Privacy Notice for Suspected Unexpected Serious Adverse Reaction Report (SUSAR) for Investigator Led Trials
The HPRA receives SUSARs (suspected unexpected serious adverse reactions) occurring in clinical trials from the EudraVigilance Database. This database is owned and administered by the European Medicines Agency (EMA), which is an agency of the European Union and is also subject to the laws of the European Union. Personal identifiers and contact details are not included in these reports.
In certain circumstances, the HPRA may also receive reports from relevant academic sponsors of clinical trials for human medicines. The HPRA may assist with submission of these reports to EudraVigilance.
What information do we process?
It is not expected that any personal data of clinical trial participants will be provided to the HPRA. While information such as the sex, age and an identifier number are provided, it is not anticipated that this information, alone or in combination with other information available to the HPRA, will identify any individual.
Contact details of the sponsor who submits the SUSAR are collected to allow the HPRA to follow up with the sponsor in relation to a report where required.
Legal basis for processing
The legal basis for processing personal data in incident reports is Article 6(1)(c) of the General Data Protection Regulation (GDPR), which states: Processing is necessary for compliance with a legal obligation to which the controller is subject.
Transmission of relevant SUSARs under the Clinical Trials Directive is required under SI 190/2004 (as amended) and associated EU legislation.
Transmission of relevant SUSARs under the Clinical Trials Regulation is required under SI 99/2022 (as amended) and associated EU legislation.
How is your information processed and shared?
The HPRA are a joint controller with the EMA for reports submitted to EudraVigilance. The joint controller arrangement in place can be viewed on the EMA website. Further information on the EudraVigilance database and the EMA are available on the EMA’s website.
The HPRA uses third party service providers and suppliers (also known as data processors) to carry out both our regulatory functions and other related matters. These third parties process personal data on behalf of the HPRA and appropriate arrangements are in place with them to protect personal data.
The personal data collected in relation to serious adverse event clinical trial investigators is not transmitted to third countries by the HPRA.
The personal data is retained permanently.
The HPRA fully respects your right to privacy and treats all personal information with the appropriate standards of security and confidentiality, strictly in accordance with data protection legislation.
What are your rights under data protection law?
Data protection law provides you with the following rights regarding the processing of your personal data:
- The right to request access to your data
- The right to request your data be rectified or erased if it is inaccurate
- The right to request processing of your data be restricted
- The right to lodge a complaint to the Data Protection Commission
How to contact us
For more information or to make a request regarding your personal data under data protection law, please submit your request in writing or via email:
Data Protection Officer
Health Products Regulatory Authority
Kevin O'Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2
Tel: +353 (1) 676 4971
Fax: +353 (1) 676 7836
Email: dataprotectionofficer@hpra.ie
Please provide sufficient information in your request to enable us to deal with your query.
Further information regarding data protection at the HPRA can be found in our main privacy notice.