CDISC, HHS/ONC and FDA Issue Challenge: Regulated Clinical Research Study using EHRs
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CDISC, HHS/ONC and FDA Issue Challenge: Regulated Clinical Research Study using EHRs

Philadelphia : PA : USA | Aug 07, 2012 at 11:01 AM PDT
Source: PRWeb
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HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated clinical research during a Session on 26 June at the Annual DIA meeting in Philadelphia. Specifically, clinical research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated clinical research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated clinical research during a Session on 26 June at the Annual DIA meeting in Philadelphia. Specifically, clinical research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated clinical research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. FDA/HHS) stated that it is of interest to the regulated stakeholders to leverage EHRs...Meaningful Use initiative to increase the use of EHRs; adoption has increased from 20 to 40% in the past 2 years. He said that Stage 1 was ‘making things electronic’, Stage 2 was ‘getting the data to move’ and Stage 3 will be ‘doing interesting things with the data (or learning from the data)’. “We will have 18 months to try to understand the EHR data and how to better learn from it. Clinical Research is fundamental and we should be leveraging EHRs for this purpose,” stated Dr. Fridsma. “We look forward to seeing who will step up to this challenge.”

Since most investigators conduct one clinical research study and no more due to the cumbersome existing processes, it is time to change this scenario such that clinical research is not difficult for clinicians and we can learn more from clinical care...Vision is to inform patient care and safety through higher quality medical research.

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/8/prweb9774937.htm

 
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