The MHRA has issued guidance on managing access to electronic personal health data processed during clinical trials.
Clinical trials sponsors, via clinical research associates (CRAs) or monitors, verify and oversee the data collected and analysed during clinical trials (Source Data Verification). They review medical records to ensure this matches the data collected by the sponsor. The guidance addresses the challenges posed to patient confidentiality by electronic health records (EHRs) during this review process. The guidance is useful for sponsors, contract research organisations and investigator sites when complying with processing obligations.
1. Restricting access to patient data is key
The new guidance highlights the importance of using EHR systems that have the capacity to restrict research monitor access to relevant information about patients in the trial. Where an EHR system is being used in a clinical trial which does not have capacity to restrict access, organisations will have to update this in the next system update. The guidance also sets out mitigating steps that can be used in the interim before the system update, including the use of appropriate confidentiality clauses in the employment contracts of CRAs and monitors.
2. The problem with printing hard copies of EHRs
During inspections, the MHRA has seen some sites printing out EHRs in hard copy for monitors to review. This is problematic as it has the potential to comprise the confidentiality of healthcare data. This practice also risks providing CRAs and monitors with out-of-date or inadequate information.
3. EHR system design
EHR system design should ensure research monitor access is limited to only the records of clinical trial participants and that this access is auditable.