MedDRA® Training – Eisai Inc. February 2007

MedDRA® Training – Eisai Inc. February 2007
MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Course Objectives/Overview
To provide an introduction to: MedDRA’s structure, scope, and characteristics Coding and the “MedDRA Term Selection: Points to Consider” document Data quality issues MedDRA’s application in data retrieval and analysis: the “MedDRA Data Retrieval and Presentation: Points to Consider” document Standardised MedDRA Queries (SMQs)

MedDRA Background

What is MedDRA? Med = Medical D = Dictionary for R = Regulatory
A = Activities

Conditions Before MedDRA
Use of different types of terminologies Use of terminologies for different phases of regulatory cycle Lack of specificity of terms Limited data retrieval options Resulting use of non-standard terminologies developed “in-house” Resulting high cost and time investment

Objectives for MedDRA Development
To provide: An international multi-lingual terminology Standardized communication between industry and regulators Support of electronic submissions Application through all phases of the development cycle

Objectives for MedDRA Development (cont)
To provide (cont): Classification for a wide range of clinical information Support for multiple medical product areas A terminology that saves time, resources, and money

MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. e.g. in full regulatory process: Clinical studies - Reports of spontaneous adverse reactions and events - Regulatory submissions - Regulated product information

MedDRA’s Structure and Scope

Scope of MedDRA OUT IN Population-level qualifiers Drug product terms
Diseases Diagnoses Signs Symptoms Therapeutic indications Investigation names & qualitative results Medical & surgical procedures Medical, social, family history Numerical values for results Patient demographic terms Terms from: COSTART© WHO-ART© HARTS© J-ART© Severity descriptors Clinical trial study design terms Equipment, device, diagnostic product terms

MedDRA Structure System Organ Class (SOC) (26)
High Level Group Term (HLGT) (332) High Level Term (HLT) (1,682) Preferred Term (PT) (17,505) Lowest Level Term (LLT) (64,620)

MedDRA Term Level Definitions
SOC - Highest level of the terminology, and distinguished by anatomical or physiological system, etiology, or purpose HLGT - Subordinate to SOC, superordinate descriptor for one or more HLTs HLT - Subordinate to HLGT, superordinate descriptor for one or more PTs PT - Represents a single medical concept LLT - Lowest level of the terminology, related to a single PT as a synonym, lexical variant, or quasi-synonym (Note: All PTs have an identical LLT)

System Organ Classes Blood and lymphatic system disorders
Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social circumstances Surgical and medical procedures Vascular disorders

MedDRA Codes Each MedDRA term assigned an 8-digit numeric code
The code is non-expressive Codes can fulfill a data field in various electronic submission types (e.g., E2b) Initially assigned alphabetically by term starting with New terms are assigned sequentially Supplemental terms are assigned codes

Non-Current Terms Non-current terms are flagged at the LLT level within MedDRA Not recommended for continued use Retained within the terminology to preserve historical data for retrieval and analysis Terms very vague, ambiguous, out-dated, truncated, or misspelled Terms derived from other terminologies that do not fit MedDRA rules

Examples of LLTs SOC = Cardiac disorders HLGT = Cardiac arrhythmias
HLT = Rate and rhythm disorders NEC PT = Arrhythmia LLT Dysrhythmias LLT Arrhythmia NOS LLT Arrhythmia LLT Cardiac arrhythmia

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 sets Purpose of Primary SOC Determines which SOC will represent a PT during cumulative data outputs Is used to support consistent data presentation for reporting to regulators

A Multi-Axial Terminology (cont)
A PT can be associated with one or more SOCs One of the associations is primary; all others are secondary A PT will have one and only one path to any particular SOC MedDRA can express multi-axiality at the PT, HLT, or HLGT level

SOC = Respiratory, thoracic and mediastinal disorders SOC = Infections and infestations HLGT = Respiratory tract infections HLGT = Viral infectious disorders HLT = Viral upper respiratory tract infections HLT = Influenza viral infections PT = Influenza

SOC = Nervous system disorders SOC =Skin and subcutaneous tissue disorders HLGT = Neurological disorders NEC HLGT = Epidermal and dermal conditions HLT = Paraesthesias and dysaesthesias HLT = Dermal and epidermal conditions NEC PT = Hypoaesthesia facial

Rules for Primary SOC Allocation
PTs for diseases, signs and symptoms are assigned to prime manifestation site SOC Congenital and hereditary anomalies terms have SOC Congenital, familial and genetic disorders as Primary SOC Neoplasms terms have SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) as Primary SOC Exception: Cysts and polyps have prime manifestation site SOC as Primary SOC Infections and infestations terms have SOC Infections and infestations as Primary SOC

Rules for Primary SOC Allocation (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

Browser Demonstration

MedDRA Maintenance

MedDRA Maintenance MedDRA is a user responsive terminology which means that if inadequacies exist in MedDRA, you may submit change requests to the MSSO for consideration. Per core subscriber: 100 simple change requests per month Changes at the PT level and below in the MedDRA terminology structure Routine: Notified of supplemental change within 7-14 days Weekly supplemental changes 9,000 possible simple changes per year, all subscribers combined Complex changes above PT level once a year

MedDRA Maintenance (cont)
Twice yearly official updates 1 September X.1 release (Simple changes only) 1 March X.0 release (Complex changes) Current version 9.1 Next version 10.0 in March 2007

Summary of Requests for Version 9.1 Release
Change requests: Processed Approved Rejected Suspended

Regulatory Considerations

Regulatory Status of Mandate
US FDA MedDRA used in FDA’s internal adverse event database (AERS) since 1997 Proposed Rule for Safety Reporting Requirements (2003): FDA proposes to use MedDRA for postmarketing safety reports Japanese Ministry of Health, Labour and Welfare Electronic reports mandatory from October 2003 MedDRA to be used in Periodic Infection and Safety Reports April 2004

Regulatory Status of Mandate (cont)
European Union Mandatory for all adverse drug reaction reporting since January 2003 Clinical trial SUSARs (Suspected Unexpected Serious Adverse Reactions) and post-authorization Individual Case Safety Reports (ICSRs) reported to EudraVigilance database require MedDRA (LLT codes, current, or previous version) Summary of Product Characteristics Guideline (October 2005): MedDRA to be used in Undesirable Effects section ICH M4E Guideline on Common Technical Document MedDRA recommended in adverse event summary tables

Versioning Practices at Eisai
Safety Department Use current version of MedDRA, driven by EMEA reporting requirements MedDRA updated to new version within 60 days of release

Versioning Practices at Eisai (cont)
Eisai Global Clinical (EGC) Use current version of MedDRA, driven by EMEA reporting requirements MedDRA updated to new version within 60 days of release Coding done with current version as data received; re-coded to current version at end of trial Data in Integrated Safety Summary re-coded from AE verbatim terms to current version Practices are consistent with the MSSO’s “Recommendations for MedDRA Implementation and Versioning for Clinical Trials” (

Coding with MedDRA

What Is “Coding”? Code 1 : a systematic statement of a body of law; especially one given statutory force 2 : a system of principles or rules <moral code> 3 a : a system of signals or symbols for communication b : a system of symbols (as letters or numbers) used to represent assigned and often secret meanings 4 : genetic code 5 : a set of instructions for a computer

Why Do We Code? Retrieve Present Analyze Communicate

What Does MedDRA Offer? Size and specificity (“granularity”)
Hierarchy/grouping terms “Support” SOCs widen data collection/analysis options Up-to-date and medically rigorous User-responsive STANDARDIZATION

Overview of “MedDRA Term Selection: Points to Consider” Document

“MedDRA Term Selection: Points to Consider”
An ICH-endorsed guide for MedDRA users A “companion document” to MedDRA Applies to adverse events/reactions, medical and social history, and indications Developed to promote medically accurate and consistent use of MedDRA in exchange of data (ultimately, for “medically meaningful” retrieval and analysis)

“Points to Consider” Term Selection Document (cont)
Developed by a working group of the ICH Steering Committee Regulators and industry representatives EU, Japan, USA Canadian observer, MSSO, JMO Current version available on MedDRA MSSO website

Document addresses: Quality of source data Level of term selected Use of “Current”/”Non-current” Lowest Level Terms (LLTs) Choice of term “Do not subtract or add information” Quality assurance Human oversight of automated coding results Qualification of coder/review staff Errors in MedDRA should be addressed by submissions of Change Requests to MSSO; no ad hoc structural alterations to MedDRA

Obtain clarification of data that are confusing, ambiguous, or unintelligible Can be optimized by careful design of data collection forms and proper training of relevant staff When left with data that cannot be clarified, refer to section 3.3 REMEMBER: No terminology (including MedDRA) will help in understanding data that is of poor quality; best to get good information at the beginning

Level of term selection Lowest level term(s) that “most accurately reflects the reporter’s words ” should be selected Example: “Mouth sore”  select “Sore mouth” (PT “Oral pain”) Example: “Sores in mouth”  select “Sores mouth” (PT “Stomatitis”)

Level of term selection (cont) Lowest level term(s) that “most accurately reflects the reporter’s words ” should be selected Example: “Phlebitis right arm”  select “Phlebitis arm” (PT “Phlebitis”, SOC “Vascular disorders”) Example: “Phlebitis right arm injection site”  select “Phlebitis injection site” (PT “Injection site phlebitis”, SOC “General disorders and administration site conditions”)

Currency and choice of term Select current LLTs only If no exact LLT match for verbatim term, use medical judgment to match to an existing MedDRA term that adequately represents the concept

“Points to Consider” Term Selection Document “Do not subtract or add information”
Do not make a diagnosis if only signs/symptoms are reported Example: “Abdominal pain” + “Increased serum amylase” + “Increased serum lipase”  inappropriate to select “Pancreatitis” If have both signs/symptoms and diagnosis, may code both or just diagnosis Example: “Anaphylactic reaction” also reported with “rash, dyspnea, hypotension and laryngospasm”  “Anaphylactic reaction” and “Rash,” “Dyspnea,” “Hypotension,” and “Laryngospasm” can be selected OR, only “Anaphylactic reaction” can be selected

“Points to Consider” Document Term Selection Points
Term Selection Points addressed: Provisional diagnoses Death and other patient outcomes Conflicting/ambiguous/vague information Combination terms Body site vs. Event specificity Location vs. Infectious agent Pre-existing medical conditions Congenital terms Medical/surgical procedures

“Points to Consider” Document Term Selection Points (cont)
Term Selection Points addressed (cont): Investigations Medication/administration errors and accidental exposures Overdose/Toxicity/Poisonings Drug interactions No adverse effect Unexpected therapeutic effect Modification of effect Use of SOC Social circumstances Medical and/or social history Indication for product use

Conflicting information: e.g., if “Hyperkalemia with a serum potassium of 1.6 mEq/L”  “Serum potassium abnormal” can be selected Ambiguous information: e.g., “GU pain”  “Pain” can be selected (“GU” could be “genito-urinary” or “gastric ulcer”) Vague information: e.g., “Patient experienced every listed adverse event”  “Unevaluable event” can be selected

Combination terms If one term is more specific than the other(s), the most specific term should be selected. E.g., “Arrhythmia due to atrial fibrillation”  “Atrial fibrillation” can be selected If a MedDRA term exists that adequately describes the combination, that term should be used. E.g., “Retinopathy due to diabetes”  “Diabetic retinopathy” can be selected

Combination terms (cont) If “splitting” provides more information, it is appropriate to select more than one term. “DIC due to sepsis”  “DIC” and “Sepsis” can be selected “Wrist fracture due to fall”  “Wrist fracture” and “Fall” can be selected In all cases of combination terms, apply medical judgment

Investigations Medical condition vs. laboratory result “Hypoglycemia”  “Hypoglycemia” (PT “Hypoglycaemia”, SOC “Metabolism and nutrition disorders”) can be selected “Decreased glucose”  “Glucose decreased” (PT “Blood glucose decreased”, SOC “Investigations”) can be selected

Investigations Medical condition vs. laboratory result (cont) “Fever”  “Fever” (PT “Pyrexia”, SOC “General disorders and administration site conditions”) can be selected “Temperature increased”  “Body temperature increased” (PT “Body temperature increased”, SOC “Investigations”) can be selected

CTCAE and MedDRA National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology used for AE reporting in oncology and HIV clinical trials Need to convert CTCAE terms to MedDRA terms in clinical trial databases for purposes of analysis and reporting Blue Ribbon Panel Meeting (BRP) on CTCAE to MedDRA Mapping held on 6 April 2006 (

CTCAE and MedDRA (cont)
BRP Recommendations A standardized mapping of grades is important for consistency A guidance document for consistent use is also needed The stakeholders involved (industry, regulators, cooperative groups, CTEP, MSSO and others) should begin a dialogue to address the optimal use of both terminologies A collaborative working group should be formed Optimal data collection practices and conventions could also be addressed If needed, both terminologies could be modified to achieve harmonization and create an optimal mapping Provide guidance for dealing with legacy data

BRP recommendation to map CTCAE laboratory terms consistently to MedDRA investigation terms E.g., CTCAE Term “Potassium, serum low (hypokalemia)” to LLT Serum potassium decreased (not LLT Hypokalemia) E.g., CTCAE Term “Neutrophils/granulocytes (ANC/AGC) to LLT Neutrophil count decreased CTCAE v3.0 to MedDRA Version 9.0 mapping is on MSSO Web site (laboratory term and grade mapping issues not addressed) CTCAE v3.0 to MedDRA Version 10.0 mapping to be posted in March 2007 (laboratory term mapping issue addressed)

Eisai encourages sites to report the exact medical condition as the AE Monitors should ensure that stand alone AE term describes event When CTCAE laboratory term plus grade is reported, site is queried to provide actual diagnosis E.g., Reported term “Neutrophils low” with “CTCAE Grade 3” will be queried to change to diagnosis term “Neutropenia” “Neutropenia”  “Neutropenia” (PT “Neutropenia”, SOC “Blood and lymphatic system disorders”) “Neutrophils low”  “Neutrophil count low” (PT “Neutrophil count decreased”, SOC “Investigations”)

Data Quality

Importance of Good Quality Data
Quality of initial data has a direct impact on quality of data output: Recording and coding Retrieval and analysis

QA Reports Allows reviewers to check for consistency (both autoencoded and human-coded terms) Check for adherence to/deviation from coding conventions Check for emerging drifts/biases Multiple data views (verbatim terms to coded terms; coded term to verbatims; by SOC, etc.)

Data Quality, Coding, and MedDRA Training Module
Target audience: Investigators, study coordinators, company, and CRO personnel Content includes: Clinical trial regulations, emphasis on safety MedDRA overview Coding examples - do’s and don’t’s for reporting data Space for company’s own conventions

Data Quality, Coding, and MedDRA Training Module (cont)
>600 unique downloads since February 2005 (MSSO Web site -free to subscribers) Applications: Customized by company and used at investigators’ meetings and internal web-based training Data do’s and don’t’s on laminated card as a reminder for coordinators and CRAs

What were they thinking? (Actual verbatim terms)
Went to hell Recurrent fatal stroke Hears New Age music when the furnace turns on LK RTCTL UNSP XTRNDL Charcoal-like, gritty granules in his underwear Can’t control patient during menses His nodule is sticking out Normally normal after drinking coffee Died of cancer of the placebo Superior members fornication Barely visible posterior Seeing people in room, seeing chickens at window Seeing stars and chicken farting Patient recently began new job where he works around chicken wings and barbecue sauce

Overview of “MedDRA Data Retrieval and Presentation: Points to Consider” Document

MedDRA Data Retrieval and Presentation: Points to Consider
An ICH-Endorsed Guide for MedDRA users on Data Output Developed by an ICH Expert Working Group Provides data retrieval and presentation options for industry or regulatory purposes Objective is to promote understanding of implications that various options for data retrieval have on accuracy and consistency of final output Current version available on MedDRA MSSO Web site (

Data Retrieval PTC Points Addressed
Quality of Source Data Quality Assurance Organization-Specific Data Characteristics Impact of MedDRA’s Characteristics on Data Retrieval and Presentation Grouping terms Granularity Multi-axiality Special Search Categories Standardised MedDRA Queries MedDRA Versioning Queries and Retrieval Examples

Data Retrieval PTC Quality of Source Data
High quality data output is dependent on maintaining quality of original information reported by using consistent and appropriate term selection (Refer to “MedDRA Term Selection: Points to Consider” document) Method of conversion of data into MedDRA might impact retrieval and presentation - legacy data conversion using verbatims or coded terms

Data Retrieval PTC Quality Assurance
Documentation of coding conventions, data retrieval and presentation strategies, methods and QA procedures in organization-specific guidelines Review by individuals with medical background and MedDRA training Errors in MedDRA should be addressed by submissions of Change Requests to MSSO; no ad hoc structural alterations to MedDRA

Data Retrieval PTC Impact of MedDRA’s Characteristics – Grouping Terms
HLGTs and HLTs provide clinically relevant groupings HLGT Cardiac arrhythmias HLT Cardiac conduction disorders HLT Rate and rhythm disorders NEC HLT Supraventricular arrhythmias HLT Ventricular arrhythmias and cardiac arrest

Data Retrieval PTC Impact of MedDRA’s Characteristics – Grouping Terms
Caution - ensure all terms are relevant to output HLT Vascular tests NEC (incl blood pressure) PT Blood pressure decreased PT Blood pressure increased Caution - related PTs in different locations in SOC HLT Bullous conditions PT Stevens-Johnson syndrome HLT Exfoliative conditions PT Dermatitis exfoliative

Data Retrieval PTC - Granularity
Frequency and Incidence: COSTART vs. MedDRA COSTART Preferred Terms # of Subj MedDRA Version 9.1 Preferred Terms #of Subj INFECTION 12 Upper respiratory tract infection Nasopharyngitis Localised infection Lower respiratory tract infection Nonspecific reaction 7 2 1 ABDOMINAL PAIN 9 Abdominal pain upper Abdominal pain Abdominal tenderness 3 4 ACCIDENTAL INJURY Injury Skin laceration Joint sprain Back injury

Data Retrieval PTC Multi-Axiality
Primary SOC allocation rules affect the way data are distributed across the terminology Impact on frequencies of medical condition of interest should be considered Example: for hepatic abnormality search in SOC Hepatobiliary disorders, SOC Investigations (laboratory test terms), SOC Surgical and medical procedures (e.g. PT Liver transplant)

Data Retrieval PTC Multi-Axiality (cont)
Main presentation is by Primary SOC Secondary SOCs used for alternate views and presentation of data

Primary SOC Analysis – SOC Infections and infestations
Adverse Event (MedDRA 9.1) 25 mg MyDrug (N=44) Placebo (N=15) SOC Infections and infestations 14 (31.8%) 4 (26.7%) PT Upper respiratory tract infection 5 (11.4%) 2 (13.3%) PT Sinusitis 3 (6.8%) PT Urinary tract infection 2 (4.5%) 1 (6.7%) PT Ear infection PT Viral infection PT Bronchitis acute 1 (2.3%) PT Influenza PT Localised infection PT Lower respiratory tract infection PT Pneumonia PT Tooth abscess Patients may have more than one event reported

Secondary SOC Analysis – SOC Infections and infestations
Adverse Event (MedDRA 9.1) 25 mg MyDrug (N=44) Placebo (N=15) SOC Respiratory, thoracic and mediastinal disorders PT Upper respiratory tract infection 5 (11.4%) 2 (13.3%) PT Sinusitis 3 (6.8%) PT Bronchitis acute 1 (2.3%) PT Influenza PT Lower respiratory tract infection PT Pneumonia SOC Infections and infestations PT Viral infection 2 (4.5%) PT Localised infection 1 (6.7%) Patients may have more than one event reported

Secondary SOC Analysis – SOC Infections and infestations (cont)
Adverse Event (MedDRA 9.1) 25 mg MyDrug (N=44) Placebo (N=15) SOC Renal and urinary disorders PT Urinary tract infection 2 (4.5%) 1 (6.7%) SOC Ear and labyrinth disorders PT Ear infection SOC Gastrointestinal disorders PT Tooth abscess 1 (2.3%) Patients may have more than one event reported

Data Retrieval PTC MedDRA Versioning
MedDRA is updated twice a year Version used in data retrieval and presentation should be documented Terms used for queries should be in same version as data being queried

Data Retrieval PTC MedDRA Versioning (cont)
Number of Events at PT Level Coronary artery surgery (PT) 15 MedDRA Version 9.1 Coronary artery surgery (no longer a PT) Coronary artery bypass (newly added PT)

Data Retrieval PTC Queries and Retrieval Summary
General Principles Data retrieval is performed for analysis of clinical trial data, pharmacovigilance, etc. Strategies, methods and tools used depend on intended use of output Update previously used searches Identify safety issues prior to retrieval - information from pre-clinical & clinical trials, postmarketing surveillance, similar products, regulatory queries Group related events Evaluate search results against original question

Data Retrieval PTC Queries and Retrieval Summary (cont)
Examples of searches Overview of safety profile in summary reports Comparison of frequency of ADR/AE (spontaneous reports or incidence for studies) Analysis of a specific safety concern Identification of patient subpopulations at risk (e.g. searching medical history information)

Data Retrieval PTC Queries and Retrieval Examples
Overall presentation of Safety Profiles Highlight overall distribution of ADRs/AEs Identify areas for in-depth analysis (focused searches)

Data Retrieval PTC Queries and Retrieval Examples (cont)
Overview by Primary SOC Internationally Agreed Order of SOCs (see PTC or MedDRA Introductory Guide) Consider use of HLTs and HLGTs for large data sets Line listings, tables, graphical displays

Data Retrieval PTC Queries and Retrieval Examples (cont)
Focused searches: Secondary SOC assignments Standardised MedDRA Queries (SMQs) Ad hoc queries Organization-specific or project-specific queries Send Change Request to MSSO for consideration for SMQ development? Store for future use and update

Introduction to Standardised MedDRA Queries (SMQs)

Definition of SMQ Result of cooperative effort between CIOMS and ICH (MSSO) Groupings of terms from one or more MedDRA System Organ Classes (SOCs) related to defined medical condition or area of interest Included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., related to medical condition or area of interest Intended to aid in case identification

SMQs As of Version 9.1, a total of 28 in production (Many other SMQs in development) Acute pancreatitis Acute renal failure Agranulocytosis Anaphylactic reaction Angioedema Anticholinergic syndrome Asthma/bronchospasm Cardiac arrhythmias (includes Torsade de pointes) Cerebrovascular disorders Depression and suicide/self-injury Dyslipidaemia Haematopoietic cytopenias Haemolytic disorders Haemorrhages Hepatic disorders Hyperglycaemia/new onset diabetes mellitus

SMQs (cont) SMQs (28) in production (cont) Interstitial lung disease
Ischaemic heart disease Lack of efficacy/effect Lactic acidosis Neuroleptic malignant syndrome Peripheral neuropathy Rhabdomyolysis/myopathy Retroperitoneal fibrosis Severe cutaneous adverse reactions Shock Systemic lupus erythematosus Taste and smell disorders

SMQ Resources Refer to MSSO Web site for current status of SMQs in production and development

SMQs as a Starting Point
Standard query as starting point promotes commonality of use and better communication In limited circumstances, SMQs could be customized according to product and patient population characteristics. STRATEGY MUST BE DOCUMENTED. Cases identified by SMQs should be reviewed for relevance (Case report form, MedWatch form, etc.) May need to develop organization specific or project specific (i.e., ad hoc) queries. Consider for development as SMQs.

Browser Demonstration SMQ View

Summary In this course, we:
Reviewed the structure, scope, and characteristics of MedDRA Were introduced to the “MedDRA Term Selection: Points to Consider” document and some of its specific principles Considered data quality issues and learned about the “Data Quality, Coding and MedDRA” presentation Were introduced to the “MedDRA Data Retrieval and Presentation: Points to Consider” document and some specific retrieval and query examples Learned about Standardised MedDRA Queries (SMQs)

MSSO Contacts Mail Telephone Fax Products and Services VAR1/MSSO
12011 Sunset Hills Road Reston, VA, USA Telephone Toll-free Worldwide (AT&T) Fax Products and Services

MSSO Contacts (cont) To Subscribe by E-mail Web site Help desk Phone
Web site click on “Subscribe to MedDRA” Help desk Phone International AT&T Toll Free: Direct Dial (USA):

Acknowledgements COSTART Thesaurus Fifth Edition Copyright 1995 US Food and Drug Administration (FDA) Hoechst Adverse Reaction Terminology System (HARTS)© 1992 Aventis Pharma Japanese Adverse Reaction Terminology (J-ART), is a product of the Japanese Ministry of Health, Labour and Welfare (MHLW) MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) WHO Adverse Reaction Terminology (WHO-ART), Copyright World Health Organization Collaborating Centre for International Drug Monitoring

MedDRA® Training – Eisai Inc. February 2007

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MedDRA® Training – Eisai Inc. February 2007

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