Webinars

Webinars address industry hot topics, best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts. For more information about CDISC webinars, please reach out to us at cdiscwebinar@cdisc.org.

Date and Time:

TUE, 2 MAR 2021, 11:00 AM - 12:30 PM Eastern US Standard Time

Description :

Learn about the many current and forthcoming ADaM publications. ADaM is CDISC’s standard for data analysis and required for data submission to FDA (U.S.) and PMDA (Japan).

  • ADaM ADNCA v1.0 details the typical dataset that can be submitted to create PK parameters. ADNCA is a sub-class of BDS , and the guidance describes the differences and additions to BDS.
  • ADaM Implementation Guide v1.3 is a minor update of the ADaM Implementation Guide intended to improve alignment with the FDA Study Data Technical Conformance Guide .
  • ADaM Implementation Guide Medical Devices v1.0 is intended to address the typical statistical analysis needs for clinical trials collecting data on medical devices. The guide introduces three new data structures: ADaM Device-Level Analysis dataset (ADDL), Medical Device Basic Data Structure (MDBDS), and Medical Device Occurrence Data Structure (MDOCCDS).
  • ADaM Guidance for Ongoing Studies Disrupted by the COVID-19 Pandemic provides recommendations for addressing the analysis needs for data capturing epidemic/pandemic impacts on ongoing clinical trials and provides example ADSL and OCCDS datasets.
  • ADaM OCCDS v1.1 recently completed a second public review to address the addition of four new variables to allow multiple treatment-emergent or on-treatment flags to handle multiple periods or other analysis needs.
  • ADaM Oncology Examples details various oncology analysis needs using current ADaM dataset structures.
  • ADaM Questionnaire Supplements (ADQRS) sub-team recently published the first ADaM QRS supplement, which describes the structure of a typical dataset that could be used for summarization and analysis of the Geriatric Depression Scale Short Form (GDS-SF). The sub-team also released "readme" files, which provide the rationale for not developing ADaM supplements for four single-item questionnaires, ratings and scales, and made templates available for creating both types of documents.
  • ADaM Traceability Examples detail various traceability scenarios using current ADaM dataset structures.

Presenters:

Deb Bauer, Associate Director Biostatistics, Sanofi
Nancy Brucken, Standards Engineer, Clinical Solutions Group, an IQVIA business
Liana Forman, Associate Director Data Standards, Clinical Solutions Group, an IQVIA business
Brian Harris, Standards Developer, Senior Director, AstraZeneca
Luke Reinbolt, Lead Consultant, Clinical SAS Programmer Analyst, Navitas Data Sciences
Julia Yang, Senior Principal Clinical Statistical Developer, Medtronic


Date & Time:
TUE 16 MAR, 11:00AM-12:30PM ET

Description :

Join us for QRS Office Hours, an open forum to ask our QRS Team questions about the development and implementation of QRS Supplements and Terminology. Examples include:

  • Please explain the organization of the Controlled Terminology and Questionnaires, Ratings, and Scales pages on the CDISC website?
  • What are the rules for determining if a supplement should be in the Disease Response and Clin Classification (RS) domain?
  • What are our QRS naming rules for terminology?
  • How do we determine FACT/FACIT synonyms and terminology?
  • What is the status of representing logically skipped items in QRS?

Panelists:

  • Dana Booth, SDS QRS Subteam Co-Lead, CDISC
  • Steve Kopko, SDS QRS Subteam Co-Lead, CDISC
  • Barbara Lentz, Associate Director, Medical Standards, Bayer Healthcare

Date and Time:
THU 25 MAR 2021, 11:00AM-12:00PM ET

Description:

CDISC and the Pancreatic Cancer Action Network (PanCAN) are developing global, nonproprietary clinical metadata standards that build upon existing CDISC standards to create a Therapeutic Area User Guide (TAUG) for pancreatic cancer. The TAUG is intended to facilitate increased ease of global health data sharing and will include core precision medicine-focused concepts in pancreatic cancer.

CDISC TAUGs describe how to use CDISC standards to represent data in research studies pertaining to specific diseases and provide examples and guidance to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

Panelists:

  • Kathleen Mellars, Consultant Standards Developer, CDISC
  • Jon Neville, Sr. Standards Developer, CDISC
  • Alana St. Clair, Project Manager, CDISC

Date and Time:

TUE 30 MAR 2021, 11:00 AM - 12:00 PM Eastern US Standard Time

Description:

We invite you to meet industry veteran, Dave Evans, our new President and CEO, and hear about his plans to take CDISC forward as we quickly move toward a more technology-based standards future and cultivate deeper relationships with stakeholders throughout the clinical research ecosystem. The webinar will include a time for questions and discussions.

Dave is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions and as an expert in the areas of information architecture, data standards, regulatory compliance and quality governance. His extensive clinical data expertise and strong industry relationships, combined with his passion for integrating technology and standards, bring unique expertise to CDISC.

Presenters:

Dave Evans, President and CEO, CDISC

Webinar Language: English

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Date and Time:

THU 1 APR 2021, 11:00 AM - 12:30 PM Eastern US Standard Time

Description:

This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.

Presenters:

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Webinar Language: English

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Date and Time:
THU 8 APR 2021, 11:00 AM - 12:30 PM Eastern US Standard Time

Description:
This webinar will include a short demonstration of the CDISC Library, including new features added during the latest release. We’ll also cover common uses of the API and review key features and content planned for this year.

Presenters:
Anthony Chow, Director, Data Science, CDISC
Sam Hume, Vice President, Data Science, CDISC 


Webinar Language: English

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Date and Time:

THU 1 JUL 2021, 11:00 AM - 12:30 PM Eastern US Standard Time

Description:

This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.

Presenters:

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, MSC

Webinar Language: English

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Date and Time:

THU 30 SEP 2021, 11:00 AM - 12:30 PM Eastern US Standard Time

Description:

This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.

Presenters:

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Webinar Language: English

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