Whether basic or complex, small or substantial, a planned and precise outline of clinical trial organisation measures must underpin trial conduct and associated approaches to management. The development of these organisational requisites include consideration of site structure, essential stakeholders such as internal and external committees and delineation of individual roles and responsibilities of key study personnel. One of the most important factors for consideration during pre-study planning, for not only study sponsors but sites and CRO’s regarding the development of trial organisation is establishing a framework for trial governance.
Governance, in the clinical research context refers to the,”…processes used by institutions to ensure that they are accountable for the research conducted under their auspices” (www.australianclinicaltrials.gov.au). To address a number of essential requirements for the conduct of clinical trials research including protection of human participant’s, fulfilment of basic quality management principles and ensuring ethical, law-abiding provision of service, trials must be conducted according to established ethical principles, guidelines for responsible research conduct, relevant legislation and regulations and institutional policy.
Governance for sites specifically is also about educating, credentialing, professional protection of site personnel and managing institutional risk. Research governance encompasses many human research-specific considerations but also illustrates good business practices for site managers, supports trial quality and promotes awareness of the requirements for progressive stages of trial conduct. These include, amongst other conditions that may be specific to particular sites or institutions:
- Ethical approval (HREC, IRB)
- Site and institutional policies and procedures for ethical, responsible research conduct and managing research misconduct
- Compliance with legislation, regulations, guidelines and codes of practice
- Legal considerations, including contracts, and indemnity/insurance frameworks
- Financial management, risk management and site-specific assessment
- Management of stakeholder communications
- Distinct reporting requirements
(National Health and Medical Research Council, 2014)