Monitoring on the stage of clinical trial preparation
Procedures for deciding whether to conduct a clinical trial differ in various pharmaceutical companies and contract research organizations. The final decision depends on many factors and is accepted by the top management of the sponsor / CRO. However, before a final decision is taken, a certain number of formal procedures must occur. The clinical trial feasibility is included in these procedures, and a clinical study monitor may be involved in this process.
However, after deciding to locate a study in the appropriate country, a monitor more often is appointed, a final list of sites is formed, the number of patients that should be included in each of the sites is determined. Depending on the CRO procedures, the monitor may be involved in the process of preliminary selection of medical sites (site feasibility) for conducting a clinical trial. The first step is signing a confidential disclosure agreement (CDA), after which the monitor sends a synopsis and a questionnaire to the site, then receives the completed questionnaire and passes it to the project manager. Based on the results of the analysis of the collected information, a list of sites for conducting selection visits (Site Selection Visit) is formed. This visit can be conducted independently of previous work experience, to verify and discuss the requirements of a specific Protocol and to comply with the standard operating procedures (SOP) of the company. At this stage, the scientific biographies of the Principal Investigators (preferably co-investigators) are collected, the exact name and address of the site, its clinical bases, where the research is supposed to be carried out. Based on the results obtained during the visit, a final decision is made on the participation of the site in the project. Then a file is prepared with the materials of the study, which is sent to the official authorities for their examination and obtaining approval for the research.
The monitor, if properly qualified, can participate in the process of verifying the translations of Protocol, IB, ICF and other research documents, and is also involved in the preparation of the trial file (TMF) and the file of the research site (ISF). It is worth mentioning that he or she is also the main link between the sponsor and the investigator.
It’s easy to see that even before the start of the research, both the whole team and the monitors have a lot of work. X7 Research CRAs efficiently and unerringly manage all the procedures of the clinical part of the study at the stage of clinical trial preparation.