The purpose of the monitoring activity is to ensure that the rights and welfare of the subjects are protected, and that the clinical trial (ClinO) or clinical trial with medical device (ClinO-MD) data entered into the database is accurate, complete and verifiable from the source documents.
It also oversees the conduct of a clinical trial or a clinical trial with a medical device and ensures that it is conducted, recorded and reported in accordance with the study protocol, applicable quality documents, Good Clinical Practice (GCP) (ICH E6 GCP 5.18) and applicable regulations.
The platform can assess the risk of your clinical trial (ClinO & ClinO-MD) and develop the monitoring plan for your study. In addition, it can carry out the monitoring activity, according to ICH GCP E6(R2). The monitor will perform this activity according to a pre-established monitoring plan adapted to the risk of the clinical trial and according to IUFRS Standard Operating Procedures. He or she will verify that the clinical trial is conducted and that data are generated, documented and reported in accordance with the protocol, GCP and applicable regulatory requirements. In practice, an initiation visit, intermediate visits and a closing visit will be organised on site by the monitor in accordance with the monitoring plan.
