HRB CRCI 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 CRCI Working Groups are as follows:
HRB CRCI Quality Working Group (QWG)
The QWG consists of the Quality and Regulatory Affairs Managers across the centres and chaired by the HRB CRCI 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 CRCI 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.
HRB CRCI Feasibility and Study Start-up Working Group (SFSWG)
Consisting of the HRB CRCI Feasibility and Study Start-up facilitators at each of the centres and chaired by the HRB CRCI CTLM. The mission of the SFSWG is to facilitate cooperation and sharing within the HRB CRCI partnerships with respect to efficient delivery of investigator and site selection and study start-up and first patient first visit timelines.
HRB CRCI Budget Working Group (BWG)
The HRB CRCI 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.
Clinical Research Patient and Public Involvement Working Group (CR-PPI-WG)
The Clinical Research Patient and Public Involvement Working Group (CR-PPI-WG) consisting of representatives from the Clinical Research Facilities/Centre’s, Clinical Trial Networks (CTN’s), PPI interested organisations, IPPOSI and HRB CRCI. The mission of the working group is to facilitate cooperation and sharing within the member organisations with respect to PPI knowledge, resources, training and innovation.
HRB CRCI Legal Working Group (LWG)
Health Research – Data Protection Network (HRDPN)
The Health Research Data Protection Network (HRDPN) is coordinated by HRB Clinical Research Coordination Ireland and consists of data protection officers and other legal representatives involved in data protection working in Irish universities, their associated teaching hospitals and other health research organisations and networks.
HRB CRCI Pharmacovigilance Working Group (PWG)
The PWG consists of the staff involved in providing pharmacovigilance services across the centres and chaired by the HRB CRCI QRAM. The mission of the PWG is to facilitate cooperation and sharing within the HRB CRCI partnership with respect to pharmacovigilance.
HRB CRCI MedTech Working Group (MTWG)
The medical device Directives will be replaced by the medical device Regulations from 2020 to 2024. These regulations impose stricter requirements of designers, developers and manufactures of medical devices. This group was set up in December 2019 to prepare for this transition regarding clinical data requirements.