ABSTRACT
With the revision of the Good Clinical Practice (GCP) in 1997, the Clinical Trial Center was established at Saga University Hospital in 1999, where clinical research coordinators (CRC) of nurses and pharmacists have been carrying out support for clinical trials since June 2000. At present, two pharmacists, two nurses, and three clerical work assistants support the execution of clinical trials; however, in recent years the number of clinical trial commissions has been gradually decreasing. On this occasion, in order to carry out even higher quality and smoother clinical trials, we conducted a questionnaire targeting the sponsors of clinical trials (head monitors) to evaluate this hospital's system for the execution of clinical trials from the sponsor's standpoint. Moreover, for the purpose of comparison with the systems of other institutions, the same questionnaire was conducted on two other hospitals-the University of Occupational and Environmental Health, Japan and the Social Insurance Shimonoseki Kousei Hospital. The problems of the clinical trial execution in our team turned out lack of knowledge concerning GCP and our complex system from the result of the questionnaire.
Subject(s)
Clinical Trials as Topic , Hospitals , Humans , Japan , Nurses , Pharmacists , Surveys and QuestionnairesABSTRACT
Os frutos de umbu (Spondias tuberosa Arr. Cam.) maduros são altamente perecíveis, e o aproveitamento deles no estádio de maturação verde, sob a forma de doce é uma interessante alternativa econômica, para o semi-árido nordestino. A conservação da cor, durante o armazenamento, constitui um fator de qualidade dos mais importantes para o consumo, e o presente trabalho objetivou avaliar sua alteração em função de diferentes formulações, embalagens (polipropileno e celofane) e temperaturas (33 e 43°C), por 90 dias de armazenamento. A adição de pectina e/ou xarope de glicose não alterou a luminosidade (L*), mas diminuiu os valores de a* ( intensidade do vermelho ) e b*. ( intensidade do amarelo). Verificou-se diminuição dos valores de L* a* e b*, notadamente para os doces armazenados à temperatura de 43°C e para a formulação sem adição de pectina. A embalagem não exerceu efeito significativo sobre L*( luminosidade), mas afetou a* e b* aos 90 dias de estocagem, em ambas as temperaturas. Os resultados globais indicaram o uso de pectina e xarope de glicose, embalagens de polipropileno e estocagem à temperaturas mais baixas como sendo as condições mais adequadas para preservação da cor.
Ripe umbu (Spondias tuberosa Arr. Cam.) is highly perishable, thus using unripe umbu to make marmalade is an interesting economic alternative for the semi arid northeastern region in Brazil. Color conservation during storage is one of the major quality factors for consumption. This work aimed to evaluate color alteration in function of different formulations, packagings (polypropylene and cellophane) and temperatures (33 and 43°C) over 90 storage days. Pectin and/or glucose syrup adittion did not alter luminosity (L*), but decreased a* (red intensity) and b*(yellow intensity) values. L* (luminosity), a* ( red intensity) and b* (yellow intensity) values were found to decrease, especially for marmalade stored at 43°C and formulation without pectin addition. The package did not influenced the L* (luminosity), but at 90 days of storage, this factor influenced the values of a* and b* parameters em both temperatures. The overall results indicated the use pectin-and glucose syrup-added formulation , packaging in polypropylene pots and storage at lower temperatures as being the most adequate conditions for color preservation.