Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combination products are required to provide oversight, including ensuring proper monitoring of the investigation.
Such oversight helps to ensure adequate protection of the rights, safety, and welfare of participants in the clinical investigation and the integrity of the data submitted to FDA.
Therefore, sponsors should implement a system to manage, throughout all stages of the clinical investigation, both risks to participants (e.g., a safety problem) and to dataintegrity (e.g., incomplete and/or inaccurate data).
This guidance provides information on risk-based approaches to monitoring the conduct of clinicalinvestigations of humandrug and biologicalproducts, medicaldevices, and combinationproducts.
Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned.
This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.
This guidance expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) (the 2013 RBM guidance) by providing additional information to facilitate sponsors’ implementation of risk-based monitoring.