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.
教學大綱 - 您將從這門課程中學到什麼
週
1完成時間為 4 小時
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 個視頻 （總計 69 分鐘）, 1 個閱讀材料, 2 個測驗
6 個視頻
Course Introduction5分鐘
Defining the Space10分鐘
Research Data Planning 113分鐘
Research Data Planning 224分鐘
Approaches to Data Collection8分鐘
1 個閱讀材料
Course Logistics10分鐘
1 個練習
Quiz 116分鐘
週
2完成時間為 3 小時
Electronic Data Capture Fundamentals
This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.
9 個視頻 （總計 130 分鐘）, 1 個測驗
9 個視頻
Validated Instruments13分鐘
Data Standards: What Can Standards Do for You?15分鐘
Data Standards: Basic Concepts and Overview15分鐘
IRB, HIPAA, and FISMA14分鐘
GCP and 21 CFR Part 1111分鐘
Introduction to Electronic Data Capture (EDC)17分鐘
EDC Concepts: Data Exports, Logging, User Rights, Project Creation12分鐘
EDC Concepts: Data Imports, Scheduling, Reports, Internationalization14分鐘
1 個練習
Quiz 220分鐘
週
3完成時間為 2 小時
Planning a Data Strategy for a Prospective Study
This module reviews the process of planning data elements for a real-world research study.
9 個視頻 （總計 92 分鐘）, 1 個測驗
9 個視頻
Study Procedures10分鐘
Baseline Data and Demographics13分鐘
Visit Data5分鐘
Review of Variables and Forms9分鐘
Logging in to REDCap2分鐘
Walkthrough: Creating a Project and Adding the First Variables16分鐘
Walkthrough: Adding Fields to the Baseline Form12分鐘
Walkthrough: Adding File Fields and Formatting10分鐘
1 個練習
Quiz 314分鐘
週
4完成時間為 4 小時
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 個視頻 （總計 101 分鐘）, 2 個測驗
9 個視頻
Walkthrough: Copying Variables, Renaming Forms9分鐘
Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights17分鐘
Walkthrough: Testing the REDCap Project7分鐘
Example Study Wrap-Up3分鐘
Mid Study Activities 112分鐘
Mid Study Activities 215分鐘
Data Quality11分鐘
Data Quality Monitoring15分鐘
1 個練習
Quiz 414分鐘
4.7
138 個審閱38%
完成這些課程後已開始新的職業生涯
31%
通過此課程獲得實實在在的工作福利
21%
加薪或升職
熱門審閱
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.
講師
Stephany Duda, PhD
Associate ProfessorDepartment of Biomedical Informatics
Paul Harris, PhD
ProfessorBiomedical Informatics and Biomedical Engineering
關於 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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