portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC...

27

Transcript of portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC...

Page 1: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 2: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 3: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 4: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 5: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 6: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 7: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 8: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 9: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 10: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 11: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 12: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 13: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 14: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 15: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 16: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 17: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 18: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 19: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 20: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 21: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 22: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 23: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 24: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 25: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 26: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled
Page 27: portal.cdisc.orgportal.cdisc.org/CDISC User Networks/Europe/English... ·  · 2010-07-12CDISC Basics, SDTM, ADaM, Advanced Topics More anticipated -- 8 courses for CBER scheduled

SDTM AND ADaM: HANDS-ON SOLUTIONS - sgs.com · 3 CDISC: STANDARDS REVIEW CDISC end-to-end ! • CDASH identifies the (e)CRF data collection fields • SDTM defines a standard structure

SDTM AND ADaM: HANDS-ON SOLUTIONS - sgs.com · 3 CDISC: STANDARDS REVIEW CDISC end-to-end ! • CDASH identifies the (e)CRF data collection fields • SDTM defines a standard structure

Cdisc sdtm implementation_process _v1

Cdisc sdtm implementation_process _v1

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

DIA Annual Meeting – Preparing to Share CDISC SDTM - Celerion

DIA Annual Meeting – Preparing to Share CDISC SDTM - Celerion

Generation of real-time SDTM datasets and metadata through a generic SDTM converter mechanism CDISC (CDASH/SDTM) integration into OC/RDC Peter Van Reusel.

Generation of real-time SDTM datasets and metadata through a generic SDTM converter mechanism CDISC (CDASH/SDTM) integration into OC/RDC Peter Van Reusel.

1. © CDISC 2014 Stetson Line, Team Lead 2 2014 CDISC Intrachange SDTM Rules Sub-team Update.

1. © CDISC 2014 Stetson Line, Team Lead 2 2014 CDISC Intrachange SDTM Rules Sub-team Update.

From Source Data to SDTM - · PDF fileFrom Source Data to SDTM Steve Kirby and Nancy Wang . ... SDTM/ADaM Mapping Process ... (OPEN CDISC, Web SDTM, SAS DDI)

From Source Data to SDTM - · PDF fileFrom Source Data to SDTM Steve Kirby and Nancy Wang . ... SDTM/ADaM Mapping Process ... (OPEN CDISC, Web SDTM, SAS DDI)

CDISC (CDASH/SDTM) integration into OC/RDC

CDISC (CDASH/SDTM) integration into OC/RDC

CDISC SDTM Domain Presentation

CDISC SDTM Domain Presentation

Traceability between SDTM and ADaM converted analysis ...portal.cdisc.org/CDISC User Networks/Europe/English Language... · SDTM and ADaM converted analysis datasets ... CDISC SDTM

Traceability between SDTM and ADaM converted analysis ...portal.cdisc.org/CDISC User Networks/Europe/English Language... · SDTM and ADaM converted analysis datasets ... CDISC SDTM

CDISC SDTM 3.1.3 Validation Rules - PharmaSUG

CDISC SDTM 3.1.3 Validation Rules - PharmaSUG

CDISC SDTM/ADaM Pilot Project

CDISC SDTM/ADaM Pilot Project

Required Electronic Submissions to CDER / CBER · 10/8/2015  · FY2013, FY2014, FY2015 (Q1-Q3) Number (%) of NDAs with Study Data Submissions in CDISC SDTM* Fiscal Year # of Submissions

Required Electronic Submissions to CDER / CBER · 10/8/2015  · FY2013, FY2014, FY2015 (Q1-Q3) Number (%) of NDAs with Study Data Submissions in CDISC SDTM* Fiscal Year # of Submissions

CDISC SDTM/ADaM Pilot Project - World Wide Web … Transport Company B ADaM Derived ... CDISC SDTM / ADaM Pilot Project ... (real clinical trial data, warts and all) CDISC SDTM domains

CDISC SDTM/ADaM Pilot Project - World Wide Web … Transport Company B ADaM Derived ... CDISC SDTM / ADaM Pilot Project ... (real clinical trial data, warts and all) CDISC SDTM domains

Implementing CDISC LAB, ODM and SDTM in a Clinical Data ... · Implementing CDISC LAB, ODM and SDTM in a ... •Conversion Oracle DB XML ... Export study data to SDTM 3.1.1

Implementing CDISC LAB, ODM and SDTM in a Clinical Data ... · Implementing CDISC LAB, ODM and SDTM in a ... •Conversion Oracle DB XML ... Export study data to SDTM 3.1.1

Presentation on CDISC- SDTM guidelines.

Presentation on CDISC- SDTM guidelines.

Metadata Driven Programming for CDISC SDTM … Driven Programming for CDISC SDTM using SAS Kishore Shyamala Domain Clinical Data Sciences Private Limited 1 PhUSE Single Day Event –

Metadata Driven Programming for CDISC SDTM … Driven Programming for CDISC SDTM using SAS Kishore Shyamala Domain Clinical Data Sciences Private Limited 1 PhUSE Single Day Event –

CDISC® SDTM Conversion Made Easy with CDISC Express

CDISC® SDTM Conversion Made Easy with CDISC Express

BetterManagement Presents Results and Lessons from the CDISC SDTM

BetterManagement Presents Results and Lessons from the CDISC SDTM

CDISC Roadmap Outline: Further development and · PDF fileof CDISC, the CDISC ODM team, any ... – SDTM, ADaM ... – Many relicts from SAS Transport format. Harmonisation of SDTM

CDISC Roadmap Outline: Further development and · PDF fileof CDISC, the CDISC ODM team, any ... – SDTM, ADaM ... – Many relicts from SAS Transport format. Harmonisation of SDTM