Home / 2019 CDISC Japan Interchange - Call for Abstracts

Invitation to Submit an Abstract


You are invited to submit an abstract for the 2019 CDISC Japan Interchange on your experience with CDISC standards, models, implementation and the associated planning and/or related use cases.


CDISC standards are open and multidisciplinary and they interface and support all stages of the clinical data lifecycle.  We are eager to hear about your practical and operational experience in implementing the CDISC standards.


Deadline: 28 February 2019

Following are a number of session topics and ideas for presentations that we think would be of interest to conference attendees:


Session Topics and Presentations Suggestions


LINKING TO OTHER STANDARDS, DICTIONARIES AND FRAMEWORKS

  • Pre/Post Coordinating Controlled Terminology, or other topics related to CT
  • Use of LOINC in clinical studies – practical experiences
  • Standardized Lab Units – practical experiences
  • Migration from WHO-Drug B2 to B3 format – Impact and Implementation strategies
  • HL7 FHIR and CDISC Standards – practical experience
  • CDISC usage in IMI and Data Sharing Projects
  • Use of CDISC standards for Clinical Data Transparency


IMPLEMENTATION: Validation and Analysis (ADaM)

  • ADaM 1.2, ADaM Integration
  • PK Analysis and ADaM Traceability Examples
  • ADaM best practices
    • ADaM for data integration
    • End to End from Analysis Results Metadata to ADaM datasets
    • Therapeutic Area Experience with ADaM i.e. specificity of ADaM development in oncology
    • Achieving traceability in ADaM
  • ADaM Conformance Rules
  • Analytics and quality data review and fraud detection in the Clinical Research Domain using CDISC standards
    • Risk Based Monitoring
    • Centralized / Statistical Monitoring of clinical data
    •  Visual/Predictive analytics and Data warehousing tools/platforms


IMPLEMENTATION: Organization

  • Dos and don’ts in a submission.
  • Experience in the integration of CDISC guidelines and available white papers/recommendations.
  • Detailing the application, successes and challenges of the CDISC PGx 1.0 supplement to SDTM
  • Medical Devices
  • CDISC Implementation from a manager’s perspective
    • ROI, Benefits, Costs, etc.


IMPLEMENTATION:  Therapeutic Area Standards

  • Application of TAUGs in your organization e.g. data governance: overlap, repetition and other cross TA challenges
  • Experience with TAUGs application for submission (e.g. FDA)
  • Associated Persons
  • Biomarker / PGx
    • Genetic, transcriptomic and proteomics biomarkers of disease, including panels
    • Microbiome and microbiological molecular research
    • Biospecimen handling, processing and maintenance
  • PK Studies 


IMPLEMENTATION: Preclinical (SEND)

  • Implementing SEND challenges and solutions
  • Details of Real-World Implementations of SEND
  • Successes and challenges of using the SEND Standard
  • Updates from the SEND Team
  • Inter-organizational collaboration on SEND, i.e. CRO and Sponsor


IMPLEMENTATION: Tooling and Define-XML

  • ODM 2.0
  • Define.xml
  • SHARE 2.0 and SHARE API
  • Experiences with tools like CRF maker, Spec Grabber, SDTM Maker


IMPLEMENTATION: CDISC and Real-World Data (Observational/Post Marketing Studies (CDISC for new purposes)):

  • Value of Standardization for real world data (RWD)
  • eSource:
    • Regulatory Requirements on standardization of eSource and/or mHealth in clinical trials
    • user stories from projects like EHR2EDC and the impact on CDISC standards
    • use of data standards when working with streaming data from sensors / wearables
  • Extended use of SDTM structured data in non-interventional studies (NIS) or post-marketing studies (PMS) or Practical use of CDISC standards in NIS and PMS


TOWARDS END TO END AUTOMATION: Data Warehousing, Artificial Intelligence and Machine Learning

  • End-to-end (E2E) implementation: experience in setting up and improving internal processes.
  • Machine learning, computer vision, natural language processing, optimizations - Request for practical examples
  • Use of CDISC standards in Data Warehouse / Repository environments
  • Share experience about a specific CDISC standard/item implementation.
  • Semantics and SHARE: Define-XML 2.1, SHARE 2.0 and SHARE API, ODMv2


Data Standards Governance

  • Setting up a data standards team and implementing standards
  • Data standards governance: versioning, updating, retiring and process automation
  • Data standards project management: ticketing, workflows and KPIs
  • Cross Team Collaborations: Metadata Submission Guidelines 2.0
  • The benefits and challenges of an annual release cycle.


TOWARDS PROTOCOL STANDARDS

  • Protocol Representation in machine-readable format
  • Common protocol Template in practice
  • Business Case for Protocol Representation Model (PRM)
  • Linkage between PRM and eCRF/eDC (beginning to end) in practice


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.


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