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. The HRB NCTO Working Groups are as follows:

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

HRB NCTO Feasibility and Study Start-up Working Group (SFSWG)

Consisting of the HRB NCTO Feasibility and Study Start-up facilitators at each of the centres and chaired by the HRB NCTO CTLM. 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.

For more information contact: mcunnane@ucc.ie

 

HRB NCTO 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. The mission of the group is to streamline and standardise the protocol review and budget development process nationally.

For more information contact: mcunnane@ucc.ie

HRB NCTO Pharmacovigilance Working Group (PWG)

The PWG consists of the staff involved in providing pharmacovigilance services across the centres and chaired by the HRB NCTO QRAM. The mission of the PWG is to facilitate cooperation and sharing within the HRB NCTO partnership with respect to pharmacovigilance.

For more information contact: ruben.keane@ucc.ie

HRB NCTO MedTech Working Group (MTWG)

The Medical Device Directives was replaced by the Medical Device Regulations in 2021.  These regulations impose stricter requirements of designers, developers and manufactures of medical devices.  A MedTech Working Group was setup in December 2019 to prepare for this transition. This Working Group will be reactivated in 2022.