HRB NCTO WORKING GROUPS

HRB NCTO WORKING GROUPS

HRB NCTO delivers a considerable amount of its activities via working groups made up of appropriately skilled and knowledgeable representatives from its network. Working Groups are in place to deliver on Work Plans across areas such as quality, study feasibility, study start-up, clinical trial contracts and budgets, patient and public involvement and pharmacovigilance. Ultimately the aim of the working groups is the delivery of streamlined transparent processes for clinical research across the institutions.

For more information on any of the working groups below contact info@ncto.ie

HRB NCTO delivers a considerable amount of its activities via working groups made up of appropriately skilled and knowledgeable representatives from its network. Working Groups are in place to deliver on Work Plans across areas such as quality, study feasibility, study start-up, clinical trial contracts and budgets, patient and public involvement and pharmacovigilance. Ultimately the aim of the working groups is the delivery of streamlined transparent processes for clinical research across the institutions.

HRB NCTO Quality Working Group (QWG)

The QWG consists of the Quality and Regulatory Affairs Managers across the centres and chaired by the HRB NCTO QRAM to work on numerous quality elements for the delivery of clinical trials in Ireland. The mission of the QWG is to facilitate cooperation and sharing within the HRB NCTO partnerships with respect to quality, compliance and training matters, such that harmonisation is promoted, duplication is avoided and available resource is maximised. The group developed a Mutual Recognition Policy for the conduct of Clinical Research within the centres and are implementing a peer review programme.

For more information contact ruben.keane@ucc.ie

STUDY Feasibility and Start-up Working Group (SFSWG)

Consisting of the site Study Feasibility and Start-up facilitators at each of the centres and co-chaired by Dr Fionnuala Keane, Director of Operations, RCSI Clinical Research Centre and Michèle Cunnane HRB NCTO Trial Platform Lead (TPL). The mission of the SFSWG is to facilitate cooperation and sharing within the HRB NCTO partnerships with respect to efficient delivery of investigator and site selection and study start-up and first patient first visit timelines.

Budget Working Group (BWG)

The HRB NCTO Budget Working Group consists of personnel working in each centre responsible for budgeting and costing of clinical trials. This group is co-chaired by Dr Aideen Doherty, Programme Manager, Clinical Research Facility, University of Galway and Michèle Cunnane HRB NCTO Trial Platform Lead (TPL). The mission of the group is to streamline and standardise the protocol review and budget development process nationally.

Pharmacovigilance Working Group (PWG)

The NCTO PvWG consists of Pharmacovigilance representatives from each of the HRB-Clinical Research Facilities/Centres. It is co-chaired by Prof. Pat Murray Clinical Director, UCD Clinical Research Centre and Dr. Ruben E. Keane, NCTO QRM. NCTO PvWG aims to share best practice and experience, avoid duplication and maximise resources in this highly specialised area of Clinical Research. We discuss issues of common interest, the level of Pv Activity across the region, how to implement Pharmacovigilance under new legislation (Clinical Trials Regulation, Medical Device Regulation etc). The group produces an annual report (for HRB) on the level of Pv Activity across the HRB-CRF/Cs.

MedTech Working Group (MTWG)

The Medtech Working Group is co-chaired by Prof Martina Hennessy Director, Clinical Research Facility, St James Hospital and Olive O’Driscoll Clinical Industry Liaison Officer, NCTO. Members include representatives from the Clinical Trial Facilities/Centres, Enterprise Ireland, and Irish Medtech Association, IBEC. The group puts strategies and supports in place to help medtech manufacturers to navigate the Irish clinical investigation ecosystem and support companies to conduct high quality clinical investigations in Ireland.

Quality Working Group (QWG)

The QWG consists of the Quality and Regulatory Affairs Managers (QRAMs) across the HRB Clinical Research Facilities/Centres. It is co-chaired by Prof. Paul Burke Director, Clinical Research Support Unit, Limerick and the HRB NCTO QRAM, Dr. Ruben Keane. The mission of the QWG is to facilitate co-operation and sharing within the HRB NCTO CRF/C network with respect to quality, compliance and training, to promote harmonisation, avoid duplication of effort and maximise available resources. We share knowledge and best practice and discuss issues of common interest at our quarterly meetings.