The governing body of a health service, local health district or local health network may include a Chief Executive Officer (CEO, also called Chief Executive, Executive Director, General Manager).
The CEO role (or equivalent) is required to support a culture within their organisation of responsible clinical trial practice and ensure their staff are aware of their responsibilities. The position is responsible for ensuring all clinical trials undertaken within their organisation comply with the requirements of national and local legislation and ensures appropriate research governance, personnel, systems and structures are in place.
The CEO (or equivalent) is also responsible for:
- Ensuring effective communication across the organisation with key individuals responsible for clinical trials
- Monitoring clinical trials conducted within the health service organisation for compliance with policies and procedures
- Delegating a person responsible for Site-Specific Assessment (SSA) and site authorisation and, an escalation process for disputed local site authorisation of clinical trials if required
- Allocating sufficient resources for effective and efficient processing of ethical and scientific review by the Human Research Ethics Committee (HREC) and, SSA and site authorisation
- Establishing systems for the management of complaints about clinical trials, including clinical trial research misconduct and fraud
- Allocating resources for education and training of HREC members and site-specific assessment personnel
- Providing access to ongoing training and education that promotes and supports responsible clinical trial conduct for all members of clinical trial teams, researchers and those in other relevant roles such as staff in supporting departments
- Ensuring supervisors of clinical trial research trainees have the appropriate skills, qualifications and resources
- Providing access to facilities for the safe and secure storage and management of clinical trial data, records and primary materials and, where possible and appropriate, facilitate access for study personnel
- Ensuring mechanisms are in place to collect and report on operational metrics and other agreed measures of operational performance to the governing body as required
