The profile is the result of a collaboration between EuroRec and the eClinical Forum (eCF) which brought together global stakeholders from healthcare, pharmaceuticals, biotechnology, technology vendors and regulatory organisations.
According to Jos Devlies, Medical Director, EuroRec, “This is an important piece of work, offering clear guidance for the first time on the functions that a healthcare system needs if it is being used for clinical research".
With EHR systems becoming increasingly prevalent in European Healthcare establishments, the amount of data with potential use in clinical trials that is kept in an electronic format has increased. Unfortunately, the extent to which today’s EHR systems conform to the strict guidelines governing the use of electronic systems for clinical research is not known. Consequently, research sponsors are often reluctant to rely on the security of data held within healthcare systems and this uncertainty is contributing to the duplication of data entry to separate clinical trial systems and the ongoing maintenance of paper records. The eCF have addressed this by producing a set of user requirements that EHR systems should fulfill to enable the reuse of data for clinical research. This in turn has been the basis for the definition of the new EuroRec profile.
The new EuroRec profile is designed to establish a baseline standard for the functional and operational requirements for EHR systems to be compliant with clinical trial requirements. Having this standard available will help EHR system developers know what to provide and healthcare system implementers understand what to look for. Clinical trial sponsors and certification bodies will have an important basis for evaluating EHR systems as source data repositories for clinical trials.
Details of the profile, including information designed to support use, are accessible from the EuroRec website (see below).
It is also worth noting that this work has had a global scope. A sister profile, also developed by the eCF project team, has been endorsed by Health Level Seven® (HL7®), a healthcare standards organisation, which has also recently been approved as the healthcare industry's first ANSI (American National Standards Institute) standard. As both the EuroRec and HL7 profiles draw upon the same standard requirements for clinical trials, conforming to one will mean, in principle conformance to both.
Medicine is being transformed by the introduction of EHRs. The growth of EHRs brings with it important opportunities to improve the way data for clinical trials is handled. Healthcare, patients, industry and regulators would benefit enormously from an environment for the re-use of EHR data that could avoid today’s duplication of tasks and generation of paper. Such an environment would undoubtedly introduce requirements for new functionality in both healthcare and clinical trial systems and EuroRec will be monitoring these changing needs and introducing them into future versions of the EuroRec Profiles for Clinical Trials.
The eClinical Forum is also a not-for-profit professional association, with members from pharmaceutical companies, service providers, technology vendor and academia. Its mission is to support the pharmaceutical industry in shaping the future of the electronic clinical research environment. Visit http://www.eclinicalforum.org or the project website at http://www.ehrcr.org/
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