Purpose This work explores the potential benefits of aligning the strategic planning process with a BPM program in a clinical research center (CRC). The purpose of this paper is to define a process for executing strategic planning oriented towards the promotion of a BPM program. Design/methodology/approach The method applied is action research. This allowed the solution of a practical problem and at the same time the proposition of a new approach to promote BPM in alignment with strategy, which was synthesized in the model presented. Findings The analysis and structuring of the strategic planning process, with the assessment of the as-is situation, were adequate as a preparation step for the first cycle of a BPM program in the CRC. Based on lessons learned along the research project, a model was proposed for the strategic planning process oriented towards promoting BPM. Research limitations/implications The model was conceived from a single application at a CRC, through a cycle of action research. This is one of the limitations of this work. The model was not yet sufficiently tested in other contexts. This represents opportunities for future research. Practical implications The evaluation step in the action research cycle revealed that the organization in focus was satisfied with the results. New management practices in the organizations in focus were implemented as a result of this work. Originality/value Process improvement initiatives are a novelty in the CRC context, and this work may serve as a reference for CRC managers seeking to improve overall performance. The proposed model in this work indicates that a BPM program should start with strategic planning. An initial assessment of the as-is situation of the organization in focus was performed based on the analysis of the undesirable effects in the organization’s management practices, using a technique of the Theory of Constraints. The use of this technique facilitated the identification of solutions to the root causes identified in the assessment. The level of the assessment was deeper in comparison to results obtained with traditional tools used in strategic planning processes. The assessment supports the definition of actions oriented to solving the majority of the management dysfunctions of the organization in focus.
Modelo do estudo: Estudo transversal nos 32 centros participantes da Rede Nacional de Pesquisa Clínica (RNPC). Objetivos: Desenvolver e validar um questionário eletrônico capaz de medir o desempenho dos centros participantes da RNPC em uma auditoria de qualidade baseada nas Boas Práticas Clínicas (BPC). Avaliar a correlação do instrumento com o guia de inspeção em BPC disposto na Instrução Normativa nº 4, de 11/05/09 da ANVISA (IN4/ANVISA) e verificar, por meio do questionário desenvolvido, o desempenho dos centros participantes da RNPC, em relação ao atendimento a requisitos de um sistema de gestão da qualidade (SGQ). Métodos: Foi aplicado um questionário eletrônico, legitimado por uma validação de conteúdo. As questões foram agrupadas em três domínios, infraestrutura, estrutura organizacional e processos. Os dados foram pontuados de acordo com o cumprimento (1) ou não cumprimento (0) em BPC. As questões do questionário foram arbitrariamente correlacionadas aos itens da IN4, atribuído (0) ponto às questões conformes e (1) para não conforme. O índice de cumprimento para atendimento aos itens críticos e maiores (ICCM) foi calculado para cada domínio usando a equação ICCM = 1 * (Escore IN4) + valor total escore para dado domínio. As comparações foram feitas por teste de Kruskal-Wallis e teste de Spermann, considerando P valor < 0,05. Resultados: O instrumento representa aproximadamente 40% dos itens do roteiro de inspeção da IN4/ANVISA. A pontuação obtida com o questionário correlaciona-se significativamente ao escore correspondente à IN4/ANVISA (r=0,95, 0,89 a 0,98, IC95%, P<0.0001). A mediana do ICCM foi menor que 75% em todos os domínios estudados. Conclusões: O instrumento desenvolvido para medir o desempenho em BPC apresenta alta correlação com a IN4/ANVISA e poderia ser utilizado para auditoria interna de qualidade. A classificação para itens críticos e maiores definidas pela IN4/ANVISA mostrou-se muito restritiva e necessita ser adequada a realidade dos centros de pesquisa nacionais.
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