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CDISC Event Archives 2016

Webinars

Learn the fundamental principles between CDASH for Data Collection and SDTM for Data Tabulation to understand why there are two standards for handling the same data at different points in the data lifecycle. 

Agenda: 

  • What is SDTM and why do we need it?
  • What is CDASH and why do we need it?
  • How are CDASH & SDTM the same?
  • How and why are CDASH & SDTM different?
  • How do CDASH & SDTM work together?
  • 30 Minute Q&A Session 

Who Should Attend?

  • Clinical Data Managers
  • Clinical Programmers
  • SDTM Programmers
  • Statistical Programmers
  • Biostatisticians
Panelists: 
• Shannon Labout, CCDM, Vice President of Education, CDISC 
• Kit Howard, Director of Education, CDISC 
• Gary Walker, Associate Director, Statistical Programming, Quintiles 
 

Agenda

  • Prostate Cancer TA Public Review

Panelists

  • John Owen, Project Manager, CDISC 

Agenda

  • Ebola TA Public Review
  • Malaria TA Public Review

Panelists

  • TRANSFoRm Project: ODM-XML Extension in User Interface for Mobile Apps
    • Agenda
      • ODM-XML integration in generating mobile applications 
    • Panelists
      • Vasa Curcin, Lecturer in Health Informatics, King’s College London 
      • Stanisław Saganowski, Wrocław University of Science and Technology, Poland, Research Assistant
      • Piotr Bródka, Wrocław University of Science and Technology, Poland, Assistant Professor
      • Radosław Michalski, Wrocław University of Science and Technology, Poland, Assistant Professor
      • Brendan Delaney, TRANSFoRm Project 
  • Biomedical Concepts, SHARE and the Semantic Web
    • Agenda

Agenda

  • Diabetic Kidney Disease TA Public Review

Panelists

Agenda:

  • The World of Standards: CDISC and Beyond
    • Description: There are many standards available for defining safety and efficacy clinical trials data across industry, academia and government. Some are obvious, such as CDISC, but some are less well known. Some are required, others are highly recommended.  Most provide existing materials that can jumpstart research, save time and money and provide numerous other benefits.

Panelist:

  • Kit Howard, Director of Education, CDISC

Agenda

  • Controlled Terminology Updates
  • Terminology for Flow Cytometry

Panelists

  • Bernice Yost, Director of Terminology, CDISC
  • Craig Zwickl, Sr. Research Scientist, Eli Lilly 

Agenda

  • Controlled Terminolgy Quarterly Updates

Panelists

  • Bernice Yost, CDISC

Agenda

  • CT Updates
  • CDASH V2 Public Review
     

Panelists

Agenda

  • ADaMIG v1.1
  • OCCDS v1.0

Panelists

  • John Troxell, Accenture
  • Sandra Minjoe, Accenture

Agenda

  • RA TA Public Review
  • CVI TA Public Review

Panelists

Agenda

  • P25 Terminology publication release
  • P26 public review 

Panelists

  • Bernice Yost, CDISC 

Agenda

  • Education Updates

Panelists

  • John Ezzell, CDISC

Agenda: 

  • This webinar will address a topic related to Define-XML and ODM-XML.
    • Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the FDA what datasets, variables, controlled terms, and other specified metadata were used.
    • ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data.


Panelist(s): 

  • Jozef Aerts, CEO, XML4Pharma

Bringing together the “parallel universes” of healthcare delivery and healthcare research is a major endeavor, made possible by the rapid increase in adoption of electronic health records (EHRs), wearables, mobile devices, and other real-world data sources. There are clear opportunities to using healthcare-generated data for evidence generation in clinical research, along with the promise of reducing costs, streamlining processes, eliminating redundancies, and improving data quality.

 

However, there are significant differences in systems, standards, goals and cultures between the two ‘universes’, which must be addressed if we are to realize the benefits. There is not yet a clear path to utilizing data from these electronic sources and making it ready for use in research and regulated decision-making.  

 

Agenda: 
• Applied Use of CDISC Standards – A Case Study Using REDCap


Panelist: 
• Dr. Paul A. Harris, Vanderbilt University

 

Q&A Panelists:

• Sam Hume, CDISC

• Michael Ibara, CDISC

Agenda: 
• The Need for Human Intelligence in Assessing SDTM Conformance  

Panelist(s): 
• Fred Wood, Accenture

• Jerry Salyers, Accenture

• Kristen Kelly, Accenture

Agenda: 
• SDTM Trial Disease Assessment Domain 

Panelist(s): 
• Barrie Nelson, CDISC

• Melanie Paules, GSK

• Diane Wold, CDISC

 

Agenda:
• Overview of Medical Device Domains 
• 30 Minute Q&A Session 

Panelist(s):
• Kit Howard, CDISC

Agenda:

  • Reference Time Points
    • What is the difference between –STRF, --ENRF, --STRTPT/--STRTPT and –ENRTPT/--ENTPT variables in SDTM?
    • When should you use these variables?
    • Examples of how to populate these relative timing variables
  • 30 Minute Q&A Session

Panelists:

  • Lauren Shinaberry, Abbvie
  • Jerry Salyers, Accenture 

 

Agenda

  • LOINC 
  • 30 Minute Q&A Session 


Panelists 

  • Phil Pochon, Covance

External Events

Fit for Use Workstream Status

The CDISC SEND Team, in collaboration with the PhUSE Nonclinical Test Submission Forum Team, will be sharing the current status of the SEND usability pilot, the “Fit for Use” submission pilot. 

October 26, 2016 4:00 – 5:00PM EDT

To join this web conference, please use connection information at the SEND Fit for Use public wiki: http://wiki.cdisc.org/display/NSFFUW/Nonclinical+%28SEND%29+Fit+for+Use+Workstream+Home

Open to the Public - Please note this conference call is limited to 100 attendees.

SEND-compliant Dataset Submission Process and Nonclinical Test Submissions Discussions with FDA EData Team

Fundraiser

Here's What You Missed at CDISC and One Mind's Cowboy Up Event!

Click below to watch the video

Public Courses

Course Information:
Date/Time: 5-6 Dec 2016; 09:00-17:00
Instructor: Taku Shimizu
Course Language: Japanese (using English material with no simultaneous English translation)
 
Date/Time: 7 Dec 2016; 09:00-17:00

Course Schedule

Name2-day SDTM Theory and Application

Date/Time: 12-13 Sep 2016; 09:00-17:00

Instructor: Hiromi Yamamoto

Course Language: Japanese (using English material)

 

Name: 1-day ODM Implementation

Date/Time: 14 Sep 2016; 09:00-17:00

Instructor: Yoshiteru Chiba

Course Information:

Name: 2-day SDTM Theory and Application

Date/Time: 7-8 Nov 2016; 09:00-17:00

Instructor: Niels Both

Course Language: English

 

Name: 1/2-day ADaM Primer

Date/Time: 9 Nov 2016; 13:00-17:00

Instructor: Niels Both

Course Language: English

 

Name: 1-day ADaM Theory and Application

Date/Time: 10 Nov 2016; 09:00-17:00

Instructor: Niels Both

Course Information:
Date/Time: 26-27 Sep 2016; 09:00-17:00
Instructor: Gitte Frausing
Course Language: English
 
Date/Time: 26-27 Sep 2016; 09:00-17:00
InstructorShannon Labout
Course Language: English
 
Course Information:
Name: Special CDISC Symposium: Smarter Research Through CDISC Standards for Therapeutic Areas
Date/Time: 1 Jun 2016; 13:00-18:00
InstructorRebecca Kush and Barrie Nelson
Course Language: English
Location: University of Tokyo, Tetsumon Memorial Hall, 14th Floor, Faculty of Medicine Experimental Research Building, 7-3-1 Hongo, Bunkyo-ku, Tokyo 103-0033, Japan
Capacity: 300
 

Course Information:

Date/Time: 18-19 Jul 2016; 09:00-17:00
Instructor: Jerry Salyers
Course Language: English
 
Date/Time: 20 Jul 2016; 09:00-17:00
Instructor: Jerry Salyers
Course Language: English

 

Course Information:

Date/Time: 5-6 Sep 2016; 09:00-17:00
Instructor: Peter van Reusel
Course Language: English

 

Date/Time: 7 Sep 2016; 09:00-17:00
InstructorPeter van Reusel
Course Language: English

 

Course Information:
Date/Time: 20-21 June 2016; 09:00-17:00
Instructor: Jerry Salyers
Course Language: English
 
Date/Time: 22 June 2016; 13:00-17:00
InstructorJack Shostak
Course Language: English
 
Course Information:
Date/Time: 11-12 Apr 2016; 09:00-17:00
InstructorFred Wood
Course Language: English
 
Date/Time: 11-12 Apr 2016; 09:00-17:00
InstructorShannon Labout
Course Language: English
 
Course Information:
Date/Time: 2-3 Mar 2016; 09:00-17:00
Instructor: Fred Wood
Course Language: English
Note: Course canceled. Next opportunity in Emeryville, CA. Full course schedule here.
 
Date/Time: 4 Mar 2016; 09:00-13:00

Course Information:

Date/Time: 26-27 Jan 2016; 09:00-17:00
Instructor: Niels Both
 
Date/Time: 28 Jan 2016; 09:00-17:00
Instructor: Niels Both 

 

Register by 26 Dec 2015 to avoid late registration fees