Clinical Trials Data Management and Quality Assurance
In this course, you’ll learn to collect and care for the data gathered during your trial and how to prevent mistakes and errors through quality assurance practices. Clinical trials generate an enormous amount of data, so you and your team must plan carefully by choosing the right collection instruments, systems, and measures to protect the integrity of your trial data. You’ll learn how to assemble, clean, and de-identify your datasets.
Monthly Subscription Starting at AED 99 + VAT
- Level Foundation
- المدة 7 ساعات hours
- الطبع بواسطة Johns Hopkins University
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Offered by
عن
In this course, you’ll learn to collect and care for the data gathered during your trial and how to prevent mistakes and errors through quality assurance practices. Clinical trials generate an enormous amount of data, so you and your team must plan carefully by choosing the right collection instruments, systems, and measures to protect the integrity of your trial data. You’ll learn how to assemble, clean, and de-identify your datasets. Finally, you’ll learn to find and correct deficiencies through performance monitoring, manage treatment interventions, and implement quality assurance protocols.الوحدات
Welcome
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1
Readings
1
Readings
- Welcome to the Course
Data Collection Instruments
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6
Videos
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1
Assignment
1
Assignment
- Data Collection Instruments
6
Videos
- Definitions and Introduction
- General Principles
- Design Considerations
- Data Collection Instrument (DCI) and Database Interactions
- Data Collection Instrument (DCI) Revisions
- Other Data Collection Instrument (DCI) Issues
Data Management
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5
Videos
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1
Assignment
1
Assignment
- Data Management
5
Videos
- Definitions and Overview
- Database Systems
- Excel
- External Data
- Data Integrity
Data Assembly and Distribution
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5
Videos
-
1
Assignment
1
Assignment
- Data Assembly and Distribution
5
Videos
- Data Freeze and Data Lock
- Data Cleaning
- De-Identification
- Data Sharing
- Data Standards
Performance Monitoring
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3
Videos
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1
Assignment
1
Assignment
- Performance Monitoring
3
Videos
- Introduction to Performance Monitoring
- Performance Monitoring by Trial Stage
- Site Visits
Intervention Management
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4
Videos
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1
Assignment
1
Assignment
- Intervention Management
4
Videos
- Principles of Management of Treatment Interventions
- Masking Interventions
- Example: Asthma Trial
- Managing Treatment Supplies
Quality Assurance
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6
Videos
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1
Readings
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1
Assignment
1
Assignment
- Quality Assurance
6
Videos
- Definitions and Introduction
- Trial Design Phase
- Trial Preparation Phase
- Trial Execution Phase
- Trial Conclusion Phase
- Conclusion
1
Readings
- Closing Thoughts
Auto Summary
Embark on a comprehensive journey into the realm of data management and quality assurance within clinical trials with this foundational course tailored for health and fitness enthusiasts. Guided by expert instructors from Coursera, this course delves into the meticulous processes of collecting, caring for, and safeguarding trial data against errors. Participants will master the art of selecting appropriate data collection instruments and systems to maintain the integrity of their data. The curriculum covers essential skills such as assembling, cleaning, and de-identifying datasets, as well as performance monitoring, managing treatment interventions, and implementing robust quality assurance protocols. Spanning 420 minutes, this course is ideal for beginners seeking to build a solid foundation in clinical trials data management. Enroll with a Starter subscription to gain the necessary expertise to excel in this critical domain.
Janet Holbrook, PhD, MPH
Ann-Margret Ervin, PhD, MPH
David M. Shade, JD