In:
Ciência & Saúde Coletiva, FapUNIFESP (SciELO), Vol. 27, No. 8 ( 2022-08), p. 3103-3116
Abstract:
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 dispensing the investigational product or study drug. Therefore, it must have infrastructure and procedures that guarantee participant safety and quality of research data. This study aimed to systematize 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 procedures to ensure participant safety from investigational 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 synthesize 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.
Type of Medium:
Online Resource
ISSN:
1678-4561
,
1413-8123
Uniform Title:
Guidelines for organization, operation and evaluation of clinical trials pharmacies in Brazil: a scope review
DOI:
10.1590/1413-81232022278.04052022
Language:
Portuguese
,
English
Publisher:
FapUNIFESP (SciELO)
Publication Date:
2022
detail.hit.zdb_id:
2078799-6
SSG:
7,36
Permalink