Electronic records certification body EuroRec has released a profile spelling out the key functionality required for an electronic health records (EHR) to be considered a reliable source of data within clinical trials.
EuroRec says the publication of the EHR profile will help promote the use of high quality electronic health records in Europe.
The new EHR profile intends to establish a common standard for the functional and operational requirement for EHR systems to be compliant with clinical trial requirements.
According to EuroRec, the extent to which EHR systems conform to strict guidelines surrounding the use of electronic systems for clinical research is currently unknown. As a result research sponsors can be unsure on the security of data held within healthcare systems and risk potential duplication of data entry in separate clinical trials.
The EuroRec institute and eClinical Forum compiled the profile after consulting global stakeholders from the healthcare pharmaceutical, biotechnology, technology vendor and regulatory industries.
The two organisations believe that the standard will ensure that EHR system developers know what to provide in order for data to be considered reliable and healthcare system implementers will know what to look for when searching for a reliable source.
Jos Devlies, medical director at EuroRec, said: “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.”
EuroRec says it will continue to monitor the changing needs for requirements for new functionality in both healthcare and clinical trial systems and introduce them into future versions of the EuroRec Profiles for Clinical Trials.
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