Banca de DEFESA: ROBERTO EIDER LIRA NETO

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : ROBERTO EIDER LIRA NETO
DATE: 06/09/2024
TIME: 14:00
LOCAL: Remoto
TITLE:

Health Accreditation: Systematic Review for the Evaluation of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation in Clinical Research Centers

KEY WORDS:

Accreditation. Research Center. Clinical Research. AAHRPP.

PAGES: 88
BIG AREA: Engenharias
AREA: Engenharia de Produção
SUMMARY:

Clinical Research is defined as any scientific investigation conducted on humans, involving experiments of high methodological rigor, aimed at discovering new treatments for diseases and assessing the safety and efficacy of new drugs. This provides answers to various questions related to therapeutic practices and the quality of healthcare services. Patient Safety is becoming an increasingly discussed topic in light of the new services offered by healthcare. ANVISA established in RDC No. 36 of 2013 the requirement for the creation of Patient Safety Units in healthcare services and the reporting of Adverse Events (AE) associated with patient care. In Clinical Research Centers, it is necessary that all clinical study protocols are conducted with the highest quality required by pharmaceutical companies and regulatory agencies, ensuring adherence to the protocols with guaranteed quality, reporting any AEs or errors in the study protocol processes, and continuously developing a culture of improvement. The methodology of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) proposes a quality certification in Patient Safety in Clinical Research through quality procedures and policies. The main objective of the research is to analyze bibliographic studies in scientific databases directly related to institutions conducting clinical research, using AAHRPP methodology as a quality criterion for safety protocols. This study aims to bring the AAHRPP methodology to Brazilian Research Centers so they can use it as a basis for creating or monitoring their processes, making them capable of receiving proposals for globally relevant clinical studies. In doing so, it will bring science and new therapeutic technologies closer to the population, demonstrating how well-conducted clinical trials directly impact health promotion.

COMMITTEE MEMBERS:
Presidente - 1229030 - HELIO ROBERTO HEKIS
Interna - 1777131 - MARIANA RODRIGUES DE ALMEIDA
Externa à Instituição - IVANETE SCHNEIDER HAHN