Ensaios clínicos patrocinados com uso de medicamentos: atos normativos e processos

Abstract

The development profile of clinical trials sponsored with medicine in the area of health and management, along with the normative acts in force, to define and organize the processes involved in these projects, has been a challenge for public institutions and for the whole chain involved. In this sense, this work aims to elaborate the processes involved in the development of clinical trials sponsored with medication, according to the legislation in force in public institutions. The work was divided in 3 steps: bibliometric analysis, documentary matrix and architecture and process mapping. It systematically raised 2,927 scientific articles, of which 5 eligible articles were related to the work theme. Subsequently, by means of a survey and matrix of the normative acts in force of the regulatory organs that involve the clinical trials, a table of norms was established to base the processes. The process architecture was built based on the table of normative acts and through them the process maps were created according to the current norms. The results obtained evidenced that the current publications do not contemplate all the processes of the object of study what characterizes this research as innovative; the process architecture becomes a material for consultation and identification of failures/excesses for all public institutions that conduct clinical trials sponsored with medication; in addition to the entire chain involved in the process, clearly and cleanly generating process maps that assist the services in directing their minimum activities, in line with current regulations.