Table 1

Risk factors to consider when justifying centralised data monitoring and on-site monitoring using a risk-based approach to monitoring clinical trials. Source: Food and Drug Administration (see related web links for further detail)

FactorRationale for justification
Complexity of study designMore intensive monitoring may be required for studies with adaptive designs, complex dose titrations or multiple device placements.
Types of endpointsSubjective endpoints may require more on-site visits to ensure consistency. Objective endpoints (eg, death, lab values) may be more suitable for centralised data monitoring.
Clinical complexity of populationSeriously ill or vulnerable populations may require more on-site monitoring to ensure appropriate protection.
GeographyStandards of medical practice may vary between regions. Sites with less established CT infrastructure may require more frequent on-site monitoring.
Experience of PI and sponsorIncreased monitoring may be required on principal investigators or sponsors who lack significant CT experience or have previously failed regulatory audits.
Electronic data captureCentralised data monitoring can capture real-time quality metrics, such as missing data, data errors or protocol violations to identify high-risk sites for on-site monitoring.
Safety of interventionTapered approach may be required with increased monitoring early on until preliminary safety data has been reviewed.
Quantity of dataCentralised data monitoring may be more useful for large trials with multiple sites and long duration.
  • CT, clinical trial; PI, principal investigator.