The US Spring Meeting, hosted by eClinical Solutions at the Patriots Stadium Conference Center near Boston, MA, was attended by members from 13 Biopharma companies, 4 CR Software Vendors, 3 CROs and 1 EHR Vendor.  Evaluations were extremely positivie and included:

"The eClinical Forum provides relevant and important industry information. I find the Forum to be better than other meetings and feel the information and knowledge sharing invaluable. I also like the networking and open discussions."  ...  "This is a very helpful meeting, more interest, more open than others. Good mix of practical talks and future trends, and opportunities for input."  ...  "Excellent -- it is a great environment to share information and collaborate with peers."  ...  "Always better than other industry groups / meetings. Thanks!"  

Meeting materials and presentations are available to members via the Members Access area of this website.

Once again the feedback and evaluations from the meeting of eClinical Forum Members was extremely positive...

"The best" ... "Very open-minded; best opportunity for networking and experience exchange; a real working group with very good achievements" ... "Excellent group - friendly, informative, great experience"

Meeting materials are available from the Members Area

 The Electonic Health Records for Clinical Research (EHRCR) Project, co-sponsored by the eClinical Forum and PhRMA EDC/eSource Task Force, announces the 2nd release of the EHRCR User Requirements Document.  This document provides a discussion of potential for healthcare and clinical research systems to evolve together.  Minimal requirements are mapped to global clinical research regulations.  These requirements are further mapped to the HL7 EHRCR Functional Profile and the EuroRec EHCR Functional Profile, both products of this team.  For more information, see www.ehrcr.org.

The Electronic Health Records for Clinical Research (EHRCR) project (sponsored by the eClinical Forum and PhRMA EDC/eSource Task Group), have released a white paper titled "Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) in Support of Clinical Research".  This paper can be downloaded from the project website:  www.ehrcr.org.  It provides practical information for those sites (and asociated research sponsors) where electronic health record systems are being used.  On 21-Jan-2010, an ACRP (Assoc of Clinical Research Professionals) webinar was held, presenting this information, with approximately 80 participants, primarily from the healthcare industry.  The paper has been widely distributed within the pharmaceutical industry as well.

This is a series of 4 “Birds-of-a-Feather” Teleconferences during 2010 to share experiences with use of CDISC standards as a follow-up to the very successful BoF on this topic in July 2009, in which the FDA participated.   Each teleconference in the series will target specific topics, chosen by the participants.  The format will be a facilitated discussion.  The FDA are invited to participate. 

Series Dates:   Jan 26 2010, April 20 2010, July 2010 TBA, Oct 2010 TBA

It is not necessary to participate in all 4 teleconferences, however it is necessary to register.  Anyone from an eCF Member Company is welcome to participate. Registrants will be given the opportunity to choose the discussion topics and will be given call-in information

The EHRCR Functional Profile project is a joint venture between eClinical Forum and PhRMA EDC/eSource Task Group.  The profile, which indicates core functionality needed in an EHRsystem in order to use electronic health records for regulated clinical research, became an HL7 Normative Standard in January 2009, and an ANSI Standard in July 2009 and was approved by EuroRec in November 2009.  It is being used as a reference for the CCHIT Clinical Research Working Group and is being presented to CEN for consideration.  This functional profile is the only approved standard in the area of electronic health records for clinical research, and is the only international EHR profile.

For more information on the EHRCR project, visit the project website at www.ehrcr.org

As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions.

The eClinical Forum is directed by a Steering Committee of 6 volunteer members, each holding a two-year term and two permanent members. At the Annual General Meetings in April (Helsinki), and May (Boston), we elected new candidates to replace members completing their terms. New members are: EU - Richard Gratton (BMS), Yvonne Rollinger (Omnicomm), US - Sharon Powel (Lilly), Greg Gogates (CRF Health), Michael Haushalter (BI).  Returning members are: EU - Eli Mudry (Roche), US - Kevin Ahonen (Biogen Idec)

Patient Reported Outcomes (PROs) are becoming increasingly important in the evaluation of the efficacy of new drug products.

In February 2006, the Food and Drug Administration (FDA) released draft Guidance to the Industry on their expectations for PROs intended to support labeling claims for new drug applications. The FDA emphasized the importance of collecting PROs in a reliable and valid manner in order for them to be used to support labeling claimsThe eCF& handbook provides guidance on implementing technology solutions to handle electronic patient reported outcomes (ePRO. This handbook brings together knowledge from ePRO experiences of eCF members and this initial release describes ePRO in general and provides a roadmap for those wanting to get started with this technology.

The EHRCR Project (co-sponsored by the eClinical Forum) has achieved a major milestone.  The HL7 version of the EHRCR functional profile, which identifies minimum requirements for data from electronic health records to be used as source for regulated clinical research, has been approved as an HL7 Normative Standard via an arduous balloting process involving HL7 members from the EHR stakeholder community.  This is the first global HL7 standard and the first that touches on the area of clinical research.  The HL7 EHRCR functional profile will now be submitted by HL7 to the American National Standards Institute (ANSI) to become an ANSI standard. 

The HL7 EHRCR will be considered as part of the 2010 work with CCHIT (US Certification Committee for Health Information Technology) on a clinical research certification for electronic health record systems. 

For more information on the EHRCR project, visit the project website at www.ehrcr.org