What Does MVP Stand For? It’s Not What You Think.
October 7, 2024
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This course is part of Clinical Trials Operations Specialization
Instructors: Ann-Margret Ervin, PhD, MPH
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(85 reviews)
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Beginner level
Learners should have some familiarity with basic scientific, statistical, and management concepts.
(85 reviews)
Recommended experience
Beginner level
Learners should have some familiarity with basic scientific, statistical, and management concepts.
Detect and respond to protocol events
Recognize and respond to misconduct
Safeguard participant safety and trial integrity
Develop and maintain study documents
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In this course, you’ll learn about the more advanced elements of managing clinical trials. From anticipating and planning for protocol events to conducting systematic reviews to synthesize evidence, you and your study team need the skills to implement best practices throughout the trial process. You’ll learn how to recognize and respond to problems and adverse events, comply with regulations, and participate in frameworks that promote transparency. You’ll also learn how systematic review and meta-analysis is used to synthesize evidence from multiple sources. Finally, you’ll learn how your research can benefit from the adoption and consistent use of standardized study documents.
Protocol events are problems of varying magnitude that happen over the course of a clinical trial. They can affect patient safety, data integrity, or other aspects of the trial and need to be appropriately categorized and reported. You and your team need to be prepared to recognize, document, and respond to every type of protocol event.
3 videos1 reading1 assignment
In this module, you’ll learn about regulatory affairs in clinical trials and how to avoid trial misconduct, which is handled differently from protocol events. Trial investigators are held to federal and local standards in their study conduct, and Institutional Review Boards (IRBs) along with federal agencies are in charge of enforcement. The ramifications for trial investigators engaging in fraud or trial misconduct can result in loss of funding or even legal consequences, so you and your team need to be aware of these expectations and plan for strict compliance throughout your trial.
5 videos1 assignment
In this module, we'll be discussing standardization of research practices, transparency of study activities, and research reproducibility. Standardization improves dissemination of results, easing the possibility of selective reporting between trials and facilitating a complete view of the full body of evidence. Standards for research practice enable study replication, allowing other investigators to duplicate your results for verification purposes. Transparency allows for effective adjudication by journal editors and others who might wish to review your study data. Finally, protocol development and trial registries hold the investigators to the outcomes they pre-specified in their protocol development.
4 videos1 assignment
In this module, you’ll learn about addressing a clinical trial question of interest by synthesizing evidence from various trials. A systematic review focuses on a specific question, and systematic reviewers use explicit, transparent, and replicable scientific methods to identify, select, appraise, and summarize similar but separate studies. Meta-analysis is an optional component of systematic reviews that allows quantitative assessments of outcomes from similar trials.
6 videos1 assignment
In this module, you’ll learn about the standardized study documents used in a clinical trial, including the types of documents and why they’re used. You’ll also learn best practices for creating study documents and the principles for maintaining and managing them.
13 videos1 reading1 assignment
We asked all learners to give feedback on our instructors based on the quality of their teaching style.
Instructor ratings
We asked all learners to give feedback on our instructors based on the quality of their teaching style.
The mission of The Johns Hopkins University is to educate its students and cultivate their capacity for life-long learning, to foster independent and original research, and to bring the benefits of discovery to the world.
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85 reviews
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Reviewed on Jul 23, 2024
This has helped in my studies as well as will be helpful in future
Reviewed on Aug 22, 2023
Team Coursera has arranged a very comprehensive, up-to-date and knowledgeable. Hats off to the team
Reviewed on Apr 23, 2023
Gives good idea of Clinical Trials management and operations.
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