Banca de QUALIFICAÇÃO: ROBERTO EIDER LIRA NETO

Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.
STUDENT : ROBERTO EIDER LIRA NETO
DATE: 10/04/2024
TIME: 10:00
LOCAL: https://meet.google.com/uof-hxrr-oks
TITLE:

IMPACT OF ACCREDITATION ON THE QUALITY AND EFFICIENCY OF CLINICAL RESEARCH AND PATIENT SAFETY: THE USE OF THE AAHRPP METHODOLOGY

KEY WORDS:

Accreditation. Research Center. Clinical Research. AAHRPP.

PAGES: 55
BIG AREA: Engenharias
AREA: Engenharia de Produção
SUMMARY:

Clinical Research is defined as any scientific investigation conducted in humans, through experiments of high methodological rigor, in order to discover new treatments for diseases and to verify the safety and efficacy of new drugs. Thus, answers to various questions regarding therapeutic approaches and the quality of health care are obtained. Patient Safety is becoming an increasingly debated topic in light of the new services offered by health care. Anvisa established in RDC No. 36 of 2013 the obligation to create Patient Safety Centers in health services and to report Adverse Events (AEs) associated with patient care. In Clinical Research Centers, it is necessary that all clinical study protocols occur with maximum quality demanded by pharmaceutical companies and regulatory agencies, being complied with guaranteed quality, reporting when there are AEs or errors in study protocol processes, always developing a culture of continuous improvement. The methodology of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) through quality procedures and policies proposes a quality certification when it comes to Patient Safety in Clinical Research. The main objective of the research is the observation and analysis of institutions that conduct clinical research using the methodology of AAHRPP as the basis for protocol implementation and efficiency of their studies. Thus, bringing knowledge of the internationally recognized method to Brazilian Research Centers where they can use it as a basis for the creation or monitoring of their processes, making them able to receive proposals for clinically relevant studies. Thus, making science and its new therapeutic technologies closer to the population, attesting to how well-conducted clinical trials directly affect health promotion.

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