Management of a Brazilian site for clinical research in oncology: Quality of service

Brazil has participated in conducting an increasing number of clinical trials aimed at the development of new drugs and research products in oncology, supported by several national and international pharmaceutical industries. Managing and conducting clinical trials involve a high number of activities that must be rigorously observed and followed, particularly regarding the safety and protection of research subjects, good clinical practices mentioned in the Document of the Americas and the regulatory aspects in force. With the objective of informing health professionals working in the clinical research area and summarizing the managerial profile of a clinical studies center, this article presents the complexity of research in Brazil, its regulatory, ethical, and quality aspects in conducting studies with reliability in oncology through literature review and daily practice that is not always easily available to all interested parties.