The national unification body has submitted the project proposal to a preliminary public inquiry which intends to define the requirements for the professional figure who supervises the progress of a clinical study. There is time until July 21st to participate.
12 JULY – The Clinical Monitor is a professional who supervises the progress of a clinical study to ensure that this is carried out, recorded and reported in compliance with the protocol, the Standard Operating Procedures (Sop), the Good Clinical Practice (Gcp) and the provisions applicable regulations. It is a profession that is well present in our country but without an order or register, i.e. not regulated. The Italian national unification body (Uni), in order to introduce a regulatory instrument that defines the requirements of the profession, has launched a preliminary public inquiry on the subject.
Under the competence of the "Unregulated professional activities" technical commission, the future standard will define this professional figure in the various ways in which it operates (freelancer, employee), in compliance with the tasks defined by the Gcp.
The intention that drives the work of the commission "Unregulated professional activities" is to offer a certain reference and an adequate guarantee of quality to the market, increasing the professional recognition of individual professionals, as well as providing a useful tool to the legislator, in a perspective of complementarity between voluntary technical standardization and the mandatory sector.
Once the professional figure of the Clinical Monitor has been defined and qualified, in compliance with the European Qualifications Framework (Eqf), the whole category could derive an immediate advantage from it and the user could find in the competence and professionalism of this figure a point of sure and reliable reference.
Until 21 July, all interested parties can send their comments, possibly signaling their interest in participating in the standardization work. From the search form of the online database of the projects submitted to the preliminary investigation is Fr
