Learn from standards experts during our monthly webinars.

 

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

CDISC Public Webinar Series - Standards Updates and Additions - Controlled Terminology Quarterly Updates - Q3 2018

THU, 5 JUL 2018 11:30 AM CST
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Join the Controlled Terminology team for our quarterly webinar, which will highlight changes to Controlled Terminology Package 34 and discuss Public Review for Package 35, which runs until 20 July 2018.

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

Agenda:
- Controlled Terminology, Package 34 Publication
- Controlled Terminology, Package 35 Public Review

Date and Time

Thursday, 5 July 2018

11:30 AM - 12:30 PM CDT

Panelists

  • Erin Muhlbradt, CDISC Project Lead, NCI EVS
  • Chris Gemma, Project Manager, CDISC

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CDISC Members-Only Mini-Training Series - ODM v2 Overview

Date and Time:
THU, 25 OCT 2018, 10:00 AM - 11:30 AM Central Daylight Time

Description:

ODMv2 represents a significant step toward modernizing the CDISC Data Exchange Standards to spark more efficient methods of data exchange throughout the clinical research data lifecycle. This presentation will discuss the vision and drivers motivating the advances in ODMv2. The CDISC Data Exchange Standards play a major role in supporting standards-based automation and the planned advances in these standards increase the opportunities to develop new, innovative software tools based on these standards.

ODM-XML v1.3.2 is the most current version of the standard. A number of CDISC standards have been developed by extending ODM-XML including:  Define-XML, SDM-XML, Dataset-XML, CTR-XML and CT-XML. ODM-XML provides a common base structure for these standard extensions easing the learning curve and implementation complexity.

Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org

Note: Please use your corporate e-mail address to register for this webinar. This is to confirm your CDISC membership.Confirmations will be sent out within a few days after your completed registration. 

Presenter

  • Sam Hume, DSc., VP, Data Science, CDISC

Webinar Language: English

 

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CDISC Public Webinar Series - Standards Updates and Additions - HIV TAUG v1.0 Public Review

TUE, 12 JUN 2018 10:00 AM - 11:30 AM CDT
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Description

CDISC invites you to attend the Public Review webinar for Version 1.0 of the HIV Therapeutic Area User Guide (TAUG-HIV). TAUG-HIV v1.0 was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to studies for the treatment and prevention of HIV and the necessary metadata to represent such concepts consistently with the CDISC standards, such as CDASHSDTM and ADaM.

CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research quality and processes for the benefit of all.

To view the user guide: TAUG-HIV v1

Topics included in this TAUG include:

  • Diagnosis of HIV
  • Risk Factors and Mode of Transmission
  • Menstrual History and Pelvic Examinations
  • Mother-Infant Pairs in HIV Studies
  • HIV Treatment with Oral Antiretroviral Therapy (ART)
  • Pre-Exposure Prophylaxis (PrEP)
  • CD4 Counts, Viral Detection, and Viral Load
  • Drug Susceptibility including phenotypic drug sensitivity and genetic resistance calculators
  • Several Analysis concepts including the FDA snapshot analysis and pregnancy outcome analysis

Date and Time
TUE, 12 JUN 2018
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

  • Amy Palmer, Director, Standards Development, CDISC
  • Laura Butte, Project Manager, Data Standards, Critical Path Institute
  • Nate Freimark, Vice President, Clinical Programming and Data Standards, The Griesser Group
  • Bess Leroy, Metadata Engineer, CDISC
  • Jon Neville, Metadata Engineer, CDISC
  • Diane Wold, Sr. Director, Standards Development and Modeling, CDISC

CDISC Public China Webinar - CDASH v2.0

Date and Time
FRI, 22 JUN 2018 10:00 AM - 11:00 AM BEIJING TIME

Description

This webinar will be presented in Mandarin.

The CDISC Foundational Standard for data collection, CDASH, establishes a standard way to collect data across studies and sponsors so that formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.  This webinar will address CDASH v2.0, which comprises the CDASH Implementation Guide  v2.0, the CDASH Model v1.0, and CDASHIG metadata tables to define basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms.

Webinar Agenda:

  • CDASH v2.0 简介 (CDASH v2.0 Overview)
  • CDASH标准介绍 (CDASH Standards Introduction)
  • CDASH IG v2.0主要变化 (CDASH IG v2.0 Main Updates)
  • CDASH Metadata 和CDASH Model 介绍(CDASH Metadata and CDASH Model introduction)

Webinar Language
Mandarin

Presenters

  • Lily Zhao, Director, Data Management, PAREXEL
  • John Wang, Associate Director of Statistical Analysis, dMed Global

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CDISC Public Webinar - CDISC Newcomers Informational Webinar

Description

New to the world of CDISC Standards? This webinar, presented by some of the foremost CDISC experts, will cover the fundamentals to get you up to speed on the what, how, and why of CDISC standards.  We will address such topics as:

  • The need for global standards in the current industry environment,
  • An overview of the CDISC Model
  • Regulatory requirements
  • Use cases for CDISC Standards.

Date and Time
THU, 28 JUN 2018
8:00 AM - 9:30 AM CDT // 3:00 PM - 4:30 PM Central European Time

Webinar Language
English

Presenter

  • Peter Van Reusel, Chief Standards Officer, CDISC

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CDISC Public Asia Webinar Series - Standards Updates and Additions - Controlled Terminology Quarterly Updates - Q1 2018

This is a simulated live webinar, which is a rebroadcast of an original webinar, and allows attendees to ask questions and participate in chat. Answers to attendee questions will be answered by subject matter experts and provided 24 hours after the webinar's completion.

The webinar will highlight changes to Package 33 CT and discuss public review for Package 34, which will run until 20 April, and will be published on 29 June 2018.

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

Agenda:

Date and Time

Thursday, 19 April 2018

9AM-10AM Beijing Time

10AM-11AM Japan Standard Time

Panelists

  • Erin Muhlbradt, CDISC Project Lead, NCI EVS
  • Chris Gemma, Project Manager, CDISC

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CDISC Asia Webinar Series - Members Only - 'Big Data’ Analytic Methods to Simplify Risk-Based Monitoring

Date and Time
TUE, 17 APR, 2018

09:00 AM - 10:30 AM Beijing Time

10:00 AM - 11:30 AM Japan Time

Description

This is a simulated live webinar, which is a rebroadcast of an original webinar, and allows attendees to ask questions and participate in chat. Answers to attendee questions will be answered by subject matter experts and provided 24 hours after the webinar's completion.

Traditional methods for implementing risk-based monitoring stress the need for early assessment, planning and development work to ensure that risks are aligned with study needs. Conversely, a Big Data approach de-prioritizes much of this early work in favor of allowing the data itself to guide the analysis and risk profile for the study.

This webinar will show how clinical data automatically flows from EDC platform into a clinical analytics system for risk assessment, data visualization and fraud detection. Examples will be given from multi-venue studies, which indicate a high risk of non-compliance and a significant probability of fraud at several sites. All of this is done without the need for extensive custom programming or for transforming data into a proprietary data mart or warehouse.

Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org

Note: Please use your corporate e-mail address to register for this webinar. This is to confirm your CDISC membership. Confirmations will be sent out within a few days after your completed registration.

Webinar Language
English

Presenter

  • Jon Roth, Vice President of Data Sciences and Biometrics, Biorasi

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CDISC Public Webinar: Type 1 Diabetes Program Kick Off

TUE, 17 APR 2018 10:00 AM CST
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Agenda:

CDISC is embarking on a three-year Type 1 diabetes standards development program, which covers the areas of Pediatrics, Devices, Prevention and Exercise and further develops the already-released Diabetes v1.0 and ADaM Diabetes Supplement v1.0 standards. This webinar will introduce an overview of the program in order to engage active feedback and participation from the diabetes community.

Date and Time

Tuesday, 17 April 2018

10AM-11:30AM CST

Panelists

  • John Owen, Project Manager, CDISC

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CDISC Members-Only Mini-Training Series - Preparing ADaM Data Sets and Related Files for FDA Submission

Date and Time
THU, 14 JUN 2018, 10:00 AM - 11:30 AM Central Daylight Time

Description

Join experts from the CDISC ADaM team to learn how to assemble analysis data and related files for submitting NDAs and most BLAs to FDA CDER and CBER.  Understand regulatory requirements and learn recommendations for issues that aren't so clear cut. Deliverables discussed include analysis datasets, other files related to analysis datasets, analysis programs, data definition files (define.xml) and the Analysis Data Reviewers Guide (ADRG).

Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org

Note: Please use your corporate e-mail address to register for this webinar. This is to confirm your CDISC membership.Confirmations will be sent out within a few days after your completed registration. 

Webinar Language
English

Presenter

  • Sandra Minjoe, Senior Principal Clinical Data Standards Consultant, PRA Health Sciences

Panelists

  • Nate Freimark, Vice President, Clinical Programming and Data Standards, The Griesser Group
  • John Troxell, ADaM Implementation Advisor, The Data Standards Consulting Group

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CDISC Public Webinar Series - Standards Updates and Additions - Controlled Terminology Quarterly Updates, Q1 2018

 WED, 4 APR 2018 10:00 AM CST
REGISTER NOW

The webinar will highlight changes to Package 33 CT and discuss public review for Package 34, which will run until 20 April, and will be published on 29 June 2018.

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

Agenda:
- Controlled Terminology, Batch 33 Publication
- Controlled Terminology, Batch 34 Public Review

Date and Time

Wednesday, 4 April 2018

10AM-11AM CST

Panelists

  • Erin Muhlbradt, CDISC Project Lead, NCI EVS
  • Chris Gemma, Project Manager, CDISC

Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by Citrix).