The Medicines & Healthcare products Regulatory Agency (MHRA) and techUK would like to invite electronic health record suppliers in both primary and secondary care, to our digital discussion on the importance of these systems in ensuring the UK remains as a global leader in clinical trials.
Global and national Pharma companies, Contract Research Organisations (CROs) and NHS Trusts themselves report issues to the MHRA on the compatibility of electronic health records with the requirements of clinical trials - to have clear contemporaneous and accurate source data that can be accessed and reconstructed. The MHRA conduct statutory inspections of clinical trials and also report considerable inspection findings with source data due to issues with electronic health records.
This telecon is an opportunity to speak with the MHRA at their request, to understand the required functionality such as controlled and segregated access, audit trails recording entries, deletions and changes made to all data. In some cases the MHRA has seen that the systems have the functionality already, but the end-users are not aware of or trained on exactly what the system is capable of. As the Regulator, the MHRA seeks to understand whether it is system changes or further education that may be necessary in order for electronic health records to meet the requirements of the clinical trials regulations, and this call is to seek your input to this as the leading developers in this area.
The aim of this discussion is for both the MHRA and system providers to understand what we can do to improve the current situation, and ensure that global Pharma continue to see the UK as an attractive location of excellence to conduct their clinical trials, while also ensuring the systems also work efficiently for standard clinical practice.