HSE Cyber Security Incident and Clinical Trials

v 1.0, dated 25 June 2021

The HPRA acknowledges the impact of the HSE cyber security incident from 14 May 2021 on the health system and the potential impact this may have on clinical trials and subjects.

The full impact on clinical trials conducted in Ireland is yet to be determined, however, the HPRA continue to liaise with the Department of Health and the HSE regarding the outcomes of the incident.

In the interim, the below general guidance is intended to provide clarity on the conduct and management of clinical trials at this time. Pragmatic solutions may be required to manage the challenges of conducting research, and in ensuring the rights, safety and wellbeing of subjects. It is important to consider the potential impact on the clinical trial and subjects and to implement suitable alternative measures where necessary.

  • It is noted that access to EDC/eCRF systems may have been disrupted due to the incident. It should be considered how activities typically conducted via electronic data capture (EDC)/electronic case report form (eCRF) systems may be facilitated, including patient registrations and SAE reporting. It is also noted that delays in the entry of data in EDC/eCRF systems may have arisen, and these should be entered at the next reasonable opportunity.

  • Where study visits and clinical trial procedures are impacted, flexibilities outlined in the HPRA and joint European Commission/EMA/HMA guidance for the conduct of clinical trials during the COVID-19 pandemic may be beneficial. Guidance may be accessed in the links below.

  • For trials using electronic health records (EHRs), sites should consider the suitability of continuing to use these, and may consider switching to paper records in the interim, until it is considered safe to return to the use of EHRs.

  • The impact on the provision of Investigational Medicinal Product (IMP) to subjects should be considered, for example if study visits are postponed/cancelled, which result in difficulties in subjects receiving IMP. Reference is made to flexibilities outlined in section A.5 of the HPRA Guidance on the Management of Clinical Trials during COVID-19.

  • An increase in protocol deviations may arise during this time. It is important that such deviations are clearly documented (ref: ICH GCP E6 4.5.3). A proportionate approach will be taken by the HPRA when such deviations are reviewed during inspections, in particular where the best interest of the subject is maintained, and the subject is not put at undue risk. This does not allow for the use of prospective “protocol waivers”.

The HPRA is committed to providing all necessary support during this time and will provide further guidance as required.


HPRA COVID-19 and Clinical Trials 

HSE Daily Update

Joint European Commission/EMA/HMA Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic

State Indemnity Guidance