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

 Practical Considerations for Clinical Trial Sites using

Electronic Health Records (EHRs)

Certified for Clinical Research

Addressing Regulatory Considerations

Release 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.  (For more information on the EHRCR Project:  www.ehrcr.org )

Please complete registration and send to suzannekbishop@gmail.com

Leveraging EHR data to improve protocol designs, avoid protocol amendments, avoid site closures and enhance patient recruitment - Informa Conference Brussels 25th May 2011

Please download to review the comments.