3: EHR/HIT Integration
Facilitate the integration with Electronic Health Record (EHR) / Health Information Technology (HIT) Other Information:
CDISC and other opinion leaders envision that the future of clinical data capture will be integrated into the broader world
of healthcare information technology and the EHR. This integration will have a profound impact by: - Improving a sponsor's
ability to recruit patients into trials - Enhancing accessibility to data for research - Streamlining the data capture process
by reducing data entry and transcription errors while reducing associated costs/resources to resolve such discrepancies -
Improving pharmacovigilance - Facilitating decision support - Decreasing the number of systems required at an investigator
site An equally relevant issue is the ability of clinicians to provide care that is evidencebased and predicated on safety
where knowledge can be derived from medical databases. As part of this vision, CDISC expects to take a leading role on behalf
of the medical research industry by linking biomedical research and healthcare standards efforts. This will require continued
involvement by CDISC and its Board in worldwide healthcare IT initiatives, at the technical and political levels. CDISC has
been actively engaged with the pharmaceutical industry and Integrating the Healthcare Enterprise (IHE) and various HIT initiatives
operated through the Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) in an effort to
identify how data can be harvested from the EHR for safety and medical research. This work promises to bring about process
improvements and contribute to the aggregation of data for safety reporting, signal detection and evaluation, including but
not limited to comparative effectiveness and to streamlining biomedical research processes.
Objective(s):
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