Learn CDISC from CDISC! AP-Japan...Learn CDISC from CDISC! ! At the 2014 Asia-Pacific/Japan...

1
Learn CDISC from CDISC! At the 2014 Asia-Pacific/Japan Interchange! Register Here! SDTM Theory and Application CDASH Implementation Shannon Labout, CCDM Vice President of Education, CDISC SDTM Theory and Application: This two-day course consists of 1) a detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design, 2) a discussion of common implementation issues, and 3) exercises, including the annotation of CRFs and the creation of datasets that reinforce attendees' understanding of the SDTM and SDTM Implementation Guide for clinical data. CDASH Implementation: This full-day course provides attendees with an overview of the key concepts from the CDASH V1.1 standard. The course also includes in-depth implementation information for all of the CDASH domains, with hands-on exercises. This course covers the purpose and basic concepts of the CDASH standard, the relationship between CDASH and the other CDISC standards, conformance rules for CDASH implementations, challenges of collecting data in normalized structures, and CDASH Best Practice recommendations for data collection. Controlled Terminology Bron Kisler Vice President of Strategic Initiatives, CDISC This is a half-day course that provides a brief history of CDISC terminology, the primary objectives and guiding principles of Controlled Terminology, how terminology is developed and maintained, the CDISC Implementation Guide for Controlled Terminology, basics of using terminology, a discussion of codelist extensibility, accessing controlled terminology, and requesting new terms. Define-XML Sally Cassells Owner & Founder, Next Step Clinical Systems In the half-day Define-XML training course you will learn: 1) how to represent SDTM and ADaM metadata for datasets, variables and con- trolled terminology; 2) Define-XML 2.0 capabilities for representing value or parameter level metadata; 3) how to provide traceability of submission data; and 4) strategies for managing common Define-XML implementation issues. ADaM Implementation Monika Kawohl Principal Statistical Programmer, Accovion GmbH This one-day course discusses the purpose of ADaM, the basic principles of the ADaM data standard, the standard ADaM dataset structures and variables, ADaM metadata, maintaining the relationship between ADaM and SDTM, and how to apply ADaM to common analysis situations. Register Here! CDISC WEB- SITE LINK lin lin lin lin

Transcript of Learn CDISC from CDISC! AP-Japan...Learn CDISC from CDISC! ! At the 2014 Asia-Pacific/Japan...

Page 1: Learn CDISC from CDISC! AP-Japan...Learn CDISC from CDISC! ! At the 2014 Asia-Pacific/Japan Interchange!! Register Here! SDTM Theory and Application!!!! CDASH ! Implementation Shannon

Learn CDISC from CDISC! !At the 2014 Asia-Pacific/Japan Interchange!!

Register Here!

SDTM Theory and Application!!!!CDASH !Implementation

Shannon Labout, CCDM !Vice President of Education, CDISC!!SDTM Theory and Application:!This two-day course consists of 1) a detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design, 2) a discussion of common implementation issues, and 3) exercises, including the annotation of CRFs and the creation of datasets that reinforce attendees' understanding of the SDTM and SDTM Implementation Guide for clinical data.!!CDASH Implementation:!This full-day course provides attendees with an overview of the key concepts from the CDASH V1.1 standard. The course also includes in-depth implementation information for all of the CDASH domains, with hands-on exercises. This course covers the purpose and basic concepts of the CDASH standard, the relationship between CDASH and the other CDISC standards, conformance rules for CDASH implementations, challenges of collecting data in normalized structures, and CDASH Best Practice recommendations for data collection.

Controlled !Terminology

Bron Kisler!Vice President of Strategic Initiatives, CDISC!!This is a half-day course that provides a brief history of CDISC terminology, the primary objectives and guiding principles of Controlled Terminology, how terminology is developed and maintained, the CDISC Implementation Guide for Controlled Terminology, basics of using terminology, a discussion of codelist extensibility, accessing controlled terminology, and requesting new terms.

Define-XML Sally Cassells!Owner & Founder, Next Step Clinical Systems!!In the half-day Define-XML training course you will learn: 1) how to represent SDTM and ADaM metadata for datasets, variables and con-trolled terminology; 2) Define-XML 2.0 capabilities for representing value or parameter level metadata; 3) how to provide traceability of submission data; and 4) strategies for managing common Define-XML implementation issues.

ADaM !Implementation

Monika Kawohl!Principal Statistical Programmer, Accovion GmbH!!This one-day course discusses the purpose of ADaM, the basic principles of the ADaM data standard, the standard ADaM dataset structures and variables, ADaM metadata, maintaining the relationship between ADaM and SDTM, and how to apply ADaM to common analysis situations.

Register Here!

CDISC WEB-SITE LINK

lin lin lin lin