Clinical Trials Management and Advanced Operations
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.
Monthly Subscription Starting at AED 99 + VAT
- Level Foundation
- المدة 5 ساعات hours
- الطبع بواسطة Johns Hopkins University
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Offered by
عن
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.الوحدات
Welcome
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1
Readings
1
Readings
- Welcome to the course!
Protocol Events
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3
Videos
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1
Assignment
1
Assignment
- Protocol Events
3
Videos
- Types of Protocol Events
- Roles and Responsibilities
- Additional Resources
Regulatory Affairs and Trial Misconduct
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5
Videos
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1
Assignment
1
Assignment
- Regulatory Affairs and Trial Misconduct
5
Videos
- Ethical Oversight of Clinical Trials
- Federal Ethical Regulations
- Product-Approval Agencies
- Trial Misconduct
- Additional Resources
Standardization, Transparency, and Research Reproducibility
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4
Videos
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1
Assignment
1
Assignment
- Standardization Transparency and Research Reproducibility
4
Videos
- International Council for Harmonisation
- CONSORT
- SPIRIT and Trial Registration
- Additional Resources
Evidence Synthesis: Introduction to Systematic Reviews and Meta-Analysis
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6
Videos
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1
Assignment
1
Assignment
- Evidence Synthesis
6
Videos
- Systematic Reviews
- Steps in the Systematic Review Process
- Formulating Questions for Systematic Reviews
- Searching for and Selecting Studies
- Data Abstraction and Risk of Bias Assessment
- Data Analysis and Synthesis
Study Documents
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13
Videos
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1
Readings
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1
Assignment
1
Assignment
- Study Documents
13
Videos
- Overview
- Types of Study Document
- Regulatory Study Documents
- Study Documents Related to Design and Implementation
- Participant-Facing Study Documents
- Data-Related Study Documents
- Investigational Product
- Laboratory Information
- Monitoring
- Staffing and Training
- Close-Out
- Other Documentation
- Closing
1
Readings
- Closing Thoughts
Auto Summary
Enhance your expertise in clinical trials management with this comprehensive course on advanced operations in the Health & Fitness domain. Guided by Coursera, you'll master the skills to manage protocol events, conduct systematic reviews, handle adverse events, and comply with regulations. This 300-hour foundational course offers flexible subscription options, including Starter and Professional plans, making it ideal for health professionals seeking to elevate their clinical trial practices.
Ann-Margret Ervin, PhD, MPH
Anne Shanklin Casper, MA
Sheriza Baksh, PhD