Monitoring
The purpose of monitoring is to ensure that the rights and well-being of study participants are protected, data is accurate, complete, and verifiable, and that the conduct of the study complies with the protocol/amendment(s), ICH/GCP and applicable regulatory requirements. A risk based monitoring strategy will be conducted. HOVON decides on the risk of the study, and determines the required frequency and timing of monitoring visits as specified in the Monitoring Plan. Monitoring will be performed by HOVON monitors or monitors assigned by the study group / CRO.
For sites in the Netherlands, the HOVON monitors will also evaluate the echelon level and can assist you in raising the organization of HOVON trials at your site to a higher Echelon level (see echelon classification).
Monitoring visits
The monitor will contact you in time to make an appointment for a monitoring visit, indicating which documents he or she wishes to examine during the visit. We would ask the site Principal Investigator to be available for a discussion of the findings and the study status. During the monitoring visit the following tasks will be performed:
· Review of Informed consent documents and process
· Review of protocol compliance and Source Document Verification of a selection of items and patients as defined in the monitoring plan
· Review of safety reporting
· Review of essential documents in the Investigator Site File
· For Dutch sites: evaluation of the echelon classification
· Analysis of the Drug Accountability process (if applicable)
· Discussion of the findings with the pharmacist/pharmacy assistant (if applicable)
· Discussion of the findings with the Site Principal Investigator, Trial Coordinator and Local Data Manager.
The monitor will report the findings to the site Principal Investigator and local study team through a Follow Up Letter.
Contact
If there are uncertainties about the monitoring or monitor visits, you can contact HOVON on the central number +31(0)10 704 1560 and request to speak to a HOVON monitor.