2023 US Interchange

Instructions

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Call for Abstracts

Abstracts Due: Friday, 21 April 2023

We welcome abstracts for the 2023 CDISC US Interchange on any of the topics listed below.

Conformance Rules, Validation, and CDISC Open Rules Engine (CORE):

We invite you to share your experience with the implementation of FDA, PMDA Business, and/or validation rules, CDISC (SDTM, SEND, ADaM, Define-XML) conformance rules, rules that are part of a TAUG, the integration of rules into standards governance, and the use of Open Source tools (such as CDISC CORE) when authoring or generating internal rules. What lessons can you share from these experiences?

Standards Governance, CDISC 360 and MDR – User Experiences:

We invite you to share how you have successfully adopted components of CDISC 360 or MDR, including the handling of multiple versions of standards, how adoption has affected your systems and processes, how you ensure adherence in terms of submission to one or multiple regulatory agencies, your experiences with metadata-driven governance and collected element usage, how you determine what data you aren’t using in the final CSR (to simplify collection), and your experiences with data literacy. We are looking for presentations that demonstrate experience with graph databases and/or linked data implementations, automation, implementation of USDM, and TransCelerate Digital Data Flow (DDF). What lessons can you share from these experiences?

Implementation Use Cases:

We invite you to share how you successfully implemented new features of CDISC standards and TAUGs, how you apply CDISC standards and TAUGs to other uses (such as integration or in disease areas not yet covered by TAUGs), and how you have been impacted by pandemic-related disruptions (including missing data, FDA regulations, and the need for faster submissions). How have your systems, tools, processes, and collaborations changed to work with these implementations? What lessons can you share from these experiences?

Impact of CDISC Standards on Business Optimization:

We invite you to share how you have measured and improved and efficiencies in business processes as a result of CDISC standards implementation, and the kinds of internal opportunities or external collaborations you have been able to pursue as a result of implementing CDISC standards. What lessons can you share from these experiences?

Real World Data / Evidence and Decentralized Clinical Trials:

We invite you to share your experience with incorporating RWD/RWE into drug development, implementing CDISC standards for real world data (i.e. observational study data, registry data, in academic research or public health settings), moving to decentralized clinical trials (DCTs), the use of master protocols, and the use of digital biomarkers and/or digital endpoints collected as part of the clinical trial. Do you have experience collecting genomics data as part of a clinical trial, using the Genomics Findings domain? What impact have these implementations had on your systems, processes, and development lifecycle? What obstacles and barriers have you seen, and what solutions have you found to address them? What lessons can you share from these experiences?

Artificial Intelligence (AI):

We invite you to share how implementation of Machine learning, Natural Language Processing, Computer Vision, or Optimization at your organization has benefited from the use of data standards, and how you are incorporating these experiences into drug development. What lessons can you share from these experiences?

Digitization:

Digitization is a big buzzword in clinical operations and clinical data management processes for the end-to-end tasks of CTMS process with protocol development, eCRF, direct data collection to data analysis and submissions. We invite you to share how your organization has accelerated or automated its processes through digitization? What lessons can you share from these experiences?

CDISC Fundamentals:

We invite you to share tips, tricks, and use cases on how to implement CDISC standards and how you are filling any current gaps. Experience with Analysis Results Standard is of special interest.

Talent Management:

As experienced resources retire, there is a need for the development of the next generation of data scientists. We invite you to share what your organization has done to transform standards analysts and programmers into the next generation of data scientists.

Paradigm Shift:

We invite you to share how your organization incorporates diversity, equity and inclusion data collection and analysis processes, in healthcare data and clinical trials.

CDISC in Academic Research:

We invite you to share your experiences with Healthcare Data Systems, eSource/Direct Data Capture (DDC), Meta Analysis / Data Integration, and Computer Science and Data Science perspectives on CDISC standards. What lessons can you share from these experiences?

Opportunities in Clinical Data Sharing:

We invite you to share your experiences with big data / pooling of historic R&D data and harmonizing it using CDISC standards, and data driven decision-making across the value chain. What lessons can you share from these experiences?

Regulatory Submissions:

We invite you to share how you are handling changes in submission requirements, versions of standards, and country-specific requirements, and new FDA guidance documents (such as the Standard Safety Tables and Figures). What lessons can you share from these experiences?