Electronic Health Records (eHRs)

The HPRA supports the move towards electronic health records (eHR) but recognises there is a need to facilitate their regulatory compliance with the current legislation (European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004 - S.I No. 190/2004, as amended). It is essential that there is a clear understanding of what the source data are for a trial, as a lack of control over the documentation could result in an inability to reconstruct the trial and the trial data being considered unreliable. eHRs that are used for clinical trials must provide evidence of a robust GCP compliant records management systems.

It should not be assumed that a provider of a clinical eHR system will have an understanding of GCP, and therefore investigators should supply the eHR system providers with appropriate user requirements to ensure GCP compliance.  It is strongly advised that institutions obtain input from experienced clinical trial practitioners (such as principal investigators, research nurses, data coordinators) on clinical trial source data requirements prior to the introduction of eHR. When establishing an eHR system the following should be considered

For the eHR system:

  • Maintenance of data integrity via ongoing data review, change control processes and clear audit trails;
  • Audit trails for information added to the eHR. Any new information added to the subjects’ medical notes (whether paper or electronic) should show when the entry was made and by whom, so that the documentation provides a full audit trail of events (any amendments/ deletions etc.);
  • The investigator should still be able to demonstrate their medical oversight of the trial when eHR systems are used. For example where all entries into the medical records are made by a research nurse it can be difficult to reconstruct the investigator’s input. A process should be incorporated into the system to enable investigators to verify the information recorded in the same way a paper record would have been signed and dated. The same principles should be applied to the review of other supporting documentation such as electronic laboratory results, imaging, pharmacy records etc. by the investigator;
  • Where edit functions are in place for images that form part of the health records e.g. to remove subject identifiers and insert subject numbers prior to the image being transferred to the sponsor, QC processes should be implemented to ensure the correct re-labelling of these images (and retention of the original);
  • Access to the system should be available for inspectors and sponsor representatives (e.g. monitors and auditors), which is limited to trial subjects only. This will enable source data verification of clinical trial subjects whilst protecting the confidentiality of non-trial patients. This should include access to audit trails;
  • System to flag clinical trial subjects and search for trial records within the eHR;
  • Appropriate archiving to ensure long term reliability, retrieval and reproducibility of electronic data (and metadata), in line with regulatory storage timelines (note this will be 25 years as standard under the new Clinical Trials Regulation 536/2014);
  • Written procedures in place to cover all of the above processes. These procedures could also be used to assure external sponsors that compliant eHR systems have been implemented;

The above specifications are in addition to the standard requirements for computer systems used in clinical trials, including:

  • physical security;
  • restricted access;
  • record of roles and access rights;
  • data protection;
  • back-up of systems;

    This guidance document should be considered along with the institution’s requirements for standard health care records and other applicable regulations and guidance (such as data protection legislation).
    Reference is also made to:

    • EMA GCP Inspectors Working Group Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (EMA/INS/GCP/454280/2010, dated 09 June 2010). Available at:

    http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_
    procedural_guideline/2010/08/WC500095754.pdf
    .