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Webinars

Webinars address industry hot topics, along 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, 17 MAY 2018, 10:00 AM - 11:30 AM Central Standard Time

Description

Beginning-to-end CDISC standards requires establishing an interoperable protocol to begin the process of automated conduct of a clinical trial.  A key feature of this interoperability is unambiguous semantics for concepts commonly presented within the protocol.  The Protocol Entities terminology effort seeks to standardize commonly used protocol concepts, while ensuring harmonization across existing CDISC terminology standards.

Learn about a new approach to modeling the terms that have been adopted to support the many complex relationships inherent in protocol terminology, which may better support the adoption of a metadata-driven research environment.  This novel approach groups related terms, or 'attributes', and associates them under a higher level 'entity'. This entity-attribute model will provide context for concept definitions and a framework on how to make semantic choices in pre-coordination versus post-coordination of protocol concepts. The protocol entities terminology team is also making use of the CDISC SHARE ecosystem in the development of these protocol concepts.  

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

  • Melissa Cook, Protocol Entities Team Co-Lead, CDISC (Volunteer) 
  • Bill Lander, Director of Clinical Innovation and Digital Platforms, GSK
  • Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute 

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


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

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