Mapeamento e qualificação dos processos na fase pré-estudo de pesquisas clínicas de iniciativa do patrocinador em um hospital universitário
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Data
2025-05-21
Autores
Silva, Vanezia Gonçalves da
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Universidade Federal do Espírito Santo
Resumo
Introduction: Federal university hospitals are characterized by the complexity of their organizational structure, which encompasses multiple interdependent processes focused on care, teaching, and research. In the context of clinical research, this complexity is accentuated due to the multiplicity of responsibilities and stakeholders, institutional interfaces, and operational flows involved in conducting studies. When such processes are not properly defined and articulated, they can lead to rework, inefficiency, and compromise scientific and administrative results. Objective: To analyse the institutional processes that comprise the pre-study phase of sponsor initiated clinical research at a university hospital. Method: This is an action research study based on the need for collective knowledge construction. Professionals from different areas who worked on clinical research protocols at the university hospital participated in the study. The theoretical framework was supported by a scoping review on clinical research management, which guided the development of process mappings and a guidance manual for the pre-study activities. The development and validation of these products took place through six seminars, recorded in audio and video, transcribed, and submitted to Bardin’s categorial and lexical analysis using IRaMuTeQ software to identify challenges in conducting research. Results: The technical products – process mapping and manual – represent practical contributions, as they offer a structured basis for organization, clarity of responsibilities, optimization of flows, and ethical and legal compliance. Academic productions such as the scope review and articles, one focused on analyzing the process mapping development and the other on lexical analysis exploring the challenges, can inspire other institutions that encounter similar difficulties in structuring and managing clinical research in public university environments.
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Mapeamento de processos , Pesquisa clínica de iniciativa do patrocinador , Hospitais universitários