HRB CRCI Quality Working Group Establishment

HRB CRCI Quality Working Group Establishment.

The HRB CRCI Quality Working Group (QWG) established a terms of reference for it’s operation on 3 March 2016. The group consists of quality and training representatives from each of the partner CRF/Cs and is chaired by the HRB CRCI Quality and Regulatory Affairs Manager, Ms. Sinead Curran. 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 objectives of the QWG are, as follows:

  • Promote harmonisation through sharing of information, including but not limited to systems, procedures, processes, experiences;
  • Agree minimum standards for quality systems, thereby laying the foundation for mutual recognition amongst partners;
  • Support the provision of training in clinical research by the partners, including standardisation of the approach taken;
  • Provide considered opinion on the approach to implementation of legislation/standards relating to clinical research;
  • Workshare on horizon scanning activities, ensuring changing legislation and guidance is identified and formulating advice and guidance, as appropriate;
  • Implement a system for risk based auditing to support mutual recognition of partner quality management systems;
  • Provide a forum for continued development of QRAMs/Quality representatives.
  • To ensure effective collaboration with interested stakeholders, on relevant issues, as necessary.

The group will meet quarterly to discuss matters in line with it’s mission and objectives and as outlined in an annual work plan.

Nominations from interested academic or hospital institutions, for a representative with responsibility in the area of quality, compliance and/or training related to clinical research, to join the group will be opened after June 2016.

HRB CRCI wishes the QWG every success in it’s endeavours.