Learn from standards experts during our monthly webinars.

 

Access to past webinars can be found at the bottom of this page.

CDISC Webinar Series: CDISC The Protocol Representation Model - An Introduction

Webinar to be rescheduled. Please watch for further information.

Webinar Description:

The CDISC Protocol Representation Model (PRM) V1 has been developed to facilitate the exchange of clinical research data, allowing studies to be initiated more rapidly, and supporting machine- and human-understandable decision support.  . The PRM is aligned with the Biomedical Research Integrated Domain Group (BRIDG) Model, a model that represents protocol-driven biomedical/clinical research. It was developed to provide an overarching model that could readily be understood by domain experts and would provide the basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare.  This session will provide an overview of the model and its contents which include the flowing areas:

  • Common Protocol Information – this includes the basic information about the study, the study document and the people and organizations involved
  • Clinical Trial Registry (CTR) – this includes the information/elements for trial registration (e.g. for EudraCT, clinicaltrials.gov or the WHO International Clinical Trial Registry Platform) protocol/study tracking for management purposes, and study summary information from SDTM
  • Eligibility Criteria – the basic criteria for inclusion and exclusion of a subject in a study
  • Study Design – including experimental design (arms and epochs) and the schedule of activities (visits and planned assessments and interventions)

The session will also include a discussion of the plans and uses of the PRM.

 

Presenters:

Lisa Chatterjee, Vice President, Healthcare Data Standards, Digital Infusion, Inc

David Gemzik, Vice President, Implementation Services Medidata Solutions

Rebecca Kush, CDISC President & CEO

Diane Wold, Manager, Data Standards, GSK

CDISC Webinar Series: ADaM: An Overview

14 October 2010

11:00 - 12:30 Eastern

Courses Description

The webinar will introduce the fundamentals and principles of ADaM and will explain  details of the standard structures for analysis datasets. Finally the webinar will describe the current ADaM team developments and plans for the future.

 

Presenters

Nate Freimark, Lead Programmer at Omnicare, Inc. (ADaM Team Lead)
Jack Shostak, Associate Director of Statistics at Duke Clinical Research Institute
Susan Kenny, Director Statistical Programming at Inspire Pharmaceuticals, Inc.

 

Online Registration

Offline Registration

**Special Webinar Presentation** How to talk to your management about CDISC

29 September 2010

Presented by Frank Rockhold, Senior Vice President, Global Clinical Safety & Pharmacovigilance, GSK

10:00 Eastern

Embracing standards in an organization or across an industry can require substantial amounts of financial investment and behavioral change.  The individuals within an organization who can sponsor and drive such change are usually far removed from the day to day work that benefits from the implementation of standards.  Thus, it is important for the experts in standards to be able to simply and clearly communicate with the decision makers in a way that make obvious the need for change.  This discussion will focus on how to communicate the imperative of moving to standards in clinical research.

 

Online Registration

Offline Registration

 

CDISC Webinar Series: Key Messages from CDISC and FDA

Date and Time

29 June 2010

Noon EDT

Purchase the Archived Webinar Here (online)

Purchase
the Archived Webinar Here
(offline)

 

If you missed the webinar on Key Messages from CDISC and FDA (CDER and CBER) on June 29, it’s not too late to hear our expert panel give the latest information about improving your clinical research processes and regulatory reviews through the use of standards.  

What is covered in this 90 minute webinar:

 

  • Learn how the full suite of CDISC standards (from protocol representation through analysis and reporting) will help you avoid costly legacy data conversions and save time and money on your next clinical research study.   
  • Learn the value of the new CDISC Protocol Representation Model in preparing for clinical trial registration, eSubmissions, clinical study reports and publications and using EHRs for research.
  • Hear preliminary results from the most recent CDISC industry survey and a summary of key messages from CDISC.    
  • Listen as CDER and CBER representatives present and discuss their Standards Implementation Plans and provide up-to-date information for those planning eSubmissions to these FDA centers. From the presentations and Q&A session, learn more details on which FDA offices are accepting SDTM submissions, and what their expectations are.

Expert Panel:

Rebecca Kush, CDISC President and CEO
Amy Malla, MT(ASCP), PMP, CQA, CBER
Charles Cooper, MD, CDER
Frank Newby, CDISC COO

CDISC Webinar Series: Healthcare Link Interoperability Network

Date and Time

7 June 2010

10:00 AM EDT

Online Registration

Offline Registration Form (xls)

 

This webinar will report on the Healthcare Link initiative, a standards-inspired innovation that links healthcare systems such as electronic health records (EHR) and research systems such as EDC and protocol development.  CDISC has engaged the EHR community through the standards adaption organization IHE, and created the Retrieve Form for Data-capture (RFD) profile in 2003.  Since then, new integration and content profiles have been released every year which augment and extend the original connection.  The webinar will cover the early work around RFD, and will continue through more recent profiles such as the CDASH-based Clinical Research Document, and the brand new Redaction Services.  Ultimately, all of the EHR activities described in a research protocol will be automated through the business process integration profile Retrieve Process for Execution.  The webinar will also report on the various testing, demonstrations, and promotional activities at CDISC, DIA, IHE, and HIMSS.  Future developments and synergies with the BRIDG and SHARE initiatives will be covered.
 
Presenters:
Landen Bain, CDISC Liaison to Healthcare
Chris Connor
David Iberson-Hurst, CDISC Technical Architect

CDISC HITSP Webinar

Understanding the New HITSP Clinical Research Interoperability Specification and Related Constructs

Date and Time
Thursday, 19 November 2009
13:00 – 15:00hrs  Eastern

The Archived Webinar can be found at the bottom of the HITSP Archive Page

What you will learn
HITSP has recently released several documents related to Clinical Research for public comment. During this 2-hour webinar, participants will learn the overall structure and fundamentals of HITSP’s new Clinical Research Interoperability Specification (HITSP IS158) and its underlying constructs, capabilities and service collaborations.

 

Registration

Participation in the webinar is complimentary, but advance registration is required.

To register directly, visit:
https://www.gotowebinar.com/register/281341224

Access
Participation during the live webinar requires both telephone and Internet connections.
Dial 866-951-1151, access code 3835420

 

Further details

Study Data Tabulation Model Implementation Guide v3.1.2 - An Overview

29 October 2009

11:00 - 12:30 EST

Online Registration

Offline Registration

 

In early 2009, CDISC released the SDTM v1.2 and the SDTMIG (SDTM Implementation Guide) v3.1.2.  In this webinar presentation, we will provide information on the changes, additions, and enhancements made since the last releases (SDTM v.1.1 and SDTMIG v3.1.1) in mid-2005. Most changes have been designed with backward compatibility in mind.

Version 3.1.2 of the SDTMIG includes several domains that were released after Version 3.1.1 as well as domains that were completely new in version 3.1.2.  These include Microbiology, Pharmacokinetics, Findings About, Clinical Events, Protocol Deviations, and Drug Accountability.

In addition, the SDS Team corrected known errors, and made many improvements to the SDTMIG document, including the following:

  • Many general and domain-specific assumptions were added
  • Existing assumptions were expanded or clarified 
  • Many more examples were added for previously published domains
  • Domain examples were moved into the relevant domain section rather than appearing in a separate Examples section

 

Learning Objectives

Learn what is new in the SDTM v.1.2 and SDTMIG v3.1.2:

  • Become familiar with the major changes to the  SDTM v.1.2 and SDTMIG v3.1.2
  • Learn about the new SDTMIG domains for Microbiology, Pharmacokinetics, and Clinical Events
  • Understand how to use the new domain, Findings About
  • Get an insight into the new Trial Design changes

Speakers

Chris Tolk, Director Terminology, CDISC

Fred Wood, Vice President, Data Standards Consulting, Octagon Research Solutions

Diane Wold, Director, Data Standards, GlaxoSmithKline

CDISC CDASH Webinar Part 1

CDISC Data Standards from Collection to Submission – Effectively Mapping from CDASH to SDTM.

Series Abstract

This is a 2-part webinar presentation that will focus on the CDISC CDASH (Clinical Data Acquisition Standards Harmonization) data collection standard and how it maps to the CDISC SDTM (Study Data Tabulation Model), which is the recommended format for e-data submissions to the FDA.

Webinar 1

Date: Thursday, July 30, 2009
Time:

Chicago 07:30 - 09:00 CDT
New York 08:30 - 10:00 EDT
Los Angeles 05:30 - 07:00 PDT
Central European Time 14:30 - 16:00
UK 13:30 - 15:00

To register for Webinar 1


Click here for on-line registration (credit cards only)

Click here for off-line registration (non-credit card payments)

Description
Webinar One will cover the CDASH basics; assumptions, designations, controlled terminology and how use of the CDASH standard will optimize data collection from both the Site and Sponsor perspectives.

Learning Objectives
At the conclusion Webinar 1, participants should be able to:

  1. Describe the benefits of CRF standardization for investigative sites and other stakeholders in clinical research.
  2. Explain how CDASH collection fields can be used to create basic CRFs and XML style sheets and how this will facilitate good CRF design and minimize collection of unnecessary data elements and ensure consistency across a clinical program.
  3. Describe how CDASH data collection fields are related to other CDISC standards, specifically the SDTM and CDISC Controlled Terminology.


Speakers
Melissa Binz, Director, Central Standards Group, Wyeth
Rhonda Facile, Director, CDASH Project, CDISC
Shannon Labout, Principal Consultant

Speaker Bios