Course 2: Clinical Safety Surveillance
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With interactive content and engaging, real-world case study exercises, this course covers what you need to know from a clinical trial sponsor perspective regarding the requirements and practice of safety data collection, assessment, and reporting of serious adverse events (SAEs) reports during clinical development. The course will help you understand the FDA and EU regulations and related ICH guidance documents pertaining to safety surveillance activities of an investigational product, or marketed product being investigated for a new indication, different formulation or new dose, as it moves through the various stages of clinical studies until licensed for marketing.
This course will help you develop a clear working vocabulary of safety terminology, definitions, and knowledge of the specific US and EU regulations and guidance documents relevant to clinical safety surveillance of investigational drug and biologic products.
This course helps you to understand the similarities and differences in US and EU regulations of safety reporting requirements during clinical trials. This course also provides a step-by-step overview of the Sponsor’s safety operations workflow, from receipt of SAE reports from investigators, through individual case safety report (ICSR) processing, causality and reportability assessment, and reporting to regulatory authorities, investigators, and Institutional Review Boards (IRBs) and Ethics Committees.
What will I learn?
After completing this course, you will be able to:
- Describe the purpose of safety surveillance in clinical trials
- Explain the general regulatory oversight of clinical trials in the US and EU
- List the key stakeholders in a clinical trial and explain their role in assuring the safety of study subjects
- Differentiate between US and EU regulations and guidances, and explain the influence of ICH and CIOMS
- Define key terms and concepts central to clinical safety surveillance (e.g., serious, expected, relatedness, dechallenge, rechallenge)
- Describe the purpose and content of Investigator’s brochure and the expected AE list
- List the responsibilities of the clinical trial investigator in AE reporting
- Understand the data fields collected for AEs and SAEs on reporting forms
- Identify the key steps in the workflow for processing an SAE report
- Describe in what situations a 7- and/or 15-day expedited safety report is required
- Determine how to triage SAE reports, and determine if an SAE report meets expedited regulatory reporting requirements
- Learn the important components of an SAE case narrative
- Demonstrate how and when to write a query to request follow-up information
- Describe when it is appropriate to unblind treatment assignment for SAE reports
- Understand the difference between the clinical and safety databases, and the purpose of database reconciliation
- Explain what is required for submitting reports to US and EU regulatory authorities and investigators
- Explain how overdose and pregnancy are typically reported in clinical trials
How long will it take to complete the course?
The course takes the average learner approximately 4 hours to complete. Note, you do not have to complete the course in one sitting. BioSoteria’s Learning Management System bookmarks and tracks your progress, allowing you to pace yourself through the material over time and repeat sections as often as you like.
Who should consider the course?
Course 2 is appropriate for professionals entering or already in the pharmaceutical, biotechnology, and medical device industry in the areas of nonclinical research, clinical research, drug safety and pharmacovigilance, project management, regulatory affairs, medical information or medical affairs, quality assurance/compliance. Course 2 is also appropriate for professionals in academic centers, healthcare practice settings, or in government organizations who are involved in drug, biologic, or medical device development.
Ready to register your drug safety department?
If you are interested in purchasing Course 2 or any course from the eLadder™ Safety eLearning Program for more than one user, multi-user licensing at a discount is available. Contact us today to discuss the options available to you or your organization by emailing .(JavaScript must be enabled to view this email address), or call +1 (866) 660 5553 ext. 13 (outside the US, please dial +1 650 616 4151, extension 13).
Who developed the content for this course?
To guide content development, BioSoteria’s eLearning team carefully selects a Course Faculty of subject-matter experts who are currently practicing in the field of drug safety. This ensures that the content is accurate, current, and reflects the everyday realities of drug safety practitioners. Faculty members are integrally involved in reviewing course outlines, storyboards, and the course itself. Faculty members provide input into all facets of the course, including the content, graphics, and overall learning intent.
