As part of an initiative to have quicker and more efficient research governance authorization, Australia’s National Health and Medical Research Council (NHMRC) has developed the Good Practice Process for Site Assessment and Authorization Phases of Clinical Trial Research Governance.
The Good Practice Process was developed and finalized following extensive stakeholder consultation by the NHMRC’s Research Governance Working Group. This group has broad representation from clinical trials sites, clinical trial sponsors and state/territory health departments.
The Good Practice Process aims to streamline the site assessment and site authorization of clinical trials by:
Outlining a set of principles and critical success factors for site assessment and site authorization;
Detailing a set of planning and preparation activities that can made a site more responsive to commencing clinical trials; and
Proposing a streamlined workflow for site assessment and authorization.
NHMRC is piloting the Good Practice Process in 16 clinical trial sites across seven states and territories.
Once details on the effectiveness of the Good Practice Process have been collected, and any modifications made, it is expected that the Good Practice Process will be implemented at all clinical trials sites to facilitate a standardized approach to clinical trials research governance.
