2023 Korea Interchange Call for Abstracts

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Abstracts Due: Friday, 25 August 2023

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

How modernization of clinical trials is impacting CDISC standards: experience from decentralized trials, master protocols, etc.
Social evolution can impact clinical trials conduct and standards: share experience or initiative related to this (e.g. diversity inclusion)

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 to receive experiences from the industry on the following related topics:
- Sports Medicine study like ACSM + CDISC
- Digital Medicine studies
- Progress and barriers to the use of real-world data / evidence for regulatory evaluation
- Best Practices of using CDISC Standards for RWD and Barriers
- 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)

Implementation of FDA / PMDA Business / Validation rules vs. CDISC conformance rules
Experience of various validation tools for SEND / SDTM / ADaM / Define-XML
Rules coming as part of a TAUG
Conformance rules integration into the standard governance
Experience in use of Open Source tools
Experience in the use of CORE, Rules Authoring Tool and generation of Rules

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 a 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

How to handle CDISC versions before submission / across standards / regulatory agency requirements
How do you handle non-adherence in terms of submission to one or multiple regulatory agencies, 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?
Graph databases / linked data implementations
Automation experiences
Implementation of USDM / Transcelerate DDF

CDASHIG 2.3/3.0
SDTM/IG 2.1/4.0
- SDTM/IG 1.7/3.3 Upversioning Experience
ADAM
- ADaM Metadata Submission Guidelines 1.0
- ADaM popPK Implementation Guide 1.0
- Analysis Results Standard v1.0
- Advanced use cases
SEND/IG 2.1/3.2
Define-XML v2.1
TAUG