Agenda
Monday, August 28, 2006 |
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8:30 A.M
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Instructors Welcome, Introduction of Participants
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9:00 A.M
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Regulatory History of Highlights coding
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9:30 A.M |
XML Basics
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SPL document structure
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How to review an SPL document without specialized software
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Understanding elements, tags, attributes, values, etc.
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The purpose and effects of the SPL schema
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How the stylesheet renders SPL
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Effects of mistakes in an SPL document - an overview
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10:00 A.M
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Break
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10:15 A.M
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Theory |
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The process of developing computer processable Highlights - Overview
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Regulatory strategy and other considerations
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Capturing individual concepts
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Composing a complete set of clinical Highlights data elements
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Coding
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12:30 P.M |
Lunch break |
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1:15 P.M
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Introduction to practice forms and required terminology browsers
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1:45 P.M
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Semantic and syntactic analysis of a Mock Highlights section – Creating a structured representation of Highlights content
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2:15 P.M |
Break |
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2:30 P.M |
Preliminary assessment of codability |
3:00 P.M
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Creating the data element structure
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Assembly of a customized spreadsheet to match the structured representation of Highlights content
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Includes step-by-step analysis and discussion of FDA's guidance documents
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Defining what can and what can not be captured based on the elements of the implementation model currently enabled by FDA's Implementation Guide
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5:00 P.M |
End Of Day 1
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Tuesday, August 29, 2006 |
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8:30 A.M
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Highlights concept coding |
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Part 1: VA/KP Problem List subset and SNOMED CT |
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Practical coding work using the Yatbu and Clue browsers |
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10:00 A.M
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Break
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10:30 A.M
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Highlights concept coding
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Part 2: LOINC and other code systems
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Includes practical coding work using LAB LOINC in an MS Access database, and strategies for finding terms and class codes in NDFRT
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12:00 P.M
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Lunch
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1:00 P.M
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Composing the section-specific XML code |
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Creating the XML Highlights code chunks for the individual sections and subsections of the Full Prescribing Information text |
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Practicing the Clinical Information Model syntax rules |
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Understanding the differences in rules for Highlights text and HLDEs |
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3:00 P.M |
Break |
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3:15 P.M
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Lessons learned and general Q&A |
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| 4:00 P.M | End of Workshop
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Registered participants are invited to submit questions and topics of special interest to info@qelabeling.com . |
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Register early! Space is limited!
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Participants are invited to bring personal laptop computers which will enable them to perform all exercises in parallel with the demonstration by the instructors.
It is not necessary to bring a laptop to get the full course benefit.
Participants are invited to submit special Highlights text scenarios for inclusion in the Mock Highlights section used for the workshop exercises.
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