The Clinical Data Interchange Standards Consortium
(CDISC) is pleased to announce its collaboration with
DIA
and
Integrating the Healthcare Enterprise
(IHE) to bring a demonstration of the implementation of electronic health records (EHRs) to streamline medical research. This process represents a simple yet powerful means towards shortening the current 17 year gap in translating research results into clinical care decisions.
“CDISC has been a leader in demonstrating the value of EHRs in the research arena,” stated Dr. Doug Fridsma, Director, Office of Interoperability & Standards at the U.S. HHS Office of the National Coordinator for Health IT (ONC). “Linking clinical care with clinical research sets the stage for novel ways of leveraging patient care information using more granular metadata approaches.”
The currently available solution is being demonstrated by EHR vendors along with clinical trial technology and service providers, CDISC and HIMSS at DIA 2011 in Chicago on June 19-23.
DIA 2011 provides educational and networking opportunities to more than 8,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products.
“We are very pleased to partner with DIA and CDISC to feature the profiles from the Quality Research and Public Health domain of IHE. This is a valuable opportunity to share the HIMSS Interoperability ShowcaseTM with research stakeholders,” said H. Stephen Lieber, CAE, HIMSS President and CEO of HIMSS.
CDISC has been working with the IHE Committee on Quality Research and Public Health (QRPH) for the past 7 years to develop the necessary integration profiles to implement global standards such as CDISC and HL7. The ANSI-sponsored Interoperability Specification (IS # 158), which provides a core standard research dataset from EHRs, was ratified by the Health Information Technology Standards Panel (HITSP) in 2010. The development of this IS was conducted in a manner to ensure compliance with regulatory requirements for electronic source data, electronic record retention, patient privacy and data security, audit trails and the global Good Clinical Practices (GCP). The concept behind this standards-based innovation is that data should be entered once for multiple purposes, thus improving quality and patient safety along with streamlining workflow such that a busy clinician can readily participate in research.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.