Documenti di Didattica
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Disclaimer and
Copyright Notice
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Course Overview
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MedDRA Overview
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MedDRA Definition
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Scope of MedDRA
OUT
Not a drug Frequency
IN
dictionary qualifiers
Medical conditions
Indications
Investigations (tests, results)
Patient demographic Numerical values for
Medical and surgical procedures
terms results
Medical, social, family history
Medication errors
Product quality issues
Device-related issues
Product use issues
Clinical trial study Severity descriptors
Pharmacogenetic terms
design terms Toxicologic issues
Standardized queries
Not an equipment, device,
diagnostic product dictionary
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MedDRA Structure
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PT = Arrhythmia
LLT LLT
Arrhythmia LLT Dysrhythmias
NOS Arrhythmia LLT (Non-current)
Other specified cardiac
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dysrhythmias Not all LLTs shown
Non-Current Terms
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A Multi-Axial Terminology
• Multi-axial = the representation of a medical
concept in multiple SOCs
– Allows grouping by different classifications
– Allows retrieval and presentation via different data set s
• All PTs assigned a primary SOC
– Determines which SOC will represent a PT during
cumulative data outputs
– Prevents “double counting”
– Supports standardized data presentation
– Pre-defined allocations should not be changed by users
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A Multi-Axial Terminology
(cont)
SOC = Respiratory, thoracic and SOC = Infections and
mediastinal disorders infestations
(Secondary SOC) (Primary SOC)
PT = Influenza
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A Multi-Axial Terminology
(cont)
PTs in the following SOCs only appear in that
particular SOC and not in others, i.e., they
are not multi-axial
• Investigations
• Surgical and medical procedures
• Social circumstances
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What are
Coding Conventions?
• Written guidelines for coding with MedDRA in your
organization
• Support accuracy and consistency
• Common topics
– Misspellings, abbreviations and acronyms
– Combination terms and “due to” concepts
– “Always query” terms, e.g., “Chest pain”
• Should be consistent with the MedDRA Term
Selection: Points to Consider document
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PtC Documents
PtC Category PtC Document Purpose Languages Release Cycle
Term Selection MedDRA Term Promote accurate and English, Japanese, and other Updated annually
Selection: Points to consistent coding with selected languages with the March
Consider MedDRA release of MedDRA
(starting with
MedDRA Version
23.0)
MedDRA Term Shorter version focusing on All MedDRA languages Update as needed
Selection: Points to general coding principles to (except English, Japanese,
Consider promote accurate and and other languages with an
Condensed Version consistent use of MedDRA available translation of the
worldwide full MTS:PTC document)
Data Retrieval MedDRA Data Demonstrate how data English, Japanese, and other Updated annually
and Retrieval and retrieval options impact the selected languages with the March
Presentation Presentation: Points accuracy and consistency release of MedDRA
to Consider of data output (starting with
MedDRA Version
23.0)
MedDRA Data Shorter version focusing on All MedDRA languages Update as needed
Retrieval and general retrieval and (except English, Japanese,
Presentation: Points analysis principles to and other languages with an
to Consider promote accurate and available translation of the
Condensed Version consistent use of MedDRA full DRP:PTC document)
worldwide
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Abdominal pain
Lipase increased
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Autoencoder Pitfalls
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MSSO’s MedDRA
Browsers
• MedDRA Desktop Browser (MDB)
– Download MDB and release files from MedDRA website
• MedDRA Web-Based Browser (WBB)
– https://tools.meddra.org/wbb/
• Mobile MedDRA Browser (MMB)
– https://mmb.meddra.org
• Features
– Each require MedDRA ID and password
– View/search MedDRA and SMQs
– Support for all MedDRA languages
– Language specific interface
– Ability to export search results and Research Bin to local file
system (MDB and WBB only)
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– Is it a combination of these?
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Coding Example 1
Specificity
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Coding Example 2
Symptoms
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Coding Example 3
Investigations
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Coding Example 4
Medication errors
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Coding Example 5
Patient demographics
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Coding Example 6
Indications
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Coding Example 7
Specificity
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Coding Example 8
Specificity
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Coding Example 9
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Coding Example 10
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Coding Example 11
Social circumstances
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Coding Example 12
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Coding Example 13
Narrative vignette
A 75-year-old male receiving Drug X for
rheumatoid arthritis developed symptomatic
aortic valve stenosis. The patient’s medical
history is significant for colon cancer and
cigarette smoking. He underwent an aortic valve
replacement and developed a sternal wound
infection three days post-surgery.
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Summary
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MSSO Contacts
• Website
– www.meddra.org
• Email
– mssohelp@meddra.org
• Frequently Asked Questions
– www.meddra.org/faq
• MedDRA Browsers
– https://www.meddra.org/meddra-desktop-browsers
(Desktop Browser)
– https://tools.meddra.org/wbb/ (Web-Based Browser)
– https://mmb.meddra.org (Mobile Browser)
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