Please use the form below to submit your abstract for consideration. PLEASE MAKE SURE TO PRESS THE SUBMIT BUTTON AT THE BOTTOM OF THE FORM. You should receive a confirmation message after successful submission.
Abstracts Due: Friday, 25 June 2021
Theme: With Standards - Science Will Prevail!
We welcome abstracts for the 2021 CDISC US Interchange on any of the topics listed below.
How has missing data, FDA regulations, and/or the need for faster submissions impacted your systems, processes, and collaboration?
How are you handling changes in submission requirements, including versions of standards and country-specific requirements?
How have you successfully adopted components of CDISC 360 or MDR, including the handling of multiple versions of standards, and how has it affected your systems and processes?
How have you successfully implemented new features of CDISC standards and TAUGs? How are you applying CDISC standards and TAUGs to other uses, such as integration or in disease areas not yet covered by TAUGs? How have your systems and tools changed to work with these implementations?
How are you using CDISC and Regulatory Agency rules to test for conformance and submission-readiness? How are you handling data issues that can’t be changed?
How are you managing your internal suite of standards? How do you determine when to up-version, and when to stop supporting older versions? How do you track and approve requests for new standards or an exemption from using standards? How do you ensure standards are being followed?
How have you improved and measured efficiencies in business processes as a result of CDISC standards implementation? What kinds of internal opportunities or external collaborations were you able to pursue as a result of CDISC standards?
How have you incorporated RWD/RWE into drug development? What impact has this had on your systems and processes? What lessons have you learned from previous pilots or submissions?
How has implementation of Machine learning, Natural Language Processing, Computer Vision, or Optimization at your organization benefited from the use of data standards? How are you incorporating this into drug development?
What tips, tricks, and use cases can you share on how to implement CDISC standards? What are current gaps, and how do you recommend filling them?
You are welcome to submit an abstract on any CDISC experience, implementation or planning-related topic. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned. CDISC is an open and multidisciplinary standard which interfaces with many areas, and we are eager to hear about your experiences working with standards.
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WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION!
If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at firstname.lastname@example.org.