Outputs of the National Clinical Trials Oversight Group
- Foilsithe:
- An t-eolas is déanaí: 20 Samhain 2025
The National Clinical Trials Oversight Group (NCTOG) was established in July 2024 with the aim of generating recommendations to increase the number of clinical trials of investigational medicinal products in Ireland. This page contains links to the NCTOG’s outputs such as their recommendations and guidance documents.
Recommendations
Guidance
Data Protection Impact Assessment (DPIA) responsibilities during setup and conduct of a clinical trial
The following guidance was developed by the National Clinical Trials Oversight Group (NCTOG) to clarify organisations’ responsibilities around Data Protection Impact Assessments when setting up clinical trials.
The guidance has been developed through an iterative process as follows:
- Content was drafted based on Department of Health and NCTOG understanding of the regulatory environment, informed by consultations with public and private sector stakeholders and legal advisors, as well as the Data Protection Commission (DPC).
- Revision and updating following review by NCTOG and DPC.
- Final versions reviewed and approved by the DPC.
Scenario 1: Sponsor as Data Controller; Trial site as Data Processor
Scenario 2: Sponsor and Trial site as Joint Data Controllers
This guidance may be downloaded as a pdf document via the link below.
National Clinical Trials Oversight Group membership
|
Name |
Role and Organisation |
|
Prof. Donal Brennan (Chair) |
Professor of Gynaecological Oncology, University College Dublin (UCD). Gynaecological Oncologist, Mater Hospital. |
|
Prof. Alistair Nichol |
Chairperson, National Research Ethics Committee for Clinical Trials. Professor Of Critical Care Medicine, University College Dublin. Director, Irish Critical Care-Clinical Trials Network. Consultant Anaesthetist and Intensivist, St Vincent’s University Hospital. |
|
Dr Ana Terres |
Assistant National Director, Head of Research and Evidence, Health Service Executive (HSE). |
|
Dr Caitriona Walsh |
Board of Directors, Irish Pharmaceutical Healthcare Association, Managing Director Innovative Medicines and Country President, Novartis Ireland. |
|
Dr Cepta Duffy |
Manager, High Potential Start Ups - Industrial and Lifesciences Department, Enterprise Ireland |
|
Prof. Fidelma Dunne |
Professor in Medicine, University of Galway. Consultant Endocrinologist, Galway University Hospital. |
|
Dr Finnuala Lonsdale |
Director Human Product Authorisation and Registration, Health Products Regulatory Authority (HPRA). |
|
Ms Lucy Nugent |
CEO, Tallaght University Hospital (2019 - end 2024). CEO, Children's Health Ireland (commenced Jan 2025) |
|
Dr Mairéad O'Driscoll |
CEO, Health Research Board (HRB). |
|
Prof. Martina Hennessy |
Clinical Pharmacologist and Consultant Physician, St James’s Hospital. Director, Wellcome Health Research Board (HRB)-Clinical Research Facility, St James’s Hospital. Associate Professor in Medical Education, Trinity College Dublin (TCD). Deputy Chair, Health Research Board (HRB) Clinical Research Coordination Ireland (CRCI). |
|
Mr Muiris O'Connor |
Assistant Secretary General, Research and Development and Health Analytics, Department of Health. |
|
Prof. Paul McNally |
Associate Professor of Paediatrics, Royal College of Surgeons Ireland (RCSI). Director of Research and Innovation, Children’s Health Ireland (CHI) Crumlin. |
|
Prof. Peter Doran |
Director, University College Dublin (UCD) Clinical Research Centre. Professor of Clinical Trials, University College Dublin (UCD) School of Medicine. |
|
Dr Robert O'Connor |
Director, Health Research Board (HRB) National Clinical Trials Office. |
|
Ms Sabhbh O’Neill |
Head of Research, Tallaght University Hospital. |
|
Ms Rose Kidd |
President, Operations Delivery, ICON Plc. |
|
Prof. Seamus O'Reilly |
Consultant Medical Oncologist, Cork University Hospital Clinical Lead, Cancer Trials Ireland. |
|
Ms Simone Walsh |
Programme Manager, Irish Research Nurses and Midwives Network. Activation Manager, Royal College of Surgeons Ireland (RCSI) Clinical Research Centre. |
|
Ms Siobhán Gaynor |
Patient and Public Involvement representative. |
|
Ms Vicky McGrath |
CEO, Rare Diseases Ireland. |