2021 U.S. Interchange: Call for Abstracts

Instructions

Call for Abstracts 

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, 19 March 2021

Theme: With Standards - Science Will Prevail!

We welcome abstracts for the 2021 CDISC US Interchange on any of the topics listed below.

COVID-19 Impact 

How has missing data, FDA regulations, and/or the need for faster submissions impacted your systems, processes, and collaboration?

Regulatory Submissions 

How are you handling changes in submission requirements, including versions of standards and country-specific requirements?

CDISC 360 and MDR

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?

Implementation Use Cases

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?

Conformance Rules and Validation 

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?

Standards Governance 

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?

Impact of CDISC Standards on Business Optimization 

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?

Real World Data / Evidence 

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?

Artificial Intelligence (AI) 

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?

CDISC Fundamentals

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?

Other Topics Relating to CDISC Standards

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.

This document has been edited with the free version of the instant HTML edior. Try it here and use it every time for your projects.

Contact Information
Abstract Submission
General Topic

Upload paper (a draft paper or outline is acceptable).

After uploading, you MUST also hit the "Submit" button at the bottom of the form to submit your abstract.

One file only.
30 MB limit.
Allowed types: pdf, doc, docx.