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.

The user-friendly Monitoring Visit Report and Monitoring Plan templates were developed by the SCTO’s Monitoring Platform to harmonise the documentation of monitoring visits and monitoring plans. This is particularly helpful for multicentre studies. However, the templates are useful not only for multicentre studies within the SCTO’s CTU Network but for all sites doing clinical research.

Because these templates are freely accessible to third parties outside the SCTO, it is important to follow the general instructions on the templates’ cover pages.

Our Monitoring Platform represents a pool of experienced monitors joining forces to develop practical monitoring solutions for clinical studies. We’re pleased to announce a trio of resources to help you manage your study monitoring, first released together in June 2019. Use them to find the best monitoring strategy for your study, based on predefined considerations.

Here you can download and explore:

• our revised Guidelines for Risk-Based Monitoring, published as Appendix 3 of the Guidelines for Good Operational Practice (GGOP), Version 2.0 
• our new Risk-Based Monitoring (RBM) Score Calculator, provided as an interactive Excel spreadsheet, and
• its comprehensive User Instructions

To obtain competent answers to general monitoring questions or to offer feedback on these resources, contact us at monitoring@scto.notexisting@nodomain.comch.

For any trial to reach its conclusion, monitors are crucial. Whereas auditing serves a quality assurance (QA) function, monitoring provides quality control (QC), through which study conduct is checked, step by step. Simply put, monitors aim to detect issues and rectify them, preventing existing errors from recurring and new ones from developing. Before, during, and after the trial, monitors assess whether what is planned, described, and approved is realised as intended.

Every trial must be conducted, recorded, and reported correctly, meaning that it should adhere to protocol, Standard Operating Procedures, Good Clinical Practice, and the relevant regulatory requirements – all of these being aspects of QC. Monitoring was developed internationally as a profession to render trials more cost effective, of higher quality, and ultimately to help them reach conclusive results. Monitors are effectively guardians of both processes and people. They oversee that trial data is accurate, complete, and verifiable, while checking that the rights of participants are protected. When both processes and people are protected in this way, more trials can run to completion.

Would you like to know how the experts in the Monitoring Platform are channelling their efforts? For more information, consult the fact sheet below.