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Clinical Trials Data Management and Quality Assurance

Janet Holbrook, PhD, MPH, Ann-Margret Ervin, PhD, MPH, and David M. Shade, JD

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.

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Syllabus

Data Collection Instruments
This module covers the design and organization of data collection instruments to be used in a clinical trial. A well-designed data collection instrument is critically important to the success of a trial because it determines the way that the data are defined, collected, and organized. A study without a well-designed data collection instrument is likely to encounter otherwise avoidable problems.
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Traffic lights

Read about what's good
what should give you pause
and possible dealbreakers
Teaches performance monitoring, which clinical research professionals use to track and improve the progress of studies
Taught by Janet Holbrook, PhD, MPH; David M. Shade, JD; and Ann-Margret Ervin, PhD, MPH, who have extensive experience in clinical data management
Covers data integrity, which is essential for ensuring the accuracy and reliability of clinical trial data
Explores different types of data management systems, helping learners make informed decisions about the best system for their needs
Requires some background knowledge in clinical research, which may be a barrier for some learners
Does not cover data analysis, which is a key aspect of clinical trial data management

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Reviews summary

Clinical trials data management essentials

According to learners, this course provides a solid foundation in clinical trials data management, emphasizing quality assurance. Many found the content well-structured and applicable to professional work, highlighting its value for those seeking to formalize their knowledge. While effective for beginners, some experienced professionals found the course lacked depth, particularly with its basic examples and limited coverage of modern data management systems. Recent feedback suggests a desire for more advanced content and tools.
Ideal for beginners, but potentially slow for experts.
"For someone with prior experience, it might feel a bit slow."
"It's definitely for those new to the field or looking to formalize their knowledge."
"I think it's a great course for beginners, but experienced professionals might find some parts redundant."
Effectively covers critical QA and monitoring practices.
"The detailed discussions on data integrity and performance monitoring were exactly what I needed."
"The emphasis on quality assurance was very valuable."
"The quality assurance section alone was worth the enrollment."
Focuses on real-world scenarios and direct applicability.
"The content was directly applicable to my work. I particularly appreciated the practical examples and the focus on quality assurance."
"Absolutely fantastic! The course covers all the essential aspects of clinical data from collection to quality control."
"Highly practical and relevant! It's great to have a course that focuses on real-world applications in clinical trials."
A comprehensive and clear introduction to core concepts.
"This course is incredibly well-structured and provides a solid foundation in data management for clinical trials."
"Good course for understanding the basics of clinical trial data. The information was comprehensive."
"I learned a lot about the intricacies of data collection and monitoring. The course is well-structured and the concepts are presented clearly."
Relies on basic tools and lacks modern system discussion.
"The Excel examples were basic. I was hoping for more advanced data management tools or more complex scenarios."
"The course felt a bit outdated in its approach, especially regarding data management systems. I would have liked to see more on modern EDC systems rather than just Excel."
"It's a good foundation, but don't expect deep dives into advanced statistical software or programming."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Clinical Trials Data Management and Quality Assurance with these activities:
Review clinical trial ethics
Reviewing clinical trial ethics will help you understand the ethical considerations and guidelines that are essential in conducting clinical trials.
Browse courses on Informed Consent
Show steps
  • Read the Belmont Report and the Declaration of Helsinki
  • Discuss the principles of informed consent with a colleague
  • Consider the ethical implications of different clinical trial designs
Review Statistical Methods for Clinical Trials
This book provides a comprehensive overview of the statistical methods used in clinical trials, and will help you understand the statistical principles underlying the design, conduct, and analysis of clinical trials.
View Fundamentals of Clinical Trials on Amazon
Show steps
  • Read Chapters 1-3 to understand the basic concepts of clinical trial statistics
  • Work through the examples in Chapters 4-6 to practice applying statistical methods to clinical trial data
  • Discuss the statistical methods used in your own clinical trial with a statistician
Practice calculating sample size
Practicing calculating sample size will help you understand how to determine the appropriate number of participants for your clinical trial.
Browse courses on Sample Size Calculation
Show steps
  • Use a sample size calculator to calculate the sample size for a variety of different scenarios
  • Discuss your sample size calculations with a statistician
Five other activities
Expand to see all activities and additional details
Show all eight activities
Follow a tutorial on data management in clinical trials
Following a tutorial on data management will help you understand the principles of data management in clinical trials, and how to ensure the integrity of your data.
Browse courses on Data Management
Show steps
  • Search for a tutorial on data management in clinical trials
  • Follow the steps in the tutorial to learn about the different aspects of data management
  • Apply the principles of data management to your own clinical trial
Join a peer group for clinical trial investigators
Joining a peer group will provide you with the opportunity to connect with other clinical trial investigators and share experiences and advice.
Browse courses on Peer Support
Show steps
  • Search for a peer group for clinical trial investigators
  • Join the group and introduce yourself
  • Participate in discussions and ask questions
Attend a workshop on clinical trial quality assurance
Attending a workshop on clinical trial quality assurance will help you understand the principles of quality assurance in clinical trials, and how to implement quality assurance measures in your own trial.
Browse courses on Data Quality Management
Show steps
  • Search for a workshop on clinical trial quality assurance
  • Attend the workshop and take notes
  • Apply the principles of quality assurance to your own clinical trial
Mentor a junior clinical trial investigator
Mentoring a junior clinical trial investigator will help you to reinforce your knowledge of clinical trial conduct, and to develop your leadership skills.
Browse courses on Mentoring
Show steps
  • Identify a junior clinical trial investigator who you can mentor
  • Meet with your mentee regularly to provide guidance and support
  • Help your mentee to develop their clinical trial skills
Contribute to an open-source clinical trial data management platform
Contributing to an open-source clinical trial data management platform will help you to develop your technical skills and to make a contribution to the clinical trial community.
Browse courses on Open Source
Show steps
  • Identify an open-source clinical trial data management platform that you can contribute to
  • Contact the project maintainers and express your interest in contributing
  • Make a contribution to the project

Career center

Learners who complete Clinical Trials Data Management and Quality Assurance will develop knowledge and skills that may be useful to these careers:
Clinical Data Manager
A Clinical Data Manager is responsible for managing the collection, storage, and analysis of clinical data. This course can help you build a foundation in clinical data management by teaching you how to design and organize data collection instruments, manage data, and perform performance monitoring. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Clinical Data Manager
Quality Assurance Specialist
A Quality Assurance Specialist is responsible for ensuring that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines. This course can help you build a foundation in quality assurance by teaching you about the principles of quality assurance, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Quality Assurance Specialist
Clinical Research Associate
A Clinical Research Associate (CRA) is responsible for managing the day-to-day operations of a clinical trial. This course can help you build a foundation in clinical research by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Clinical Research Associate
Data Analyst
A Data Analyst is responsible for collecting, cleaning, and analyzing data. This course can help you build a foundation in data analysis by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Data Analyst
Biostatistician
A Biostatistician is responsible for designing and analyzing clinical trials. This course can help you build a foundation in biostatistics by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Biostatistician
Medical Writer
A Medical Writer is responsible for writing clinical trial protocols, reports, and other documents. This course can help you build a foundation in medical writing by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Medical Writer
Regulatory Affairs Specialist
A Regulatory Affairs Specialist is responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements. This course can help you build a foundation in regulatory affairs by teaching you about the principles of quality assurance, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Regulatory Affairs Specialist
Project Manager
A Project Manager is responsible for planning, organizing, and executing clinical trials. This course can help you build a foundation in project management by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Project Manager
Clinical Trial Coordinator
A Clinical Trial Coordinator is responsible for coordinating the day-to-day operations of a clinical trial. This course can help you build a foundation in clinical trial coordination by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Clinical Trial Coordinator
Clinical Research Scientist
A Clinical Research Scientist is responsible for conducting clinical trials. This course can help you build a foundation in clinical research by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Clinical Research Scientist
Investigator
An Investigator is responsible for conducting clinical trials. This course can help you build a foundation in clinical research by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Investigator
Site Manager
A Site Manager is responsible for managing a clinical trial site. This course can help you build a foundation in site management by teaching you about the principles of clinical trial management, how to conduct performance monitoring, and how to manage treatment interventions. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Site Manager
Data Entry Clerk
A Data Entry Clerk is responsible for entering data into a clinical trial database. This course can help you build a foundation in data entry by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills will be essential for success in this role.
See salaries and explore the career path for Data Entry Clerk
Laboratory Technician
A Laboratory Technician is responsible for performing laboratory tests in a clinical trial. This course may help you build a foundation in laboratory testing by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills may be helpful for success in this role.
See salaries and explore the career path for Laboratory Technician
Pharmacist
A Pharmacist is responsible for dispensing medications in a clinical trial. This course may help you build a foundation in pharmacy by teaching you about data management, data assembly and distribution, and performance monitoring. This knowledge and skills may be helpful for success in this role.
See salaries and explore the career path for Pharmacist

Reading list

We've selected six books that we think will supplement your learning. Use these to develop background knowledge, enrich your coursework, and gain a deeper understanding of the topics covered in Clinical Trials Data Management and Quality Assurance.
Cover image
Metrics That Matter for Population Health Action
Save
Provides a practical guide to quality assurance in clinical trials. It covers all aspects of quality assurance, from planning and design to monitoring and reporting.
Metrics That Matter for Population Health Action:...
Paperback
$$$
Metrics That Matter for Population Health Action:...
Kindle Edition
$$
Cover image
Medical Informatics in a United and Healthy Europe
Save
Provides a comprehensive overview of Good Clinical Practice (GCP) guidelines. It would be a useful reference for anyone involved in clinical research.
Medical Informatics in a United and Healthy Europe
Paperback
Check
Medical Informatics in a United and Healthy Europe
Kindle Edition
Check
Cover image
A Ready and Resilient Workforce for the Department...
Save
Serves as a practical guide to clinical trial data management, covering best practices, regulatory compliance, and quality assurance. Provides essential knowledge for data managers and other professionals involved in clinical research.
A Ready and Resilient Workforce for the Department...
Kindle Edition
$$
Cover image
Medical Statistics
Save
Provides a comprehensive overview of statistical methods used in clinical trials. It would be a useful reference for anyone involved in clinical data management or statistics.
Medical Statistics: A Textbook for the Health...
Paperback
$$
Medical Statistics: A Textbook for the Health...
Paperback
$$$
Medical Statistics: A Textbook for the Health...
Kindle Edition
$$
Cover image
Clinical Trials
Save
Is more valuable as additional reading than it is as a current reference. It provides a methodologic perspective on clinical trials and is helpful for understanding the principles and practices of clinical research.
Clinical Trials: A Methodologic Perspective (Wiley...
Kindle Edition
$$$$
Clinical Trials: A Methodologic Perspective (WILEY...
Hardcover
$$$$
Clinical Trials: A Methodologic Perspective Second...
Hardcover
$$$$
Principles and Practice of Clinical Trials
Hardcover
$$$$
Clinical Trials: A Methodologic Perspective (Wiley...
Hardcover
$$
Cover image
Statistical Issues in Drug Development
Save
Provides a comprehensive overview of the principles and practices of statistical methods in clinical trials, and valuable resource for anyone involved in the analysis of clinical research data.
Statistical Issues in Drug Development
Paperback
Check
Statistical Issues in Drug Development
Kindle Edition
Check

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Course image
Effort
4 weeks, 1-2 hours per week
Level
Introductory
Via
Coursera
Institution
Johns Hopkins University
Instructors
Janet Holbrook, PhD, MPH
Ann-Margret Ervin, PhD, MPH
David M. Shade, JD
Language
English
Transcripts
Español Français Português Deutsch Italiano 中文 العربية 한국어 日本語 हिंदी Nederlands Svenska Pусский Türkçe Polski Ελληνικά українська мова Bahasa Indonesia ไทย қазақша
This course belongs to a collection called Clinical Trials Operations. It's comprised of four courses:
  1. Clinical Trials Analysis, Monitoring, and Presentation
  2. Clinical Trials Management and Advanced Operations
  3. Design and Conduct of Clinical Trials
  4. Clinical Trials Data Management and Quality Assurance (viewing)
Traffic lights
Read about what's good
what should give you pause
and possible dealbreakers
Teaches performance monitoring, which clinical research professionals use to track and improve the progress of studies
Taught by Janet Holbrook, PhD, MPH; David M. Shade, JD; and Ann-Margret Ervin, PhD, MPH, who have extensive experience in clinical data management
Covers data integrity, which is essential for ensuring the accuracy and reliability of clinical trial data
Explores different types of data management systems, helping learners make informed decisions about the best system for their needs
Requires some background knowledge in clinical research, which may be a barrier for some learners
Does not cover data analysis, which is a key aspect of clinical trial data management
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