This course presents critical concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research.
Understanding and implementing solid data management principles is critical for any scientific domain. Regardless of your current (or anticipated) role in the research enterprise, a strong working knowledge and skill set in data management principles and practice will increase your productivity and improve your science. Our goal is to use these modules to help you learn and practice this skill set.
This course assumes very little current knowledge of technology other than how to operate a web browser. We will focus on practical lessons, short quizzes, and hands-on exercises as we explore together best practices for data management.
教学大纲 - 您将从这门课程中学到什么
周
1完成时间为 4 小时
Research Data Collection Strategy
This introductory module reviews the course structure and basic concepts in clinical research. We also discuss best practices for designing your clinical research data collection.
6 个视频 （总计 69 分钟）, 1 个阅读材料, 2 个测验
6 个视频
Course Introduction5分钟
Defining the Space10分钟
Research Data Planning 113分钟
Research Data Planning 224分钟
Approaches to Data Collection8分钟
1 个阅读材料
Course Logistics10分钟
1 个练习
Quiz 116分钟
周
2完成时间为 3 小时
Electronic Data Capture Fundamentals
This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.
9 个视频 （总计 130 分钟）, 1 个测验
9 个视频
Validated Instruments13分钟
Data Standards: What Can Standards Do for You?15分钟
Data Standards: Basic Concepts and Overview15分钟
IRB, HIPAA, and FISMA14分钟
GCP and 21 CFR Part 1111分钟
Introduction to Electronic Data Capture (EDC)17分钟
EDC Concepts: Data Exports, Logging, User Rights, Project Creation12分钟
EDC Concepts: Data Imports, Scheduling, Reports, Internationalization14分钟
1 个练习
Quiz 220分钟
周
3完成时间为 2 小时
Planning a Data Strategy for a Prospective Study
This module reviews the process of planning data elements for a real-world research study.
9 个视频 （总计 92 分钟）, 1 个测验
9 个视频
Study Procedures10分钟
Baseline Data and Demographics13分钟
Visit Data5分钟
Review of Variables and Forms9分钟
Logging in to REDCap2分钟
Walkthrough: Creating a Project and Adding the First Variables16分钟
Walkthrough: Adding Fields to the Baseline Form12分钟
Walkthrough: Adding File Fields and Formatting10分钟
1 个练习
Quiz 314分钟
周
4完成时间为 4 小时
Practicing What We've Learned: Implementation
This week, we set up an Electronic Data Capture (EDC) instrument in REDCap for the Morphine vs. Marinol Study. We also review data processes that occur during the running of a study, including an overview of key data quality operations.
9 个视频 （总计 101 分钟）, 2 个测验
9 个视频
Walkthrough: Copying Variables, Renaming Forms9分钟
Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights17分钟
Walkthrough: Testing the REDCap Project7分钟
Example Study Wrap-Up3分钟
Mid Study Activities 112分钟
Mid Study Activities 215分钟
Data Quality11分钟
Data Quality Monitoring15分钟
1 个练习
Quiz 414分钟
4.7
138 个审阅38%
完成这些课程后已开始新的职业生涯
31%
通过此课程获得实实在在的工作福利
21%
加薪或升职
热门审阅
I find the course helpful and a good introduction into data management. I'm hoping that there is a follow up course to take us further and deeper in planning for a study and data analysis.
I enjoyed the course very much and I learned a lot! I would definitely recommend it to someone that wants to get some background knowledge about clinical research and data management.
讲师
Stephany Duda, PhD
Associate ProfessorDepartment of Biomedical Informatics
Paul Harris, PhD
ProfessorBiomedical Informatics and Biomedical Engineering
关于 范德堡大学
Vanderbilt University, located in Nashville, Tenn., is a private research university and medical center offering a full-range of undergraduate, graduate and professional degrees.
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