Home / CDISC Event Archives 2016

CDISC Event Archives 2016

Webinars

Agenda

  • Prostate Cancer TA Public Review

Panelists

  • John Owen, Project Manager, CDISC 

Agenda

  • Ebola TA Public Review
  • Malaria TA Public Review

Panelists

Agenda: 
• TRANSFoRm Project

Panelist(s): 
• Information to come

Agenda

  • Diabetic Kidney Disease TA Public Review

Panelists

Agenda:

  • Implementation of ADaM Basic Data Structure for Cross-over Studies

Panelists:

  • Songhui Zhu, A2Z Scientific

Agenda

  • Controlled Terminology Updates

Panelists

  • Bernice Yost, DIrector of Terminology, CDISC

Agenda

Panelists

  • CDISC SHARE Team Members:
    • Dr. Lauren Becnel, Senior Director of Biomedical Informatics and Alliances
    • Anthony Chow, Sr. Manager, Technical Development

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: 
• BRIDG Overview. Biomedical Research Integrated Domain Group (BRIDG) is a domain analysis model that represents the realm of protocol-driven clinical, pre-clinical, translational and basic research.


Panelist(s): 
•Dr. Lauren Becnel, Senior Director of Biomedical Informatics and Alliances, 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

Symposium

Date & Location:

01 June 2016

University of Tokyo, Tetsumon Memorial Hall

14th Floor, Faculty of Medicine Experimental Research Building

This special Symposium is targeted towards clinicians and other clinical researchers interested in ways to represent clinical research data that supports the development of new therapies for patients. The Clinical Data Interchange Standards Consortium (CDISC) has now led the consensus-based development of standards for over 25 different therapeutic areas (TA), and these standards are now being required by PMDA and FDA for data submitted to support the approval of new biopharmaceutical products. This course will provide an overview of CDISC and its global standards for clinical research, along with details on the process for developing TA standards and how to participate in the comment periods during the development process. The value (in terms of data quality and ROI) of using CDISC standards from the start of a research study will be emphasized.

Date & Location:
Friday, 30 September 2016
2:00 - 5:00pm
North Bethesda Marriott and Conference Center

Bethesda, MD

This Symposium will provide an overview of CDISC and its suite of harmonized and curated standards for clinical research. These are electronically available via the Shared Health and Research Electronic Library (SHARE), CDISC’s metadata repository. In terms of data quality and ROI, the value of using CDISC standards from the start of a research study will be discussed. Details on the process for developing TA standards and information on how researchers can actively participate in the development stages and/or the comment periods will also be covered.Objectives:

 

Read the full description.

CDISC and EMBL/EBI Symposium

 

Date & Location:

Friday, 21 October 2016

10:00am - 1:00pm

EMBL European Bioinformatics Institute

Cambridge, UK


This Symposium will provide an overview of CDISC and its suite of harmonized and curated standards for clinical research. These are electronically available via the Shared Health and Research Electronic Library (SHARE), CDISC’s metadata repository. In terms of data quality and ROI, the value of using CDISC standards from the start of a research study will be discussed. Details on the process for developing TA standards and information on how researchers can actively participate in the development stages and/or the comment periods will also be covered.

Read the full description.

 

Deadline for registration is Monday, 03 October 2016

External Events

Visit CDISC at the SCDM 2016 Annual Conference

 

Sheraton San Diego Hotel and Marina

San Diego, CA

 

CDISC can be found at Booth #101

 

Exhibition Schedule:

Sunday, September 11, 2016 from 06:00PM to 08:00PM
Monday, September 12, 2016 from 10:00AM to 06:00PM
Tuesday, September 13, 2016 from 10:00AM to 03:30PM

 

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

 

Interchanges

 

 

 

 

Dates & Location:

26 - 30 September 2016

Bethesda North Marriott Hotel and Conference Center

5701 Marinelli Road

North Bethesda, Maryland 20852 USA

 

Registration:

Registration for the CDISC 2016 International Interchange is now open!

To register and pay by credit card, click here.

To register and pay by invoice, click here.

Event Fees available here.

 

Schedule at a Glance:

Monday (26 September) - Authorized Education Courses

Tuesday (27 September) - Authorized Education Courses

Wednesday (28 September) - Main Conference

Thursday (29 September) - Main Conference

Friday (30 September) - Authorized Education Courses