Andrew Newbigging

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Clinical Coding

• Andrew Newbigging
• Managing Director

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Agenda

• Background
• Main requirements
• Development plan
• Example screens

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Background

• Background
• Large pharma and CROs already have coding systems
  in place
• Smaller companies and academic groups may not
  have existing systems
• New legal requirements in Europe for all AEs to
  be coded in MedDRA
• Additional need to code against a drug dictionary
  and possibly a generic medical thesaurus (eg.
  SNOMED)

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Main requirements

• Manage multiple dictionaries and versions of
  dictionaries
• Auto-encoding
• Browsing, searching and manual selection of terms
• Review and authorisation

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Development approach

• Minimise changes to MACRO
• Changes in MACRO should be generic ie. not
  linked to any particular coding scheme
• MedDRA browser and auto-encoder will be licensed
  from Software Technics
• Note InferMed can not re-distribute MedDRA codes

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Development timescales
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Study definition

• New question type Thesaurus
• Specify dictionary and version in question
  definition

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Data entry / review

• New user permissions to control access to coding
• Authorised users will see new button against
  thesaurus questions which will link to the code
  browser and search tool

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Data entry / review

• Audit trail will record
• Free verbatim text
• Clinical code and full path in the terminology
• Coding Status
• Dictionary Name
• Dictionary Version
• Time and Timezone
• Authorised users can modify Coding Status

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Autocoding

• Autocoding will be similar to Batch Validation
  module
• Can select by study
• By site
• By patient
• Status messages logged in a text file
• Results screen will allow quick confirmation of
  correct terms

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Questions ?