Accurate capture and reporting of adverse events (AEs) in clinical trials is critical to understand the potential harms to individuals receiving prospective therapies. A series of collaborative discussions with consumers, interdisciplinary clinical trialists and case study analysis, identified that clinical trials investigating non-pharmacological interventions rarely incorporate systematic capture of AEs and often report no harms. This has the potential for under-reporting, which could impact the safety of such therapies when implemented in clinical practice. Current AE-reporting frameworks (e.g., International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Guideline for Good Clinical Practice and the National Cancer Institute’s Common Terminology Criteria for Adverse Events), were developed to capture and report AEs that occur in pharmacological trials. Adaptation of pharmacological AE-reporting frameworks imparts a risk of excluding AEs unique to non-pharmacological interventions that have not yet been defined. For example, capturing a participants’ feeling of failure associated with an inability to complete a mindfulness-based intervention. Furthermore, there can be study setting-dependant AE-reporting disparities in non-pharmacological trials, with a risk of AEs not being captured when conducted in a community setting compared to a hospital clinic, due to rigid reporting frameworks and inadequate participant self-reporting. In addition, clinical trials focus primarily on the participant receiving the intervention, with current AE-reporting frameworks failing to recognise potential harms to participants’ families, carers, clinical and research staff. For example, the risk of harm to research nurses from participants presenting with unpredictable behaviour. This initiative aims to: (i) increase awareness for the potential under-reporting of AEs, particularly in non-pharmacological trials; and (ii) explore appropriate AE-reporting frameworks to aid the systematic capture and reporting of AEs experienced by all individuals, either directly or indirectly, participating in clinical trials. Addressing this gap will enable a comprehensive and accurate understanding of the potential harms of all types of prospective therapies.