HRB CRCI Quality Working Group (QWG)

 

Since 2015, the HRB CRCI QWG have been collaborating to address regulatory and quality challenges, to share quality best practice and to deliver the HRB CRCI mutual recognition scheme.

Background

The HRB CRCI Quality Working Group (QWG) was established in 2015, and consists of quality, regulatory and training representatives from each of the partner CRF/Cs. One of the key deliverables of HRB CRCI was to form the HRB CRCI Quality Working Group and to deliver the Mutual Recognition Scheme of the Clinical Research Facilities/Centres Quality Systems.

Mission

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 harmonization is promoted, duplication is avoided, and available resource is maximized.

Objectives

The key objectives of the HRB CRCI QWG include:

  • Implementation of the Mutual Recognition Scheme of the CRF/Cs Quality Systems
  • Horizon Scanning Programme to monitor changes to regulations/legislation
  • Sharing of Quality Best Practice amongst the group
  • Third party stakeholder consultation with key stakeholders such as the HPRA, DOH and HSE
  • Training; identify and address common training needs

Working Group Structure & Membership

The group is coordinated by the chairperson which is the HRB CRCI Quality and Regulatory Affairs Manager (QRAM) and the group meet once per quarter. The group agree an annual work plan which is approved by the HRB CRCI Senior Management Team.

The QWG is comprised of core and non-core members. The core members are representatives from organisations from the HRB CRCI network. Non-core members are representatives from organisations outside of the HRB CRCI membership.

How to get involved

To express interest in joining the group please contact the QWG Chairperson, the HRB CRCI QRAM Fiona Cregg.