MHRA – The impact of EHR on UK Clinical Trials

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.

If you would like to attend this teleconference please contact ellie.huckle@techuk.org 

  • Ellie Huckle

    Ellie Huckle

    Programme Manager | Central Government
    T 020 7331 2015

Share this

FROM SOCIAL MEDIA

For #WorldEnvironmentDay see how @tiktok_uk are supporting their climate champions who are sharing Eco Tips https://t.co/TZalCemgtB
On Monday we're holding a webinar on mandatory human rights due diligence - a massive issue that will see tech firm… https://t.co/lMuidodUVq
It's your last chance to vote in the biennial techUK Cyber Management Committee Elections. Voting closes at 5pm on… https://t.co/RBly4wAsQk
How are ecologists using sounds to protect biodiversity? @PurdueAg from @HPE explains #WorldEnvironmentDayhttps://t.co/VziysyqkXe
Next @SopraSteria_uk outlines what emerging best practice looks like on environment, climate #WorldEnvironmentDayhttps://t.co/Eva9Qr7TuK
Today, the COP26 Champions launch their Race to Zero campaign. @gmunozabogabir and @martineaus explain why you shou… https://t.co/lvGLZ5Z886
Scott Butler from @RecycleElectrics outlines a new campaign to get the UK recycling electricals & why brands have a… https://t.co/R9qd4rGAqO
Guest blog: Justin Day, CEO at @cloudgatewayltd looks at how we should prepare for a post-Covid future as part of o… https://t.co/7Kp9p06tzF
Next a guest blog from @gabrielle_giner outlining a new series of initiatives, to help @BTGroup meet its net zero g… https://t.co/xcWwgijFzv
How is digital being used for nature & climate. And what challenges remain. @SanneBaker blogs from @techUKhttps://t.co/YsgEpYnjxW
Become a Member
×

Become a techUK Member

By becoming a techUK member we will help you grow through:

Click here to learn more...