The up-to-date and user-friendly Monitoring Plan Template can be used to set up a monitoring plan.
This template helps sponsors to create a monitoring plan according to the guidelines for Risk-Based Monitoring, including defining the extent and strategy of monitoring, visit scheduling, and monitoring activities as well as clarifying the monitor’s, sponsor’s, and investigator’s responsibilities. It is part of a series of monitoring templates that includes:
This template is suitable for any monitor and
sponsor engaged in clinical research in Switzerland and abroad. We particularly
recommend using this template within the SCTO’s CTU Network for
investigator-initiated, multicentre studies.
This template was developed by the SCTO’s Monitoring Platform and first published in June 2020 and last updated in February 2022 (V2.0).
The numerous monitoring responsibilities that exist can be found in ICH GCP and ISO 14155. Compliance with the protocol is important in order to ensure ethical conduct of clinical trials, scientific validity, and the accuracy and completeness of data produced during a clinical study. Monitoring helps to ensure this compliance. With this template, we aim to improve the quality and consistency of the monitoring of investigator-initiated, multicentre studies within the SCTO’s CTU Network.
This template is licensed under CC BY-NC 4.0. The content can be shared and adapted as long as you follow the license terms. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/.
Feel free to contact us with any questions or feedback related to this resource!