Guidelines for organization, operation and evaluation of clinical trials pharmacies in Brazil: a scope review

Abstract

The development of new drugs depends on several scientific steps, which culminate in clinical trials. The clinical trials pharmacy (CTP) is the place for receiving, preparing, storing and dis-pensing the investigational product or study drug. Therefore, it must have infrastructure and proce-dures that guarantee participant safety and quality of research data. This study aimed to systema-tize guidelines for CTP in Brazil. We conducted a scope review and organized the results using the Ishikawa Method (6Ms). In total, 51 publications were selected for each “M”, 39 laws, regulations or guidelines and 12 scientific articles: 25 publications for pharmaceutical services (pharmacy pro-cedures to ensure participant safety from investi-gational product ordering to final disposition), 14 for Quality Indicators, 12 for Human Resources, 11 for Infrastructure, 11 for Material Resources and 5 for Investigational Product. Our results syn-thesize information for the organization, operation and evaluation of CTP in Brazil, emphasizes the inclusion of the pharmacist within the clinical trials context, and contributes to preparation for monitoring, auditing, and inspections conducted by regulatory agencies.