Johns Hopkins University
Clinical Trials Management and Advanced Operations
Johns Hopkins University

Clinical Trials Management and Advanced Operations

This course is part of Clinical Trials Operations Specialization

Taught in English

Some content may not be translated

Ann-Margret Ervin, PhD, MPH
Anne Shanklin Casper, MA
Sheriza Baksh, PhD

Instructors: Ann-Margret Ervin, PhD, MPH

6,310 already enrolled

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Course

Gain insight into a topic and learn the fundamentals

4.9

(54 reviews)

Beginner level

Recommended experience

4 hours (approximately)
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

Details to know

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Assessments

5 quizzes

Course

Gain insight into a topic and learn the fundamentals

4.9

(54 reviews)

Beginner level

Recommended experience

4 hours (approximately)
Flexible schedule
Learn at your own pace

See how employees at top companies are mastering in-demand skills

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Build your subject-matter expertise

This course is part of the Clinical Trials Operations Specialization
When you enroll in this course, you'll also be enrolled in this Specialization.
  • Learn new concepts from industry experts
  • Gain a foundational understanding of a subject or tool
  • Develop job-relevant skills with hands-on projects
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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 quiz

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 quiz

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 quiz

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 quiz

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 quiz

Instructors

Instructor ratings
4.7 (20 ratings)
Ann-Margret Ervin, PhD, MPH
Johns Hopkins University
3 Courses18,474 learners
Anne Shanklin Casper, MA
Johns Hopkins University
1 Course6,310 learners

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4.9

54 reviews

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5

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Reviewed on Apr 23, 2023

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