Privacy Notice Suspected Unexpected Serious Adverse Reaction Report (SUSAR) for Investigator Led Trials
In accordance with the requirements of SI 190/2004 (as amended) and the applicable EU legislation, the obligation for reporting of suspected unexpected serious adverse reactions (SUSARs) is met through the submission of relevant reports to EudraVigilance. In certain circumstances, in the context of investigator led clinical trials, when HPRA assistance with submission to EudraVigilance is needed, the HPRA receives reports of such SUSARs from relevant academic sponsors of clinical trials for human medicine.
The HPRA transmits SUSARs occurring in the clinical trials outlined above (excluding personal identifiers and contact details) to 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.
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 is provided, it is not anticipated that this information, alone or in combination with other information available to the HPRA, will identify any individual.
The HPRA does collect personal data of the sponsor submitting a SUSAR. This information comprises contact details of the sponsor and is collected to facilitate communication and follow up with the sponsor in relation to a particular report.
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
The HPRA is a data controller in respect of the sponsor personal data collected when a SUSAR is submitted. The personal data is retained indefinitely.
What are your rights under data protection law?
The right exists to request a copy of personal data held by the HPRA and to have any inaccuracies in such data corrected or deleted. Further details on data protection can be found here.
Further information
Further information on the EudraVigilance database and the EMA are available here: EMA & EudraVigilance
To make a request regarding your personal data under the GDPR, 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) 6764971
Fax:+353 (1) 6767836
Email: dataprotectionofficer@hpra.ie
Please ensure that you describe the records you seek in the greatest detail possible to enable us to identify the relevant records. The HPRA must confirm within one month if data is held and if so, the description of the data and the purposes for which they are kept. The Irish supervisory authority for data protection is the Data Protection Commission. They may be contacted here. Details of your entitlement to complain to the Data Protection Commissioner will be included in the decision letter or email.