Articoli correlati a From Verbatim to Signal: MedDRA Coding, SMQs, and Safety...
Sinossi
Every safety conclusion rests on a chain of small coding and search decisions. This book shows you how to get each one right.
A nurse writes “yellow eyes” in a telephone note. A case processor picks a Lowest Level Term. A reviewer accepts it. Months later, a scientist runs a search, a programmer counts what it returns, and a safety team decides whether there is a signal. If one link in that chain is careless, the table is wrong in a way no statistical method can repair.
From Verbatim to Signal follows safety information from the reporter’s own words through MedDRA coding, SMQ and customized retrieval, medical review and aggregate surveillance to a justified recommendation. At every step it asks one practical question: how does this coding or search decision change what the safety team can find and conclude?
What you will learn
- How the MedDRA hierarchy works, and when to search at LLT, PT, HLT, HLGT, SOC or SMQ level
- Term selection for diagnoses, symptoms, laboratory findings, medication errors and other special situations
- Narrow, broad, hierarchical and algorithmic SMQ searches, their limits, and when a customized query is the better tool
- Counting rules, search performance and how to defend a retrieval strategy
- Surveillance planning for clinical trials and the postmarketing setting, signal detection and assessment, and how to communicate findings
- Version control, reproducible surveillance, automated and AI-assisted coding, and team governance
Built for practice
- 22 chapters in five parts, each with worked cases, common errors and an exercise
- One fictional medicine, Product A, runs through the whole book, from a single telephone report in Chapter 1 to a capstone assessment in Chapter 22
- Solved examples, visual aids, and role tips for safety scientists, safety physicians and safety leaders
- Reusable worksheets, a glossary and hierarchy reference, answers to every part exercise, and a free online companion workbench with a coding trainer, retrieval lab and surveillance calculators
Written against MedDRA Version 29.0 (March 2026) and the current MedDRA Points to Consider documents, with a version statement and update log so you know exactly what each example reflects.
Who it is for: case processors and coders, safety scientists, safety physicians, clinical development and data-management teams, and anyone who designs, runs or reviews MedDRA-based searches and safety outputs.
About the author: Dr. Hafez Selim, MD, PhD, is a physician-scientist and safety physician at a top-ten global pharmaceutical company, with nearly a decade of prior safety leadership at a leading global medical device company and regulatory experience across FDA, EMA, MHRA and PMDA.
This is an independent teaching text. It is not published, endorsed or reviewed by ICH, the MSSO or the JMO. MedDRA® is a registered trademark of ICH. All cases and data are synthetic.
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From Verbatim to Signal : MedDRA Coding, SMQs, and Safety Surveillance
Da: AHA-BUCH GmbH, Einbeck, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. Neuware. Codice articolo 9798161601556
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EUR 62,94
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Spedito da Germania a U.S.A.
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