MED-NET office based staff and contracted freelance CRA perform all activities necessary for ongoing monitoring of the study. Company has developed internal SOP for study monitoring however the majority of the studies monitored by our company are international multicentre projects and for this reason sponsor’s SOPs are applicable. Thus we have implemented SOP tracking system in every project with the employee responsible for updating the information about the changes and modification in applicable SOP.
• Preparation of monitoring plan;
• Investigator’s teams training;
• ongoing personal, phone and mail contacts with investigators and sponsor;
• preparation of the materials and agenda for planned monitoring visits;
• performing onsite monitoring visit according to monitoring plan and applicable SOP;
• preparation of monitoring visit report;
• preparation of the periodic overall study reports for sponsor;
• study materials and study medication tracking;
• study documentation tracking;
• collecting the originals of the study documentation to be archived by sponsor;
• assistance in query generation and query resolution process;
• collection of clean CRF and original query forms from the centers;
• resolving the problems reported by investigator (ex. courier problems, communication issues, IVRS);
• performing the final study visit and closing the centre.