ECRIN_Risk-Based Monitoring Toolbox

The risk‑based monitoring toolbox is an online resource developed by the European Clinical Research Infrastructure Network (ECRIN) to support proportionate monitoring strategies in multinational clinical trials. It provides structured information on tools used for risk assessment, monitoring and overall study conduct, together with details of the institutions using them, links for further information and user feedback. The toolbox was launched at the end of 2015 after a systematic review of published and grey literature (2006–2015) and a survey of clinical trial units and academic sponsors in the ECRIN network that identified existing risk‑adapted monitoring tools, risk evaluation methods and monitoring strategies. Monitoring is presented in a broad sense, covering onsite and central activities across trial design, conduct and analysis, and reflecting the regulatory move towards risk‑based oversight. Each entry describes the tool’s scope, format and purpose, and provides contact details for the originating team or a bibliographic reference so users can obtain and implement the tool. 

• Defines monitoring as the oversight of trial conduct to ensure adherence to the protocol, Standard Operating Procedures, Good Clinical Practice and regulatory requirements, with protection of participants and verifiable data as core aims.
• Emphasises an expanded view of monitoring that includes onsite and central activities, and strategies spanning design, execution and analysis phases.
• Frames risk‑based monitoring as the new regulatory paradigm, highlighting that there is no longer a “one‑fits‑all” model and that approaches must be adapted to local and trial‑specific context.
• Presents a curated toolbox of risk‑based monitoring and risk‑assessment tools (standard documents, checklists, procedures, software, devices, etc.), excluding commercial information‑technology and data‑management products.
• For each tool, provides a structured description of scope, format and purpose, plus contact details for the developing team or bibliographic references, allowing users to explore and implement tools directly with the originating group.