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.

To connect with experienced monitors or to offer feedback on these resources, contact us at monitoring@scto.notexisting@nodomain.comch.

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.