Implementing the ICF with a risk-based approach with the CRDe

Introduction: With the development of new technologies, the development of clinical trials (CTs) and electronic Data Collection Forms (DCRFs) has evolved. The traditional monitoring activity (MT) where 100% of the data was checked, has shifted to risk-based monitoring (RBM) and in particular, to comprehensive central monitoring (ICM). Aim: To implement ICM with the CRDe for a risk-based approach. Materials and Methods: Critical variables to be monitored in a clinical trial were selected. Key Risk Indicators (KRIs) were developed based on recommendations made by the regulatory agency. An MBR plan was developed. ICM was conducted at two points in time to measure the KRIs. Traditional monitoring was compared with comprehensive central monitoring for ICRs and to assess the transport, diet and accommodation costs generated by the monitoring activity. Results: 25 critical variables were chosen to be monitored in the selected clinical study, as recommended in the literature. With ICM, missing data were reduced by 83.03%, incorrect data by 97.36% and inconsistent data by 63.54%.