Data managers and clinical research coordinators: a tool to collect the hourly activity

Background and Aims: the main purpose of this paper is analyzing the hourly activities performed by Data Managers (DMs) and Clinical Research Coordinators (CRCs) in a Clinical Trial Center (CTC) of an Italian Public Hospital in order to define and monitor the relevant job descriptions of these professionals Materials and Methods: the CTC of the Research and Innovation Departments (DAIRI) has created a tool to collect the hourly activity of DMs and CRCs. In the period between January 1 and December 31, 2022; the activities were collected and grouped in 24 macro areas. Results: the main activities conducted by staff are found in the macro areas "Study Management" (15.78%); "Briefing/Planning" (12.86%) and “Data Management/Data Entry” (12.42%). A difference was found between the activities carried out by CRCs and those conducted by DMs. Conclusions: the results of this monitoring, compared with data obtained at the national level, confirm the heterogeneity of the tasks performed by these professional figures. These differences increasingly underscore the need to obtain recognition of the figure by the National Health System (NHS) with the definition of a precise “job description”.