SUBMIT YOUR ABSTRACT
DIA invites you to submit a presentation abstract for the 25th DIA Japan Annual Workshop for Clinical Data Management, to be held online on March 2-3, 2022.
Call for Abstracts: Flyer is here
We are calling for abstracts that show a practical example and/or case-study in the following:
Data quality management from Risk-based Approach (RBA): Examples of data quality check from RBA perspectives or data management challenges in Risk Based Monitoring (RBM)
eSource and patient technology: Experience of eCOA, Smart Trial, mHealth trials, or Electronic Health Record interoperability
DM best practice challenges and training initiatives
Investigator-Led Clinical Trials: Consideration and practices related to DM work, etc.
CDISC Implementation and eData submission: Examples of e-Data submission and data standardization challenge
Real World Data (RWD): Examples of database research, registry data management, and data usage
Submission Deadline Postponed: Friday, September 24, 2021 (Japan time)
Notification of results Postponed: by October 22, 2021
All abstracts must be submitted online at DIAglobal.org/Abstracts
Please read additional information on the Abstracts Details.
Questions? Contact Japan@DIAglobal.org
PROGRAM OVERVIEW
This workshop, which is DIA Japan’s longest running event, celebrates its 25th anniversary in 2022. In this quarter century, we have actively incorporated the needs of the era and the challenges of the future in order to respond to the rapid changes in the clinical development environment, while we have continued to define what Clinical Data Managers (CDM) should do and what skill sets we need through our activities in industry, government, and academia and through our interactions with overseas speakers and patients. Recently, the implementation of "Data Management" has been revolutionary, including the complexity of test design, the diversification of data to be handled (including RWD, PHR, etc.), the advancement of technology, the digital utilization of DTx and De-centralized Clinical Trials in treatment and clinical trials, and the increasing importance of academic CDMs such as clinical research and registry utilization.
The impact of the COVID-19 Pandemic on clinical sites, flexible response, and decision-making, as well as the promotion of innovative methods, has given us an opportunity to realize again the importance of cross-role, purpose-oriented collaboration and communication.
On the other hand, there have been many changes in regulatory trends. In March 2021, the "Basic Concepts on Use of Registries in Approval Application" was announced. This is expected to promote the utilization of real-world data acquired under actual medical conditions. Further, in August 2020, the Revision of the Ministerial Ordinance on Good Clinical Practice for Medical Products was issued, which serves as reference to ensure smooth implementation of clinical trials. Meanwhile, the New Ethical Guidelines on Life Science and Medical Research for Human Beings was issued in March 2021, ensuring subject protection, science and reliability is always paramount.
This 25th anniversary edition of the CDM Workshop will bring together industry, government, academia and beyond to discuss the value and future of data in clinical development for people in need of new treatment.
This workshop aims to improve the quality of clinical research and clinical data management activities. We will also provide opportunities for networking and information exchange beyond industry, government, and academia.
