On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). To register attendance, click here, noting that attendance is restricted to those actually involved in development of these systems
The Medicines & Healthcare products Regulatory Agency (MHRA) and techUK would like to invite electronic health record suppliers to our digital discussion on the importance of these systems in ensuring the UK remains as a global leader in clinical trials. Having held an initial positive first steps telecon with some providers back on 3 September 2019, we committed to continuing this conversation in person to enable us all to talk in more detail about the requirements of electronic health records under the clinical trials legislation, and how we can best work together to meet those requirements within systems already implemented and in use, as well as those in development.
At the call on 3 September 2019 we discussed the fact that 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. We also discussed the statutory inspections conducted by the MHRA of clinical trials which also report considerable inspection findings with source data due to issues with electronic health records.
This face to face meeting is an opportunity to discuss these issues with the MHRA in much more detail, to understand the required functionality such as controlled and segregated access, audit trails recording entries, deletions and changes made to all data and where your systems are currently at in this process. 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 meeting is very much 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 both Pharma and non-commercial organisations continue to see the UK as an attractive location of excellence to conduct their clinical trials, while also ensuring the systems work efficiently for standard clinical practice.
Following the telecon on 3 September 2019 we circulated the below links to those that attended as background reading ahead of this face-face meeting, to ensure as developers you have some familiarity with these expectations before we meet again – this meeting is open to those that attended the call, but also very much an open invitation to other developers working on electronic health record systems that would like to be part of taking this forward and supporting the UK’s position in clinical research.
- MHRA GCP website, which includes links to UK legislation for clinical trials, as well as how they are regulated.
- MHRA Position Statement on Electronic Health Records
- Recent post on Electronic Health Record Issues.
- Trial Master File guidance document – while this is not directly relevant to Electronic Health Records many of the concepts apply so you may find it useful to read.
- Data integrity guidance document – this applies to all ‘XP’ areas regulated by the MHRA including GCP, and includes key concepts on what is expected to ensure the integrity of data (which includes source data i.e. that retained in the electronic health record systems).
To register your attendance, please click here.
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