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.
Clinical Trials Management and Advanced Operations
Clinical Trials Management and Advanced Operations
This course is part of Clinical Trials Operations Specialization
Instructors: Ann-Margret Ervin, PhD, MPH
8,594 already enrolled
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Gain insight into a topic and learn the fundamentals.
4.7
(79 reviews)
Beginner level
Recommended experience
4 hours to complete
3 weeks at 1 hour a week
Flexible schedule
Learn at your own pace
What you'll learn
Detect and respond to protocol events
Recognize and respond to misconduct
Safeguard participant safety and trial integrity
Develop and maintain study documents
Skills you'll gain
Details to know
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Assessments
5 assignments
Taught in English
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This course is part of the Clinical Trials Operations Specialization
When you enroll in this course, you'll also be enrolled in this Specialization.
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There are 5 modules in this course
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.
What's included
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.
What's included
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.
What's included
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.
What's included
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.
What's included
13 videos1 reading1 assignment
Instructors
Instructor ratings
4.6 (25 ratings)Offered by
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Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
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RL
5
Reviewed on Jan 18, 2023
Interesting literature with great insight for procedure for compliance with regulatory agencies for clinical trial .
MH
5
Reviewed on Aug 22, 2023
Team Coursera has arranged a very comprehensive, up-to-date and knowledgeable. Hats off to the team
SB
5
Reviewed on Apr 23, 2023
Gives good idea of Clinical Trials management and operations.
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