EHR/CR Profile
Future EHR/eSource Paper
EMR Survey
ePRO Handbook
Birds-of-a-Feather Telecons
SAE/AE Best Practices
In addition to our Spring and Autumn meetings in both Europe and the US, the following activities are ongoing:
EHR Profile for Clinical Research – The Electronic Health Records for Clinical Research (EHRCR) Profile team has produced a minimal set of functions and criteria needed in order for EHR systems to be qualified for use as a source of data for clinical research. The EHRCR Profile team (co-sponsored by eClinical Forum and PhRMA EDC/eSource Task Force) is the first international team working with the HL7 EHR-S Functional Model and is additionally collaborating with EuroRec as well as clinical research and healthcare groups. The team has taken an in-depth look at the HL7 and EuroRec functions and defined additional functions (based on clinical research regulations) that are needed for clinical research. The resulting profile has been balloted and approved as an HL7 Normative Standard (May 2008, Jan 2009) and is being submitted to ANSI (American National Standards Institute) as well as being considered as part of a certification by CCHIT (US Commission for Certification of Healthcare Information Technology). The profile has also been represented in format for submission to EuroRec for inclusion in their EHR repository (March 2009) and has been presented to CEN (EU Standards Commission). In addition to the profile, the group has recently released a white paper detailing what investigator sites should consider in using their EHR systems to supply source for clinical trials. The core group consists of very active participants from the pharmaceutical industry, EHR vendors and clinical research technology vendors and FDA, and participate in discussions with European regulatory organizations as well as European EHR certification authority EuroRec. For more information or to review deliverables from this project team, please see our project website, www.ehrcr.org, or contact any of the co-charis: Linda King (king_linda_s@lilly.com), Catherine Celingant (catherine.celingant@mpi.com), Suzanne Bishop (suzannekbishop@gmail.com), Richard Perkins (richard.perkins@con7.com). This project has a detailed project plan and is actively seeking external funding to continue as it is a long-term project. Current "Gold Level" funding partners are Eli Lilly and Company, Procter and Gamble, Pfizer, PhRMA and GSK.
Investigator Site EDC Survey -- The eClinical Forum did a comprehensive survey of investigator site's usage of EDC systems in 2001 (summary results are available for download on this website). Since then there has been much discussion of producing comparison results. A new online survey, based on the original 2001 survey, will be released in June 2009 with a target goal of 500 investigator responses. Results will be summarized and presented at industry conferences and via our website in 2010. A link to this survey will be available via this website homepage as soon as it is released.
SAE / AE Best Practices – As an outgrowth of a very popular Birds-of-a-Feather teleconference on the topic of SAE and AE best eclinical practices, this team was formed to continue and summarize the discussions. Workshop sessions were held at both the US and EU 2008 meetings. The team has combined the experience of all our members into a presentation on the various methods of collecting SAEs in an eCRF. This presentation will be taken externally to appropriate industry meetings in 2009. Their aim is to have a de facto best practice standard, plus some suggested steps towards achieving this. The presentation is available on the Members section of this website.
ePRO Handbook – This team is comprised of eCF members from the US and EU with the goal to develop a handbook to help organizations get started with ePRO. Sections of the handbook were worked on during workshops at several eClinical Forum meetings. The handbook has been released for eClinical Forum member-use only. It is in the process of being transferred into a "Wiki"-style document, such that industry-collaboration can be ongoing. It is anticipated to be released in the Wiki-style in 3Q 2009 on the new eClinical Forum website.
Data Management Metrics Definitions -- A subgroup was formed in 2008 to review definitions of metrics in an effort to encourage industry standards in this area. The group has been given the opportunity to collaborate with the Metrics Champion effort and will continue working with MC in 2009.
Bi-Monthly Teleconference Discussions on Current Topics -- Started in November, 2006, Bi-monthly teleconference discussion sessions (called "Birds of a Feather Sessions") are based on member-submitted discussion topics that focus on issues of current work situations. All members are welcome to submit topics for discussion (submit to suzannekbishop@gmail.com or richard.perkins@con7.com), to facilitate discussions and/or to attend any teleconference meeting. These Discussion Sessions / Webinars are free to all members, and member companies can have any number of participants.
Discussion Board on the Members Area of our website -- members can ask specific questions and get feedback from other members. Note: we have experienced a breach in security in this portion of our website and have closed down the Discussion Board. We are currently in the process of creating a new website with updated and more secure software and the new website will again feature a Members-Only Discussion Board. The new website is targetted for release 4Q 2009.
Future EHR/eSource Paper – This activity is completed and the resulting paper can be downloaded from the Knowledge Section of our website. Although the paper is now 2 years old, it is still a very relevant discussion on the potential use of EHR systems for gathering information for regulated clinical research. Anyone new to this discussion will find this paper to be extremely helpful in getting jump-started on this topic. The team was comprised of members from the eClinical Forum and PhRMA EDC Task Force. They met weekly for a year to discuss the scenario of using electronic medical records as source for clinical research. In Sept 2006, they released the discussion paper titled "The Future of EHR as eSource for Clinical Research". Articles based on this paper were published in Bio-IT World (January 2007) and Pharmaceutical Executive (Dec 2006). Team members presented the paper at several US and European industry meetings in spring and fall 2006. Presentation was also made to EuroRec and HL-7 Technical Committee. An outgrowth of this effort is the EHR Profile for Clinical Research (see above).