Good clinical trial governance provides confidence to the community and everyone who works in a health service organisation conducting clinical trials or trial site that there are systems in place to support the efficient delivery of high-quality clinical trial services.
A well-governed healthcare organisation ensures managers and clinical trial site staff, patients, consumers, clinical trial sponsors and the health service organisation is accountable for their contribution to the delivery of clinical trial services.
The governing body is the board, or the individuals, with overall responsibility for the health service organisation or trial site. The governing body is also the approving authority.
The governing body endorses and monitors multidisciplinary teams of experienced professionals, all contributing to the conduct of clinical trials as the health service organisation.
This includes services and staff such as:
- Information technology (IT)
- Human resources
- Clinical and non-clinical teams
- Site-level trial investigators
- Trial managers
- Study coordinators
- Human Research Ethics Committee (HREC) office
- Governance office
- Site-specific assessment staff
Safety, risk and compliance
The governing body ensures clinical trial services, and all services, operate well and deliver high-quality clinical trials in a safe environment. It does this by establishing a strong safety and risk management culture through an effective clinical trials governance system. The role of the governing body is to ensure that the system operates effectively and efficiently, and there is an ongoing focus on quality improvement.
The governing body identifies and complies with laws, regulation, national and jurisdictional guidelines and policies relating to the conduct of clinical trials. The governing body also ensures there is appropriate designation of responsibility and accountability with clear lines of communication between all those involved in clinical trials.
The governing body implements quality systems and processes to ensure that staff work to appropriate guidelines and standards and that processes are in place for continuing professional development, including training in TGA: Guideline for Good Clinical Practice (GCP).
Proactive training for staff enables a clinical trials workforce that is competent and appropriately skilled.