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Practical Considerations for use of Certified EHRs for Clinical Research V1.0

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 The EHRCR Project (sponsored by the eClinical Forum) announces the document release:

 Practical Considerations for Clinical Trial Sites usingElectronic Health Records (EHRs)Certified for Clinical ResearchAddressing Regulatory ConsiderationsRelease 1.0 June, 2011
This is the first paper of its kind, speaking directly to clinical research investigative sites regarding the use of electronic health record systems.  It is based on clinical research regulations and guidances and includes a checklist for sites to assess how their systems (whether certified or not), and their processes comply. 

The EHRCR Project is comprised of members from pharmaceutical sponsors, CROs, software vendors (both CR and EHR), and has included regulatory review.  They have produced an EHRCR Functional Profile which is now an ANSI/HL7 standard, approved by EuroRec, and is currently under consideration to become a CEN/ISO standard.  The profile (a) is founded on current clinical research regulations / guidances, (b) translates requirements into measurable criteria to assess suitability of a system for clinical research, and (c) was used as a input for the recently released CCHIT Certified® 2011 Clinical Research certification option for Ambulatory EHRs.  



File size 386 K
Downloads 118
Date Wed 06/01/2011 @ 10:56
Author EHRCR Project Team
EMail info@eclinicalforum.org

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2010 Accomplishments and 2011 Goals

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2010 Accomplishments and 2011 Goals

File size 113 K
Downloads 19
Date Thu 03/03/2011 @ 10:56
Author eClinical Forum EHRCR
EMail

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Response Letter - Mar 2010

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Comments on HHS 45 CFR 170: Health Information Technology; Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology

File size 42 K
Downloads 9
Date Mon 03/01/2010 @ 10:56
Author eClinical Forum EHRCR
EMail

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EuroRec Electronic Health Records - Feb 2010

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The document describes a Functional Profile that identifies critical capabilities for the conduct of regulated clinical research utilizing EHR systems. Further to conforming to the EuroRec Repository Profiling Tools, this Profile identifies additional functionalities toward facilitating ease of use for those involved in clinical research.

File size 369 K
Downloads 20
Date Tue 02/02/2010 @ 10:56
Author eClinical Forum EHRCR
EMail

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EHRCR Webinar QA - Feb 2010

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Practical Considerations for Clinical Trial Sites using Electronic Healthcare Records (EHRs) in Support of Clinical Research QA Session

File size 25 K
Downloads 10
Date Mon 02/01/2010 @ 10:56
Author eClinical Forum EHRCR
EMail

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Connecting Healthcare & Clinical Research

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Connecting Healthcare and Clinical Research

The EHR for Clinical Resaerch Functional Profile Project



File size 1663 K
Downloads 26
Date Fri 01/01/2010 @ 10:56
Author eClinical Forum EHRCR
EMail

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Practical Considerations using EHRs - Jan 2010

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The eClinical Forum and PhRMA EDC/eSource Taskforce Document on Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) in support of
Clinical Research


File size 335 K
Downloads 16
Date Fri 01/01/2010 @ 10:56
Author eClinical Forum EHRCR
EMail

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EHRCR User Requirements Release 2 - Jan 2010

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This User Requirements document clarifies the minimum requirements to use healthcare systems as the data source for regulated clinical research1 today, in order to ensure the reliability of clinical research data from EHR (Electronic Health Record) systems.

File size 1158 K
Downloads 11
Date Fri 01/01/2010 @ 10:56
Author eClinical Forum EHRCR
EMail

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HL7 Announcement - Nov 2009

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Profile approval announcement

File size 35 K
Downloads 9
Date Sun 11/01/2009 @ 10:56
Author eClinical Forum EHRCR
EMail

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ANSI/HL7 EHR CRFP, Release 1-2009

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File size 2280 K
Downloads 18
Date Mon 07/20/2009 @ 10:56
Author eCF
EMail

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