Data Management for Clinical Research

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Data Management for Clinical Research

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Beschreibung

When you enroll for courses through Coursera you get to choose for a paid plan or for a free plan

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About this course: 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 p…

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When you enroll for courses through Coursera you get to choose for a paid plan or for a free plan

  • Free plan: No certicification and/or audit only. You will have access to all course materials except graded items.
  • Paid plan: Commit to earning a Certificate—it's a trusted, shareable way to showcase your new skills.

About this course: 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.

Created by:  Vanderbilt University
  • Taught by:  Stephany Duda, PhD, Assistant Professor

    Department of Biomedical Informatics
  • Taught by:  Paul Harris, PhD, Professor

    Biomedical Informatics and Biomedical Engineering
Level Beginner Commitment 6 weeks of study, 2-4 hours per week Language English How To Pass Pass all graded assignments to complete the course. User Ratings 4.6 stars Average User Rating 4.6See what learners said Coursework

Each course is like an interactive textbook, featuring pre-recorded videos, quizzes and projects.

Help from your peers

Connect with thousands of other learners and debate ideas, discuss course material, and get help mastering concepts.

Certificates

Earn official recognition for your work, and share your success with friends, colleagues, and employers.

Vanderbilt University Vanderbilt University, located in Nashville, Tenn., is a private research university and medical center offering a full-range of undergraduate, graduate and professional degrees.

Syllabus


WEEK 1


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 videos, 1 reading expand


  1. Video: How the Course Works
  2. Video: Course Introduction
  3. Video: Defining the Space
  4. Reading: Course Logistics
  5. Discussion Prompt: What is your background in this area?
  6. Video: Research Data Planning 1
  7. Video: Research Data Planning 2
  8. Video: Approaches to Data Collection

Graded: Quiz 1
Graded: Assignment 1 - Survey Question Critique

WEEK 2


Electronic Data Capture Fundamentals
This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.


9 videos expand


  1. Video: Standardization of Study Processes
  2. Video: Validated Instruments
  3. Video: Data Standards: What Can Standards Do for You?
  4. Video: Data Standards: Basic Concepts and Overview
  5. Discussion Prompt: What standards have you used?
  6. Video: IRB, HIPAA, and FISMA
  7. Video: GCP and 21 CFR Part 11
  8. Video: Introduction to Electronic Data Capture (EDC)
  9. Video: EDC Concepts: Data Exports, Logging, User Rights, Project Creation
  10. Video: EDC Concepts: Data Imports, Scheduling, Reports, Internationalization

Graded: Quiz 2

WEEK 3


Planning a Data Strategy for a Prospective Study
This module reviews the process of planning data elements for a real-world research study.


9 videos expand


  1. Video: Overview of the Study
  2. Video: Study Procedures
  3. Video: Baseline Data and Demographics
  4. Video: Visit Data
  5. Video: Review of Variables and Forms
  6. Discussion Prompt: How have you assembled a study data management plan?
  7. Video: Logging in to REDCap
  8. Video: Walkthrough: Creating a Project and Adding the First Variables
  9. Video: Walkthrough: Adding Fields to the Baseline Form
  10. Video: Walkthrough: Adding File Fields and Formatting

Graded: Quiz 3

WEEK 4


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 videos expand


  1. Video: Walkthrough: Creating Visit Forms
  2. Video: Walkthrough: Copying Variables, Renaming Forms
  3. Video: Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights
  4. Video: Walkthrough: Testing the REDCap Project
  5. Video: Example Study Wrap-Up
  6. Video: Mid Study Activities 1
  7. Video: Mid Study Activities 2
  8. Video: Data Quality
  9. Video: Data Quality Monitoring
  10. Discussion Prompt: What data quality challenges have you encountered?

Graded: Assignment 2 - First REDCap Assignment
Graded: Quiz 4

WEEK 5


Post-Study Activities and Other Considerations



In this week, we cover activities to wrap up your study and share data and results, as well as two lectures on other electronic sources of data that can be used in research. In response to learner requests, we've also added several lectures on clinical data management in resource-limited settings, in collaboration with research colleagues from Indiana University. This is a long week of videos, but next week will be short on videos in exchange!


12 videos expand


  1. Video: Wrapping Up Your Study
  2. Video: Sharing Your Work
  3. Video: De-identifying Data
  4. Video: De-identifying Dates
  5. Video: Common Information Systems Used in Health Care
  6. Video: Neuroimaging Data Management
  7. Video: mHealth in Developing Countries
  8. Discussion Prompt: What health care information systems have you worked with?
  9. Video: Data Management for Multi-Center or Network Studies
  10. Video: Resource-Limited Settings and Global Health
  11. Video: Challenges of Collecting Data in Resource-Constrained Settings
  12. Video: Data Privacy in Global Research
  13. Video: International Data Sharing

Graded: Quiz 5

WEEK 6


Data Collection with Surveys
In the final week, we cover how to collect data using surveys and review an example together. This week's assignment includes designing, distributing, and reporting on your own survey.


7 videos expand


  1. Video: Benefits, Scope, and Validated Instruments
  2. Video: Survey Design
  3. Video: Survey Procedures and Implementation
  4. Video: Survey Testing, Administration, and Analysis
  5. Video: Survey Overview and REDCap Setup
  6. Video: Survey Testing and Distribution
  7. Discussion Prompt: Share Assignment 3 survey links (optional)
  8. Video: Thank you for participating!

Graded: Week 6 Quiz
Graded: Assignment 3 - Build, Deploy, and Report on a Survey

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