2022 Europe Interchange Call for Abstracts

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Call for Abstracts

Abstracts Due: Friday, 7 January 2022

Theme: With Standards - Unlock the Power of Data!

We welcome abstracts for the 2022 CDISC Europe Interchange on any of the topics listed below, including on COVID-19. 

COVID-19 Impact 

The COVID-19 pandemic is not over yet, but what have we learned from it to be prepared for the future? How has missing data, FDA regulations, standards updates and/or the need for faster submissions impacted your systems, processes, and collaborations? What can we do better in future?

Real World Data / Evidence 

The life cycle of drug development is being modernized through the use of real-world data / evidence. The combination of RCT data (safety, efficacy) and RWD (effectiveness) for submission is becoming the 'new' standard. We are interested in receiving experiences from the industry on the following related topics: 

• Progress and barriers to the use of real-world data/evidence for regulatory evaluation
• Best practices in using CDISC Standards for RWD and barriers
• Implementing RWD to make Adaptive Pathways work
• Synthetic Control Arms
• Pragmatic Clinical Trials
• Use of CDISC and other life sciences/healthcare standards (OMOP data model, HL7 FHIR, etc.)
  • FHIR to CDISC Joint Mapping Implementation Guide v1.0
• CDISC collaborations with other standards and initiatives
• Move to Decentralized Clinical Trials - usage of digital biomarkers/digital endpoints (collected as part of the clinical trial)

CDISC Academic, Operational and Non-Regulatory Uses

CDISC in Academic Research

• Healthcare Data Systems
• eSource/Direct Data Capture (DDC)
• Meta Analysis/Data Integration

Operational CDISC

• Integrations
  • IxRS
  • Safety
• Data Marts

Conformance Rules and Validation, Including CDISC Open Rules Engine (CORE) and CDISC Open Source Alliance (COSA) 

• Implementation of FDA/PMDA Business/Validation rules vs. CDISC conformance rules
• Experience of various validation tools for SEND/SDTM/ADaM
• Handling of data issues that cannot be changed
• Rules coming as part of a TAUG
• Conformance rules integration into the standard governance
• Experience in use of Open Source tools

Global Regulatory Submissions 

• Submission to FDA/PMDA/NMPA learnings
• Submitting around the globe, submission experience with other Health Authorities e.g. Korea, EMA, DKMA
• eData consultation and Appendix 8 preparation experience from PMDA submission
• SDSP vs. PMDA Appendix 8 and how to align it with cSDRG/ADRG
• Supporting FDA BIMO Deliverables
• Achieving quality in data submission e.g.  
  • Proper documentation
  • How to correctly provide metadata in define-xml
• Impact of FDA Technical Specifications, e.g. newly released NASH

Standards Governance, MDR and CDISC 360 - User Experiences 

• 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?
• Implementation Challenges
• Graph databases/linked data implementations
• Automation experiences
• How does an MDR affect governance compared to governance without an MDR?
• How MDRs support up-versioning of SDTM/CT/ADaM

Experience with TAUGs and Implementation Use Cases

• Implementation of TAUG recommendations
• Differences (variations) between TAUGs
• Major current TAUG gaps and recommendations for future development
• Handling of extension studies or multiple enrolments
• Experiences usage of CDISC in other domains (e.g. Medical Devices, Diagnostics)
• Experience using the CDISC Library

Artificial Intelligence (AI) and Impact of CDISC Standards on Business Optimization 

• Applying AI in life sciences supporting drug development: How do we benefit from using CDISC and other data standards?
  • Includes use cases on Machine Learning, Natural Language Processing, Computer Vision and Optimization examples. 
• Applications of AI to extract value from Real World Data
• Experiences using AI with large data handling from devices/sensors, images, other(s) (deliver standards perspective)
• Regulatory and CDISC positioning on usage of AI e.g. US FDA SAMD Action Plan & Proposed Regulatory Framework
• Submission preparation and readiness
• Collaborations and cross-pharma initiatives
• Management, resourcing and new opportunities
• Meaningful realized benefits

CDISC Foundational Standards 

• CDASH/IG 1.2/2.2
  • CDASH SAE Supplement v2.0
  • CDASH Variable Naming Conventions
• SDTM/IG 2.0/3.4
  • Controlled terminology realignment
  • Specimen based Findings
  • Genomic Findings (GF)
• ADAM
  • Use of ADaM for data integration / pooling
  • How to achieve traceability in ADaM
  • Example of TA-specific endpoints application in ADaM
  • Leveraging Analysis Results Metadata 
• SEND/IG 1.5/3.1.1
• Define-XML v2.1

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

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