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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, 5 MAR 2019, 10:00 AM - 11:30 AM Central US Standard Time | 4:00 PM - 5:30 PM (GMT London Time)

Description:

This webinar will introduce the SENDIG-Animal Rule to the CDISC community for Public Review. The SENDIG-Animal Rule v1.0 is based on the SDTM v1.8 and is intended to be used in conjunction with the SENDIG v3.1 for data being submitted to the US Food & Drug Administration (FDA) under the Animal Rule. The regulations commonly known as the Animal Rule (AR) provide a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.

Under the AR, efficacy is established based on adequate and well-controlled studies in animal models of the human disease or condition of interest, and safety is evaluated under the pre-existing requirements for drugs and biological products. Like other implementation guides based on the SDTM, the SENDIG-AR is intended to guide the organization, structure, and format of standard tabulation datasets. The webinar will also address changes in SDTM v1.8 that are relevant to the SENDIG-AR.

Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research. We invite you to contribute your expertise.

Presenter: 

  • Fred Wood, VP, Consulting Services, Data Standards Consulting Group

Webinar Language: English

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Date and Time:

TUE, 12 MAR 2019, 10:00 AM - 10:30 AM Central US Standard Time | 3:00 PM - 3:30 PM (GMT London Time)

Description:

This public webinar will share results from the Scoping Process in the development of a standard for Exercise and Prevention in Type 1 Diabetes. Scoping is part of the CDISC Standards Development Process to ensure the project is well defined with clear and achievable requirements and goals. The process typically includes background research, building a list of requirements, checking regulatory requirements and conducting a search of public databases to assess the most important clinical concepts and reduce duplication of effort. Next steps will be concept modelling and standards development.

With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC will extend already published diabetes standards to develop machine-readable metadata in the following Diabetes focus areas: Pediatrics, Devices, Prevention, and Exercise.

Presenter: 

  • John Owen, Consultant Project Manager

Webinar Language: English

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Date and Time:

THU, 18 APR 2019, 10:00 AM - 11:30 AM Central US Standard Time | 4:00 pm - 5:30 PM (London)

Description:

This webinar will highlight the changes in version 1.2 of the ADaM Implementation Guide, which is scheduled to be published this year. Changes include important clarifications to existing text, standard nomenclature for stratification variables within ADSL, and a recommended approach for bi-directional toxicity grades. We will also discuss the removal of PARQUAL, which had been included in the document when it went out for Public Review.

Additionally, the webinar will discuss ADaM Integration, which supplements the published ADaM standards and presents general considerations for integration, along with standard structures for integrating ADaM Subject-Level Analysis Dataset (ADSL), Occurrence Data Structure (OCCDS), and Basic Data Structure (BDS). Similar to study-level ADaM datasets, integrated ADaM datasets are designed to meet analysis needs.

Presenters:

  • Brian Harris, Director of Biometrics Operations, MedImmune (AstraZeneca)
  • Terek Peterson, Senior Director of Global Statistical Standards, Chiltern

Webinar Language: English

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