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This course introduces critical concepts and practical methods for clinical research data planning, collection, storage, and dissemination. Understanding and applying sound data management principles is essential in any scientific domain. Whatever your current (or anticipated) role in the research enterprise, a solid working knowledge and skill set in data management principles and practise will boost your productivity and improve your science. Our intention is to use these modules to assist you in learning and practising this skill set. Other than knowing how to use a web browser, this course assumes very little current knowledge of technology. As we explore best practises for data management together, we will focus on practical lessons, short quizzes, and hands-on exercises.
Syllabus :
1. Research Data Collection Strategy
- Defining the Space
- Research Data Planning
- Approaches to Data Collection
2. Electronic Data Capture Fundamentals
- Standardization of Study Processes
- Validated Instruments
- What Can Standards Do for You?
- Basic Concepts and Overview
- IRB, HIPAA, and FISMA
- GCP and 21 CFR
- Introduction to Electronic Data Capture (EDC)
- Data Exports, Logging, User Rights, Project Creation
- Data Imports, Scheduling, Reports, Internationalization
3. Planning a Data Strategy for a Prospective Study
- Study Procedures
- Baseline Data and Demographics
- Visit Data
- Review of Variables and Forms
- Logging in to REDCap
- Creating a Project and Adding the First Variables
- Adding Fields to the Baseline Form
- Adding File Fields and Formatting
4. Practicing What We've Learned: Implementation
- Creating Visit Forms
- Copying Variables, Renaming Forms
- Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights
- Testing the REDCap Project
- Mid Study Activities
- Data Quality
- Data Quality Monitoring
5. Post-Study Activities and Other Considerations
- Wrapping Up Your Study
- Sharing Your Work
- De-identifying Data
- De-identifying Dates
- Common Information Systems Used in Health Care
- Neuroimaging Data Management
- mHealth in Developing Countrie
- Data Management for Multi-Center or Network Studies
- Resource-Limited Settings and Global Health
- Challenges of Collecting Data in Resource-Constrained Settings
- Data Privacy in Global Research
- International Data Sharing
6. Data Collection with Surveys
- Benefits, Scope, and Validated Instruments
- Survey Design
- Survey Procedures and Implementation
- Survey Testing, Administration, and Analysis
- Survey Overview and REDCap Setup
- Survey Testing and Distribution
