Routine workflow in a reference clinical research center in face of COVID-19

Abstract

ABSTRACT Objective To develop and validate the content of workflows for trial participants care in a clinical research center during the Covid-19 pandemic. Method development study by consensus of experts carried out from March to July 2020 in southern Brazil. The flowcharts were developed following literature and validated by specialists considering comprehensiveness, clarity and pertinence, obtaining a 100% agreement index on each item of the developed instruments. The study was approved by the Ethics Committee of the institution. Results two flowcharts of care were elaborated and validated: “Flow diagram to conduct protocols with research participant " and "Flow diagram in protocols with research participant with suspected or confirmed COVID-19 infection"; which describes activities to ensure continuity of care. Final considerations a routine workflow can promote the continuity and safety of clinical research protocols. It is expected that the adopted flowcharts in this study can guide other institutions with a similar research profile.