Access to EHR Guidance
The Research Governance team have been in discussion with the MHRA regarding their recent changes to guidance concerning direct access for Sponsor representatives to Electronic Health Records (EHRs), guidance found here. The term EHRs refers to any electronic systems used to capture patient records. The Trust operates a hybrid system of both electronic (i.e. Laboratory Information Systems (LIMs), and primarily paper health records.
Sponsor representatives are not able to have direct access to the Trust systems at present since read only retractions to specific trial participants is not possible. In line with the MHRA’s advice we have notified the Trusts IM&T department of the access requirements for consideration at the next update to the system(s). However, the MHRA do recognise that many of these systems are not developed in house and that research is generally not considered high priority by the developers of the system but every effort will be made to address this wherever possible. It is likely over time that EHRs will integrate inputs from the various separate systems so access should become easier.
In the interim guided access will be supported. Certified copies will continue to be produced but acknowledge these are likely to be less suitable as they lack the supporting audit trails and require retention to support what the monitor reviewed.