1. BiomedGT Wiki support for CTCAE update/ Creating a pre-coordinated OWL file Sherri de Coronado NCI CBIIT/ EVS May 1, 2009

2. Features and Process used for Wiki – Tabular representation of CTCAE – “Leave a Comment” feature added to discussion – Term pages and edit forms created for editing each cycle – Proposal processing at end of an editing cycle (by scripts) – Excel report run multiple times per editing cycle – Publication of an updated version after each round of editing

3. First Editing Cycle Organized by CTCAE Categories

4. First Editing Cycle (cont’d)

5. Make a Proposal for Changing a Term Created templates to display term and proposal in table format. Original Proposal

6. Discussion: Leave a Comment New formatOld format

7. Editing Cycle One: New /Edit Proposal Using features of Semantic Forms, created a proposal mechanism with a drop down menu for users to select Proposal status of Edit, Split or New Term.

8. Editing Cycle 2: Editing Grades

9. How was CTCAE3 loaded? Existing tools and custom script used to convert and load “LexWiki” format into Wiki – CTCAE3 available as a spreadsheet – Mapped to LexGrid model, generated LexGrid XML and loaded into LexGrid database using LexGrid API – Used Protégé LexWiki plugin to get into Protégé OWL and from there into the BiomedGT Wiki – Similar process used to load updated version

10. Post Work Group Processing Public Comments collected by spreadsheet Comments incorporated into revised spreadsheet Spreadsheet dumped to AccessDB and loaded to LexBIG PDF file populated from the LexBIG file Create OWL file from non-precoordinated version Possible additional changes after steering and governance reviews

11. Creating OWL file Shallow hierarchy consisting of SOC terms, AE terms and pre-coordinated child terms with grades, e.g. “Grade 3 Febrile Neutropenia” Added – Unique Concept Code – MedDRA code as property – Synonyms (LLTs from MedDRA) – Definitions for AE terms (from NCIt/ or created) – Definitions for Child terms are Grade descriptions from spreadsheet – Basic grade terms with “Is_Grade” relationship to AEs

12. Grade Terms Concept Code Synonyms - LLTs Preferred Name Is_Grade Relation Def

13. Acknowledgements Mayo Clinic – Traci St. Martin – Deepak Sharma – Guoqian Jiang – Tom Johnson Dionne Associates – Bob Dionne Lockheed-Martin – Nels Olsen – Joanne Wong – EVS Editors Northrup Grumman – Wilberto Garcia – David Yee NCI CBIIT – Gilberto Fragoso – Larry Wright