2020 U.S. Interchange: Call for Abstracts

Update: Call for Abstracts Extended! 

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.

Call for Abstracts

Abstracts Due: Friday, 24 July 2020

Theme: Driven by Standards. Powered by Technology.

We welcome abstracts for the 2020 CDISC US Interchange on any of the topics listed below, including on COVID-19. For any of the topics listed, if you have an interesting perspective based upon your experience during the time of COVID-19, this would be of great interest.

COVID-19 Impact

• Implementation of FDA regulatory guidance
  • Handling missing data, and analysis – how do standards help with this
  • Protocol deviations, drug accountability, remote visits, adverse events, etc.
• CDISC COVID-19 Interim User Guide – CDISC & External
• Collaboration between organizations (on user guide and external)
• Streamlining the standards development process (CDISC & external)
• Impact on systems, processes, existing studies – creativity during this time (change management)
• Importance of standards in pulling things back from paper (QRS)
• Compassionate use data; expanded access
• The future of clinical research in relationship to infectious disease, how has COVID-19 changed how you work?

Global Regulatory Submissions

• Submission to FDA/PMDA learnings
• Submitting CDISC to NMPA (China Authority)
• eData consultation and Appendix 8 preparation experience from PMDA submission
• SDSP vs Appendix 8 and how to align it with cSDRG/ADRG
• Achieving quality in data submission e.g.
  • proper documentation,
  • how to correctly provide metadata in define-xml

MDR session

• Implementation Challenges
• Experiences in operational use
• Automation experiences
• KPIs available?
• How does an MDR affect governance compared to governance without an MDR
• How MDR support upversioning of SDTM/CT/ADaM
• Biomedical concepts/RDF/Graph data based MDR's use case on end to end implementation
• CDISC Library -First experiences Using the Library API & Tools

Implementation Use Cases

Examples:

• Handling of USUBJID creation (update), Screen Failures (update), extension studies, RACE (add. RACE categories), Protocol Versions; Protocol Deviations in SDTM and ADaM
• How and what to annotate on aCRF
• Data Integration
• Findings About usage
• Associated Person
• Experiences usage of CDISC in other domains (Medical Devices)

Network and break-out session

• Opportunity for an open dialogue between conference participants to further discuss agenda topics, e.g. MDR, Rules and Tools, standards governance,…
• Invitation to software vendors to show the end-to-end implementation of the library (15 minutes). Demonstrate the following:

• creation of an eCRF
• annotation of a CRF
• creation of SDTM data
• creation of ADaM data
• creation of Define-XML
• proof of traceability
• full implementation of the CDISC Library

Rules and tools

• Implementation of FDA Business/Validation rules vs CDISC conformance rules
• Experience of various validation tools for SEND/SDTM/ADaM
• FDA's technical rejection criteria, PMDA reject severity rules
• Mandatory rules coming as part of a TAUG / Standard deliverables packages

End-to-End / CDISC 360 updates 

• Use case of MACE endpoints for FDA's safety analysis
• Implementation of the CDISC Library from a user perspective
• Experiences / progress from the CDISC 360 working group

Standards governance

• How to handle CDISC versions before submission/across standards
• How do you handle non-adherence in terms of submission?
• How do you ensure adherence?
• Metadata-driven governance. Collected element usage. How do you determine what data you aren’t using in the final CSR, in order to simplify collection?

Experience with TAUGs

• Implementation of TAUG recommendations
• Differences (Variations) between TAUGs

Efficiency of standards usage / Management KPIs 

• Impact on timelines in operational use
• Impact on timelines in downstream processes
• Available KPIs and realized benefits
• Impact on Submission readiness

Real World Data / Evidence

• The Life cycle of drug development is being modernized through the use of real-world data and real-world evidence. 
• We are interested to receive experiences from the industry on the following related topics: 
  • CDISC Standards and OMOP Common Data Model
  • CDISC Standards and HL7 FHIR
  • Progress and barriers to the use of real-world evidence for regulatory evaluation
  • Pragmatic Clinical Trials (or large simple trials)
  • Adaptive Approval Pathway experiences and usage of CDISC 

Medical Devices 

• Regulatory and CDISC news and updates
• Updates and changes over the years
• Experience in CDISC submission for medical devices
• How to apply the model for different kind of medical devices                              

CDISC Core 

• SDTM IG 3.3/3.4
• DefineXML v2.1
• CDASHIG 2.1, Model 1.1 and new CRF Metadata
• ADAM
  • Use of ADaM for data integration / pooling
  • Application of Imputation Methods in ADaM
  • How to achieve traceability in ADaM
  • Example of TA-specific endpoints application in ADaM
• Updates on LOINC and UCUM
• Code list changes
• Foundational Standards tips and tricks
• Current Gaps

Artificial Intelligence (AI) / Mobile devices 

• Machine learning (ML), computer vision, natural language processing, optimizations - Requests for practical examples
• Use of CDISC standards in Data Warehouse / Repository environments
• Experiences with massive data handling sourced from many devices under the umbrella of data standards
• Applying (deep) Machine Learning and AI in Life Sciences supporting Drug Development: Do we benefit from using Data Standards ?
• Regulatory and CDISC positions handling multiple devices / eSources
• FDA and the usage of "Software as Medical Device"                                                                                                                        

CDISC standards usage in academia 

• Use of the CDISC and other life sciences and healthcare standards in an academic environment
• Collaborations between academia, CROs and pharma                                                                          

Open Source implementations of solutions related to CDISC 

• Available CDISC tools
• ML / AI implementations using Open Source solutions
• Tools / Code examples to support CDISC artifacts consistency
  • ex.: code to validate external links from define.xml (CRF page, external documents presence etc)

Outcome from user or working groups 

• Does your user or working group have a great achievement you would like to present at the conference?

OTHER TOPICS TOWARDS CDISC STANDARDS

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 interface with many areas and we are eager to hear about your experiences working with standards.

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

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