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Stephany Duda, PhD and Paul Harris, PhD

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.

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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.

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What's inside

Syllabus

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.
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Traffic lights

Read about what's good
what should give you pause
and possible dealbreakers
Develops foundational knowledge and skills in clinical research data management from the ground up
Provides practical examples and hands-on exercises to solidify understanding and promote skill development
Taught by two expert instructors in clinical research and data management: Stephany Duda, PhD, and Paul Harris, PhD
Addresses topics relevant for both beginners and those seeking to enhance their data management skills in clinical research
Covers a comprehensive range of aspects related to data collection, storage, and dissemination in clinical research
Assumes minimal technical knowledge, making it accessible to individuals with diverse backgrounds

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Reviews summary

Practical data management for clinical research

According to learners, this course provides a highly practical and valuable introduction to data management in clinical research. Students say the hands-on REDCap exercises are a major highlight and are immediately applicable to their jobs. The content is often described as well-structured and providing a solid foundation for beginners. While some found certain lectures a bit dry or felt the REDCap part assumed some prior knowledge, the overall feedback is strongly positive, particularly for those working in the field.
Suitable for beginners, but may be too basic for some.
"Overall solid for a beginner."
"Solid introduction. Covered the fundamentals nicely."
"Not suitable for someone with some existing knowledge."
"The REDCap exercises... assumed some prior familiarity."
Course material is logically organized and covers key areas.
"The content was well-structured, covering everything from planning to post-study activities."
"Good overview of data management principles. Covered the key concepts well."
Hands-on practice with REDCap is a major strength.
"The REDCap exercises were hands-on and invaluable."
"The REDCap hands-on labs were the highlight."
"REDCap part was useful, although sometimes the instructions were a little unclear."
"The REDCap practice was key."
Provides practical skills relevant to clinical research roles.
"This course was incredibly practical and immediately applicable to my job in clinical research."
"Highly practical course for my role in clinical trials."
"Useful for my career."
"I learned how to use practical tools and strategies that I could apply immediately to my work."
Some lectures were found to be less engaging.
"The course covers important topics, but some lectures felt a bit dry."

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 Data Management for Clinical Research with these activities:
Review the course materials on data management in clinical research
Reviewing the course materials can help you solidify your understanding of the principles and practices of data management in clinical research.
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  • Go over the course notes and slides
  • Rewatch the course videos
  • Review the assigned readings
Compile a resource list of data management tools and resources
Compiling a list of data management tools and resources can help you identify the tools that are most appropriate for your research projects.
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Show steps
  • Search for data management tools and resources online
  • Create a list of the tools and resources that you find
  • Organize the list by category or type of tool
Join a study group or discussion forum on data management in clinical research
Participating in a study group or discussion forum can provide you with an opportunity to discuss data management principles and practices with other students.
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  • Find a study group or discussion forum on data management in clinical research
  • Join the group or forum and participate in the discussions
Five other activities
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Take an online course on data management in clinical research
Taking an online course can help you gain a foundational understanding of the principles and practices of data management in clinical research.
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Show steps
  • Find an online course on data management in clinical research
  • Enroll in the course and complete the coursework
Attend a workshop on data management in clinical research
Attending a workshop can provide you with an opportunity to learn from experts in the field of data management in clinical research.
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Show steps
  • Find a workshop on data management in clinical research
  • Register for the workshop and attend the sessions
Create a structured data management plan for a clinical research study
Drafting a structured data management plan will help solidify your understanding of the principles and practices of data management in clinical research.
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  • Identify the data that will be collected during the study
  • Determine how the data will be collected, stored, and processed
  • Develop a system for managing the data, including data security and privacy
  • Write a data management plan that outlines the plan for managing the data
Design and implement an electronic data capture system for a clinical research study
Building an electronic data capture system will provide you with practical experience in applying data management principles to a real-world research project.
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  • Choose an electronic data capture software platform
  • Design the electronic data capture forms
  • Implement the electronic data capture system
  • Test the electronic data capture system
  • Train the study staff on how to use the electronic data capture system
Develop a data analysis plan for a clinical research study
Developing a data analysis plan will help you think critically about the data you will collect and how you will analyze it to answer your research questions.
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  • Identify the research questions that the study will address
  • Determine the data that will be collected to answer the research questions
  • Describe the statistical methods that will be used to analyze the data

Career center

Learners who complete Data Management for Clinical Research will develop knowledge and skills that may be useful to these careers:
Clinical Data Manager
Clinical Data Managers closely oversee the handling of data from the very start of a clinical trial. They maintain and oversee the quality of clinical data from collection to analysis. The course gives a structured overview of the principles of clinical data management, which would be highly useful to someone in this role, particularly early in their career.
Medical Writer
Medical Writers prepare medical documents meant for peers or the public. This typically includes writing protocols, reports, and abstracts, as well as literature reviews, grant proposals, and other scientific documentation. Learning data management principles and best practices would be of great value to a medical writer, and this course would provide a solid foundation for those just starting out, as well as those looking to advance in this career.
Biostatistician
Biostatisticians apply statistics to biological data. This course would help provide a deeper understanding of the principles and practices behind data management, a key part of biostatistical work.
Health Informatics Specialist
Health Informatics Specialists collect, store, and analyze health information. They use a combination of technical and clinical knowledge to manage data. This course would be a great help for those getting started in this growing field.
Clinical Research Associate
Clinical Research Associates serve as liaisons between sponsors, investigators, and research participants. They play a key role in managing and monitoring clinical trials. They manage budgets, timelines, and relationships in service of data collection completion. This course would be helpful for those just starting out in this role by providing a structured and detailed overview of data management in clinical research.
Data Analyst
Data Analysts clean, organize, and interpret data, helping businesses make decisions. This course would help those starting out in data analysis better understand the importance of data management practices, especially as they relate to clinical research.
Quality Assurance Specialist
Quality Assurance Specialists ensure that products and services meet quality standards. This course goes over essential quality control processes in data management, and would be especially useful to those early in their career.
Project Manager
Project Managers plan, execute, and close projects. They typically manage budgets, timelines, and deliverables, and ensure that projects meet quality standards. This course provides a good overview of data management that would be useful in any project management role.
Research Scientist
Research Scientists conduct and interpret scientific research. They typically specialize in a particular field, such as biology, chemistry, or physics. This course would be helpful because it provides an overview of how to manage data in a clinical research setting, and would be useful to scientists considering a career in clinical research or who work with a team of clinicians.
Epidemiologist
Epidemiologists investigate the causes and distribution of disease in populations. They use data to make recommendations for preventing and controlling disease. This course goes over the basics of data management, which would be useful to an epidemiologist, particularly early in their career.
Medical Science Liaison
Medical Science Liaisons serve as a bridge between pharmaceutical companies and healthcare professionals. They provide information about new drugs and treatments to doctors and other healthcare professionals. This course would be helpful for those starting out in this role by providing a structured overview of data management in clinical research, and providing insights into data management on the pharmaceutical industry side.
Regulatory Affairs Specialist
Regulatory Affairs Specialists ensure that products and services comply with government regulations. This course would help those just starting out in this role better understand the importance of data management practices, especially as they relate to clinical research.
Clinical Research Coordinator
Clinical Research Coordinators assist with the day-to-day operations of clinical trials. They may be responsible for recruiting and screening participants, collecting and managing data, and monitoring participant safety. This course provides a structured and detailed overview of data management practices in clinical research, which would be helpful to someone just starting out in this role.
Data Entry Clerk
Data Entry Clerks input and manage data. They ensure that data is accurate and complete. This course would be helpful for someone just starting out in this role by providing a clear overview of the data entry process and quality standards in clinical research.
Database Administrator
Database Administrators manage and maintain databases. They ensure that data is stored securely and efficiently. This course would be helpful for those just starting out in this role by providing a structured overview of data management practices, including data storage and security.

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 Data Management for Clinical Research.
Provides real-world experiences and illustrative examples, which will help learners of this course gain a deep understanding of data management practices at various stages of clinical trials.
Offers a comprehensive guide to data management for clinical research studies. It provides valuable insights into data management planning, documentation, and regulatory compliance.
Similar to the previous book, this text offers a broader perspective on clinical trials but also includes a chapter on data management, providing additional information on data collection, storage, and analysis.
Is more advanced than the previous one on online surveys, providing a comprehensive overview of survey research methods and techniques.
Provides a concise guide to clinical data management, covering all aspects of the process from data collection to analysis. It valuable resource for anyone involved in clinical research.

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