Unlocking a Global Language for Smarter Research
The opportunity to transform clinical research is at our fingertips with new technologies and global standards available. Still, we continue to struggle with a number of research-related activities that prevent efficient and effective learning from evidence generated through research or healthcare.
CDISC standards support research, from protocol development and trial registration, to patient-level data collection and data aggregation across patients to tabulation, to analysis and publication or regulatory submissions. Starting in late 2016, CDISC standards for data tabulations and analysis datasets will be required by FDA and Japan’s PMDA for aggregated patient data submitted to support the approval of new biopharmaceutical products.
This Symposium will provide an overview of CDISC and its suite of harmonized and curated standards for clinical research. These standards are available electronically via the Shared Health and Research Electronic Library (SHARE), CDISC’s metadata repository. In terms of data quality and ROI, the value of using CDISC standards from the start of a research study will be discussed. Details on the process for developing TA standards and information on how researchers can actively participate in the development stages and/or the comment periods will also be provided.
This Symposium is recommended for clinicians, clinical researchers and scientific investigators interested in ways to represent clinical research data to accelerate study start-up, enhance the value of research data and streamline research processes.