
"Chapter 16: Data Management" by MA Kohn in Designing Clinical Research by Stephen B Hulley, et al. Wolters Kluwer. 4th Edition. 2013.
Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).
Microsoft Access will be used for several assignments. The software is not available for the MAC, but version 2010 or higher can be used on the PC. For students who do not already own the software, it can be used via MyResearch, which is a secure data hosting service for UCSF researchers. In addition to providing secure, HIPAA-compliant storage for research study data, MyResearch provides remote-desktop access to several applications including Microsoft Access. We will submit the initial account request for all students enrolled in EPI 218, but you must sign an online "attestation form" prior to receiving your login ID.
By the first session in the course, you should have tested your MyResearch account and ensured that you can log in. Please note that MyResearch limits free storage to 5 gigabytes of data. Students will be responsible for any charges that incur for data storage beyond this limit, but the storage requirement for the course will be less than 0.1 gigabytes.
REDCap is a web-based research data collection system developed by an academic consortium based at Vanderbilt University. REDCap enables researchers to build browser-based data entry forms, surveys, and surveys with attached private data entry forms. The survey builder is similar to SurveyMonkey or Qualtrics. As with MyResearch, REDCap is available through UCSF Academic Research Systems, and we will submit your initial account request. The same online attestation form required for MyResearch applies to REDCap. You must have a functional REDCap log-in prior to the 2nd session of the course.
To apply for this course, please fill out and submit the application below. Please see our fee page for cost information. The deadline for application is July 13, 2020. Only one application needs to be completed for all courses desired during the quarter.
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