Good Practice Processes for Site Governance and Authorisation of Clinical Trials

Good Practice Processes for Site Governance and Authorisation of Clinical Trials

The National Health and Medical Research Council (NHMRC), in response to a government initiative, was tasked with streamlining the conduct of clinical trials in Australia by shortening the time taken for the site governance and authorisation process at trial sites. The NHMRC had designed a ‘Good Practice Process for the Governance and Authorisation of Clinical Trials’ and wished to conduct a national consultation process with researchers, industry, governments, and public and private sector organisations to obtain stakeholder input on the proposed process including identifying any barriers to implementation.

HealthConsult was engaged to design and roll out the national consultation program. The work involved developing a consultation paper and using it as the basis of a wide-ranging series of interviews and focus groups held across the country. HealthConsult analysed the information received and prepared a report on the consultations that set out the main findings.

The work resulted in important refinements to the NHMRC’s ‘Good Practice Process for the Governance and Authorisation of Clinical Trials’, which has since been implemented in a number of hospitals hosting clinical trials.