A central data monitoring fact sheet offers harmonised guidance
With the introduction of risk-based monitoring, strict on-site monitoring in clinical research projects is no longer reasonable or mandatory. This trend away from on-site monitoring has resulted in the implementation of alternative monitoring methods, and new approaches such as centralised monitoring processes may complement conventional monitoring. Central data monitoring (CDM) plays an important role here: it is not only a highly valuable (particularly in large multicentre trials) and often essential addition to on-site monitoring but may also help to reduce the number of (cost-intensive) on-site monitoring visits. For high-quality study data, a deliberate combination of conventional monitoring and CDM is required.
To date, especially in the academic setting of investigator-initiated trials, many stakeholders have not yet included CDM in their monitoring strategy. Because awareness of CDM is not yet widespread, it is not yet clear how CDM may contribute to data quality and study oversight. In addition, terminology in guidance documents is inconsistent and the application of CDM is not clearly described in guidance documents.
To address this lack of harmonised guidance, the Monitoring Platform prepared a fact sheet examining and describing CDM in detail. This fact sheet aims to not only support the members of the SCTO’s CTU Network but also reach the entire Swiss research community.
Because the fact sheet is freely accessible to third parties outside the SCTO, it is important to follow the general instructions on the fact sheet’s cover page.