HRB CRCI Quality Working Group – update December 2016

The HRB CRCI Quality Working Group (QWG) has been in existence for one year. The group consists of quality, regulatory and training representatives from each of the partner CRF/Cs. 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.

The QWG meets quarterly and has accomplished many of its initial objectives in this relatively short time period.

Main achievements/ outputs to date:

  • Harmonised Good Clinical Practice training across the CRF/Cs. All GCP courses run at the CRF/Cs meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
  • Developing and sharing training materials for new courses/ presentations including :Introduction to Clinical Research, ICH-GCP Revision 2 update, Medical Device Investigations for Study personnel, Forthcoming EU CT regulation 536/2014.
  • Drafted a guidance document on Sponsor responsibilities (Currently in Draft 2.0)
  • Introduced a Mutual Recognition Scheme for Quality Management Systems of CRF/Cs. Step 1 and Step 2 complete, Step 3 in progre
    • Step 1: Agreeing minimum expectations and related guidance, for Quality Management Systems (Completed September 2016).
    • Step 2: Drawing up a self-assessment questionnaire (Completed September 2016).
    • Step 3: Completing self-assessment questionnaire (gap analysis) and estimating time need to meet the minimum expectations (Due Jan 2017)
    • Step 4: Carrying out audits across the CRF/Cs to ensure each QMS meets the required standard. Planned to take place from May 2017.
  • Members of the QWG have carried out work on behalf of ECRIN on updating the CAMPUS database.
  • A member of the QWG delivered a talk on the implications of the EU regulation 536/2014 (on behalf of QWG) at UK CRF Network conference in July 2016
  • Horizon scanning to ensuring changing legislation and guidance is identified and communicated to CRF/Cs and study personnel as appropriate.
  • QWG sent comments on ICH-GCP revision 2 during consultation phase.
  • Sharing best practice and new ideas to enhance Quality and Regulatory activities across CRF/Cs.