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 (EHR/CR) Profile team is working towards producing a set of functions and criteria in order for EHR systems to be qualified for use as a source of data for clinical research. The EHR/CR Profile team 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). The project team is now exploring how this standard profile could be used as a reference standard for clinical research certifications of EHR systems in both the US and EU. It will be submitted in EU-appropriate form to EuroRec in 3Q 2008. 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. The group was coordinated by the eClinical Forum and PhRMA EDC/eSource Taskforce. For more information, please see our project website, www.ehrcr.org, or contact any of the co-charis: Linda King (king_linda_s@lilly.com), Suzanne Bishop (suzannekbishop@comcast.net), 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, and PhRMA.
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 Spring 2008 meetings. The team is currently combining the experience of all our members into a presentation on the various methods of collecting SAEs in an eCRF. This presentation will be previewed at the Autumn 2008 eClinical Forum meetings and will then be taken externally to appropriate industry meetings. Their aim is to have a de facto best practice standard, plus some suggested steps to start people off on the way to that.
EMR Survey – This team of members from both US and EU have developed a survey for completion by healthcare organizations (survey has been closed (Sept '07) with nearly 100 responses). A team has begun working on summarizing the data for publication. At this point in time, results are for eCF members only
The survey had the following goals:
ePRO Handbook – This team is comprised of eCF members from the US and EU 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 anticipated that it may be released for wider use towards the mid to end of 2008.
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, 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.
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 1.5 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. On September 14, 2006, they released a 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).