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[h2]Course Overview[/h2]
The goal of this course is to provide a practical orientation to site management and monitoring of clinical studies. The course provides a comprehensive overview of clinical monitoring in the context of the overall drug development process; FDA and HPB regulations; and ICH guidelines for GCP. The course combines text-based study materials with interactive exercises enabling you to apply what you have learned to on-the-job situations.
You should expect to spend approximately 12 hours of study time to complete the course.
[h3]Course Objectives[/h3]
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- Identify the regulatory basis for monitoring clinical research activities.
- Plan site management and clinical monitoring responsibilities from study initiation to study completion.
- Describe compliance with informed consent procedures.
- Define key steps in maintaining the integrity of trial data.
- Analyze trial-related documents.
- Outline reporting requirements for adverse events.
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[h3]Who Should Attend[/h3]
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- Clinical research associates new to the industry
- Study coordinators
- CRA supervisors
- Pharmacists
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Download Course Outline
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- The US Regulated Environment
- The HPB Regulated Environment
- Informed Consents
- Investigator Selection
- Study Initiation / Investigator Meetings
- Drug Accountability
- Sample Handling
- Site Management / Visits
- Data Management
- Quality Assurance
- What is an Adverse Event (AE)?
- What are the Reporting Requirements of AEs?
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[tab title=”Continuing Education Credit”]
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This course is currently under review for reaccreditation and is not accredited at this time.
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Minimum Hardware Requirements
Windows 98/2000/NT/XP
Mac computer with an Intel processor
Pentium III processor at 500 MHz
128 MB RAM
Minimum Software Requirements
Web browser such as Google Chrome, Internet Explorer 6+, Safari
Adobe Acrobat Reader and Flash plug-ins
Access to the Internet with any connection 56K or above
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PERI, Inc. is the sole owner of the information collected at various points on this site. We will not sell, share, or rent this information to others in ways different from what is disclosed in this statement.
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[h3]Course Details[/h3]
Online Course
4-Month Access
$590 Regular Registration Fee
This course is currently undergoing revision and is unavailable for purchase.
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[h4]Ask a Question[/h4]
Contact one of our course instructors to ask a specific question about the program.
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[h4]Our Students[/h4]
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[dropcap1]1[/dropcap1] “The information in this course will help me in designing clinical trials and dealing with safety monitoring issues.”
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[dropcap2]2[/dropcap2] “Much of the regulatory information will help me in my day-to-day job.”
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