The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator. Decisions made by this team (as specified in the EHRCR User Requirements Document, Release 1) were reviewed and commented on by an international group of key stakeholders. Their opinions have been taken into consideration while formulating this functional profile. More information on the workings of this project team can be found at www.ehrcr.org