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Routine workflow in a reference clinical research center in face of COVID-19.
Adriana Serdotte Freitas Cardoso1, Stella Marys Rigatti Silva1, Eneida Rejane Rabelo-Silva2,3
1Hospital de Clínicas de Porto Alegre (HCPA), Centro de Pesquisa Clínica. Porto Alegre, Rio Grande do Sul, Brasil.
Revista Gaucha De Enfermagem
|September 29, 2021
Summary
This study developed validated care workflows for clinical trial participants during the COVID-19 pandemic. These flowcharts ensure continuity and safety in research protocols, offering guidance for other institutions.
Area of Science:
- Clinical Research
- Public Health
- Pandemic Preparedness
Background:
- The COVID-19 pandemic presented significant challenges to clinical research operations.
- Maintaining participant care and research continuity required adaptive strategies.
Purpose of the Study:
- To develop and validate content for care workflows for clinical trial participants during the COVID-19 pandemic.
- To ensure the safety and continuity of clinical research protocols amidst public health crises.
Main Methods:
- A development study utilizing expert consensus was conducted from March to July 2020 in southern Brazil.
- Flowcharts were created based on literature review and validated by specialists for comprehensiveness, clarity, and pertinence.
- A 100% agreement index was achieved for all items in the developed instruments.
Main Results:
- Two validated care flowcharts were developed: 'Flow diagram to conduct protocols with research participant' and 'Flow diagram in protocols with research participant with suspected or confirmed COVID-19 infection'.
- These flowcharts outline essential activities to maintain the continuity of care for research participants.
Conclusions:
- Routine workflows are crucial for promoting the continuity and safety of clinical research protocols.
- The developed flowcharts can serve as a guide for institutions with similar research profiles facing pandemic-related challenges.
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