SUBMIT YOUR ABSTRACT
DIA invites you to submit a presentation abstract for the 23rd DIA Japan Annual Workshop for Clinical Data Management, to be held in Tokyo on February 5-6, 2020.
Calling Abstracts: Flyer is here
We are calling for abstracts that show a practical example and/or case-study in the following fields:
Data Quality Management from Risk-Based Approach (RBA): Data quality check from RBA perspective, or Risk-Based Monitoring (RBM) data management challenges
Real World Data (RWD): Examples of database research, registry data management, and data usage
CDISC Implementation and eData submission: eData submission and CDISC implementation challenges
Investigator-Led Clinical Trials: Data management considerations for Investigator-Led Clinical Trials
eSource and Patient Technology: Electronic reported clinical outcome assessments (eCOAs), mHealth or “Smart” Trials, Electronic Health Record interoperability
Education: CDM education and training
Submission Deadline: Friday, August 30, 2019 (Japan time)
Notification: by September 27, 2019
All abstracts have to be submitted online at DIAglobal.org/Abstracts
Please read additional information on the Abstracts Details.
Questions? Contact Japan@DIAglobal.org
Advanced technology such as artificial intelligence, robotics, and natural language processing is penetrating and spreading healthcare product development, while use of eSource and digital devices supports digital data flow and suggests a new clinical trial methodology. Standardization to CDISC is envisioned by 2020 upon full implementation of eData submission, and, combined with the Common Protocol Template proposal, is also helping to lead the standardization and digitalization of end-to-end data flow.
Investigator-initiated trials and collaboration between academia and industry continue to increase as advanced and translational medical technologies such as regenerative and genetic medicine are more deeply incorporated into medical practice in Japan. The impact of these advanced technologies on approaches to drug and device development remains undetermined.
Are clinical data managers (CDMs) ready to ensure the quality of their data through Quality by Design (QbD) as ICH E6(R2) and E8 are being implemented and the “GCP Revolution” is openly discussed? What actions must CDMs take to extend the Risk-Based Approach from clinical trial design to clinical trial reporting and beyond, to post-market safety monitoring?
Our overall theme Next Generation Data Managers– Let’s enjoy changes and adventures. We will discuss how CDMs can display leadership to manage sufficient data quality and enhance data reliability, reflecting the fact that the range of clinical trial data sources and types keep growing broader, for the next generation to follow. reflects the fact the range of clinical trial types and data sources are rapidly expanding. We will collaboratively discuss how CDMs can enhance data reliability and utilization for various clinical trial designs and data sources throughout the drug and/or device product lifecycle, including post-market monitoring. It aims to improve the quality of both clinical research and clinical data management in Japan, and will provide numerous opportunities for networking and information exchange among industry, government, and academia.