Monitoring of studies is necessary to guarantee the quality of HOVON studies. HOVON decides on the risk of the study, and determines whether the HOVON monitor visits are sufficient or whether study-specific monitoring is required.
A SEV is a review of the overall quality whereby HOVON trials are carried out at a site. The monitors can also assist you in raising the organization of HOVON trials at your site to a higher Echelon level (see echelon classification).
The site Principal Investigator plays a central role in this review, because he or she bears final responsibility for conducting the trial at his or her department. During the SEV the monitor will conduct an interview with the site Principal Investigator on local agreements and working procedures in performing HOVON trials. In addition the results of the working procedures will be examined by checking a random sample of trial documents.
Depending on the number of trials currently undertaken in a site, the frequency of visitation will be determined. If you have up to eight HOVON protocols currently in your hospital, you can expect a visit from one of the monitors once a year. If you have more than eight HOVON protocols currently running at your site, your hospital will be visited twice a year.
Site Evaluation visits and study specific monitoring
The monitor will contact you in time to make an appointment for an SEV, indicating which documents he or she wishes to examine during the visit. We would ask the site Principal Investigator to hand over these documents and to be available for the interview and for the discussion of the findings from the random sample.
Prior to a SEV two trials will be selected randomly. These trials will be monitored during the SEV, whereby the following elements will be at issue:
- Interview with the site Principal Investigator of one of the trials
- Review of the Central Site File (if applicable)
- Review of the Investigator Trial Files of the selected trials
- Source Document Verification of two randomly selected, patients; of both trials one patient
- Interview with a pharmacist
- Analysis of the Drug Accountability process
- Discussion of the findings with the pharmacist
- Discussion of the findings with the Site Principal Investigator
The monitor will report the findings to the site Principal Investigator through a Follow Up Letter and Visit Report.
A number of HOVON trials require study specific monitoring. If study specific monitoring is necessary, the HOVON organization might delegate this kind of monitoring to a CRO.
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 for the responsible Global CPM if your question is trial related. If you have a general monitor question, you can request to speak to a HOVON monitor.