Assessing Adverse Event Causality: A Guide for Investigators and Sites
You’re in the middle of an “uh oh” moment: a patient in your clinical trial has an adverse health event. Can you easily determine if the investigational product (IP) is the cause? Do you know what information your IRB and sponsor want to see? Or what the FDA requires?
Assessing Adverse Event Causality: A Guide for Investigators and Sites answers all your questions and shows you how to proceed.
While the FDA and other regulators acknowledge that the investigator is best suited to determine whether or not the event was caused by the IP, they offer little guidance on such a critical matter.
Enter Assessing Adverse Event Causality. It walks you through a nine-step process for evaluating adverse events (based on the Bradford Hill Criteria for Causality model), explains what information to collect, what questions to ask and how to analyze the answers. You’ll come to a yes-no, related-nonrelated conclusion that can be reported to your IRB and sponsor.
It also explains what the FDA and other regulators expect in those reports. You will understand the terms and concepts that should — and those that should not — be used. And you’ll see all of the concepts illustrated clearly through case studies.
Management report takeaways:
- How to apply the nine principles of causality: strength of association, consistency, temporality, specificity, biological gradient, plausibility, coherence, experiment and analogy
- What sources of information can help in analyzing the event (e.g., preclinical information, medical literature, Investigator’s Brochure)
- Which aspects of a patient’s history should be examined
- How to apply the dechallenge/rechallenge test
- Whether the terms “probable” and “possible” should be used
Patient safety and trial success will be yours when you make critical decisions about adverse events with ease. Get there with Assessing Adverse Event Causality: A Guide for Investigators and Sites.
About the Contributors
Gerald Klein, MD, principal, MedSurgPI, is a former professor of clinical medicine and pediatrics at the University of California, Irvine.
Jamison Chang, MD, medical officer at Rho, is a board-certified internist with more than 15 years of clinical experience. He has additional training in nephrology and a master’s degree in clinical research.
Who Will Benefit
- Principal investigators (PIs)
- Clinical research coordinators (CRCs)
- Clinical research associates (CRAs)
- Medical officers
- Science officers
- Compliance/regulatory officers
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Gerald Klein and Jamison Chang
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