CTN risks can be categorised into organisational, CTN, study, site and operational-level risks. These risks may vary according to site experience and location. Clinical trial risks can also be categorised into system and trial-level risks.
CTNs need to manage risks in compliance with statutory, regulatory, ethical, organisational and governance requirements and the establishment of a robust risk management process is vital.
ACTA Risk Management: Guidance for CTNs
This document is intended to assist Clinical Trial Networks (CTNs) in establishing risk management guidelines and policies.PDF