Risk management and classification 

Risk management is an essential part of the design and conduct of medical scientific research and is primarily the sponsor's responsibility. According to ICH GCP E6(R3) and the UMCNL Guideline on Quality Assurance of Research Involving Human Subjects, sponsors must apply a risk-proportionate approach to identify, evaluate, control and periodically review risks that may affect participant safety, rights and well-being, data quality, research conduct, or compliance with applicable regulations. 

Study specific risk management 

A study-specific risk assessment should therefore be performed as early as possible during study preparation, preferably while drafting the research protocol. Potential risks related to the study design, intervention, study population and trial conduct should be identified through assessing each risk by considering its potential impact, probability and detectability and evaluate the overall level of risk. Appropriate risk control and mitigation measures should be defined and implemented. 

The identified risks, their likelihood and potential impact as well as the proposed mitigation measures should be documented in the research protocol, for example in the Structured Risk Analysis section and will be evaluated by the review committee (MREC or CCMO). Furthermore the risk assessment classification is used during the local feasibility assessment and supports the sponsor in determining  risk.proportionate monitoring and appropriate quality assurance measures throughout the study (e.g. a Data Safety Monitoring Board (DSMB), Trial Steering Committee etc.).  

Risk management is an ongoing process. Risks and mitigation measures should be reviewed throughout the study and updated when new risks emerge or when substantial amendments are made. 

Risk Assessment and Classification Tool 

Amsterdam UMC developed a template for risk assessment and classification GCT T15 Risk Assessement and Classification Tool clinical research. A digital tool based on GCT T15 is currently being developed. Until this Amsterdam UMC tool becomes available, investigators should use the Swiss Clinical Trial Organisation (SCTO) Risk Based Monitoring Score Calculator, as this methodology closely aligns with the Amsterdam UMC GCT T15 framework. The outcome of the completed risk assessment must be included in the local feasibility process and used to support decisions on monitoring and other risk management activities. Guidance for completing the tool are available in GCT T15A and on the website of the Local Review Human Research office.