2024 US + TMF Interchange Call for Abstracts - CDISC Abstracts

Instructions

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 see a confirmation page after successful submission.

2024 US + TMF Interchange Call for Abstracts - CDISC Abstracts

Abstracts Due: Friday, 26 April 2024

We welcome abstracts for the 2024 US + TMF Interchange on any of the CDISC topics listed below.

 

Health Equity use cases for new and updated data standards:

  • SOGI Roadmap including Lab Data and new forms for organ inventory, Disability Form, RACE/ETHNICITY
  • We invite you to share how your organization incorporates diversity, equity and inclusion data collection and analysis processes, in healthcare data and clinical trials.
  • History of RACE/ETHNICITY Census data and its impacts on Standardizing healthcare and research data.

Talent Management

As the drug development patterns have changed from traditional products to ADC (antibody Drug Conjugates in cancer, Protein degradation mechanisms(cancer), GLP-1s in weight loss and metabolic Syndrome areas, personal and precision medicine (Cancer Vaccine areas), Biomarker testing and Translational medicine (early testing areas of clinical sciences), there is a need for empowerment and enhancement of basic scientific knowledge to Clinical Programmers and data scientists, who traditionally comes from Engg, computer science and other areas of arts to better fulfillment of CSR and protocol write-ups and understanding and eCRF designs, write way of data collections and curation of data standards for submission. Therefore, empowerment of scientific knowledge to programmers and data scientists is going to another topic for submissions and thereby approvals.

Novelty in Clinical Trials and CDISC Standards

  • Modernization of clinical trial impact on CDISC standards: decentralized trials incl. digital endpoints, master protocols, patient and rare disease registries.
  • Applications of AI to extract value from Clinical Trials and Real World Data
  • Regulatory and CDISC positioning on usage of AI

Real World Data / Evidence

  • Experiences of RWD/RWE in regulatory decision-making for drugs and biologics
  • Use of CDISC and other industry standards (OMOP data model, HL7 FHIR, etc.) incl. conversions between standards
  • Regulatory guidance, progress and barriers

Open Source usage, including CORE, OAK, ARS, COSMoS

  • Experience in the use of CORE, Rules Authoring Tool and generation of Rules
  • Experience of various validation tools for SEND/SDTM/ADaM/Define
  • Experience in use of Open Source tools
  • Implementation examples of ARS

Digital Data Flow

  • Implementation examples of DDF
  • Extensions to DDF
  • DDF impact on drug development
  • DDF and integration with upstream and downstream process: challenges and advantages

Standards governance and MDRs

  • Managing CDISC versions and handling (non) adherence in terms of submission to one or multiple regulatory agencies
  • Metadata-driven governance and automation experiences
  • How to ensure end to end connections between different CDISC standards: CDASH-SDTM-ADaM
  • Pharma/Bio tech experiences with graph databases/linked data implementations

CDISC Foundational Standards

  • CDASHIG 2.3/3.0
    • Sexual Orientation & Gender Identity (SOGI)
  • SDTM/IG 2.2/4.0
    • Preparing for SUPP to NSV Transition
  • ADAM 3.0/1.4
  • SEND/IG 2.2/4.0
  • Define-XML v2.1
    • upversioning from 2.0 experience
  • CT domain changes

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?

  • Submission to FDA/PMDA/NMPA learnings
  • Submitting around the Globe, submission experience with other Health Authorities e.g. EMA Clinical Trials Raw Data Pilot
  • Supporting FDA BIMO Deliverables
  • Achieving quality and efficiency in data submission e.g.
    • Proper documentation
    • How to correctly provide metadata in define-xml
    • Automation
    • Process flow
  • Impact of new FDA guidance e.g.
    • Standard Safety Tables and Figures Guide
    • Experience and adherence to FDA division guidance e.g., CBER Vaccine, CDER NASH, etc.
    • Inclusion and diversity requirements and challenges from standards point of view e. g. Gender How to correctly provide metadata in define-xml
    • RWE impacts decision making by regulators – opportunities and challenges from data standards/harmonization/review
  • Experience integrating data from multiple studies in support of Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE)
  • Imagine Data Submission in 2041: how technology, standards and industry initiative can fasten data submission

OTHER CDISC STANDARDS TOPICS

You are welcome to submit an abstract on any CDISC model experience, its implementation and associated planning. 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.

Contact Information
Please include your mobile phone number where you can be reached, in case we're unable to contact you by email. 
Abstract Submission
General Topic

Upload paper (not required).

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.
  1. All author(s) approve submitting this work for presentation.
  2. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation.
  3. The presenting author will be available to present the abstract in person in Scottsdale, AZ if selected for the program. The presenting author will immediately notify CDISC if they are unable to present an abstract or if the presenting author changes.
  4. Submission of the contact details provided are those of the presenter of the abstract. The primary author will be notified about the status of the abstract and is responsible for informing the other authors about the status of the abstract.
  5. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  6. Submission of the abstract constitutes consent of all authors that CDISC will make presentation(s) and paper(s) available online, whether in video or PDF format, to the conference attendees, and after six (6) months, to the CDISC member community.

WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION!

Questions?

If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at events@cdisc.org.

I confirm that I am submitting this abstract as CDISC content for the US Interchange.