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Sample translations submitted: 1
Portuguese to English: Protocolo Final (Medicina)
Source text - Portuguese ÉTICA
Conselho Nacional de Ética (CNE) ou Conselho Institucional de Revisão (IRB)
Aprovação documentada dos Conselhos Nacionais de Ética (CNEs)/Conselhos Institucionais de Revisão (IRBs) serão obtidos para todos os centros/países participantes antes do início do estudo clínico, de acordo com ICH GPC, leis locais, regulamentos e organização. Quando necessário, uma aprovação de extensão, emenda ou renovação do CNE deve ser obtida e também encaminhada à (Nome da empresa). Os CNEs devem fornecer ao patrocinador uma lista dos membros do CNE, e uma declaração para confirmar que o CNE é organizado e opera de acordo com a GCP, leis aplicáveis e regulamentos.
Conduta Ética do Estudo Clínico
Os procedimentos estabelecidos neste protocolo de estudo clínico relativos a conduta, avaliação e documentação deste estudo clínico, são determinados para assegurar que o Patrocinador e Investigador Principal obedecem ao Manual de Boas Práticas Clínicas (GCP na versão atualizada). O estudo clínico será também executado de acordo com a(s) lei(s) local(is) aplicável(is) e regulamento(s). Isto pode incluir uma vistoria pelos representantes da (Nome da empresa) e/ou representantes da Autoridade Competente a qualquer momento. O Investigador Principal deve concordar com a vistoria dos registros relacionados ao estudo clínico pelos representantes da Autoridade Competente/(Nome da empresa), e deve permitir aos representantes acesso direto aos documentos originais da Autoridade Competente/(Nome da empresa).
Consentimento Informado
Um formulário principal de informação e consentimento será fornecido ao indivíduo. Antes do início do estudo clínico, o Investigador Principal deve ter aprovação por escrito dos IRB/CNEs ou opinião favorável do formulário do consentimento informado por escrito e quaisquer outras informações por escrito a serem fornecidas aos participantes. A aprovação por escrito do IRB/CNE juntamente com os formulários de consentimento informado/informações sobre o indivíduo devem estar nos arquivos do estudo clínico.
O processo de obtenção do consentimento informado deve estar em conformidade com os requisitos regulatórios aplicáveis, e deve estar de acordo com o GCP e princípios éticos na Declaração de Helsinki. O consentimento informado por escrito deve ser obtido e documentado antes que qualquer procedimento específico do estudo clínico ocorra. A participação no estudo clínico e a data do consentimento informado fornecidos pelo participante devem ser documentados nos arquivos do mesmo.
1. INTRODUÇÃO
O tratamento intensificado de insulina está se tornando rapidamente reconhecido como o regime de escolha. O Estudo de Controle e Complicação do Diabetes confirmou que o tratamento intensificado com insulina pode reduzir a incidência de complicações diabéticas e o atraso na progressão das complicações existentes em pacientes com o diabetes mellitus do tipo 1.
A abordagem padrão atual ao tratamento intensificado com insulina é combinar o uso de uma insulina basal com diversas injeções no horário da refeição de uma insulina de ação rápida. Contudo, essa abordagem tem inúmeras desvantagens.
Uma limitação é a absorção relativamente lenta da insulina injetada subcutaneamente, que não resulta em níveis de insulina fisiológica pós-prandial imediatamente mensuráveis. Além disso, a insulina subcutânea tende a ter uma duração de ação superior ao aumento pós-prandial na glicose, criando assim o risco de hipoglicemia. A fim de equilibrar o efeito pós-prandial imediato desejado com o risco de hipoglicemia pós-prandial tardia, a insulina no horário da refeição é dosada com muito cuidado, de acordo com o tamanho da refeição e a atividade física antecipada, usando sempre algoritmos complexos.
Novas comparações de insulina de ação rápida foram desenvolvidas para a dosagem prandial para se adaptar a esse tipo de regime. Comparações de longa atuação com uma variação muito pequena na atividade estão sendo desenvolvidas como insulinas basais. No entanto, mesmo as comparações atuais de insulina não se parecem com o perfil de entrada muito rápido da liberação de insulina pós-prandial (Figura 2: Liberação Refeição e Figura 3: Segregação 2 Antecipada).
Translation - English ETHICS
Ethics Committee (EC) or Institutional Review Board (IRB)
Documented approval from appropriate Ethics Committees (ECs)/Institutional Review Boards (IRBs) will be obtained for all participating centers/countries prior to clinical trial start, according to ICH GCP, local laws, regulations and organization. When necessary, an extension, amendment or renewal of the EC approval must be obtained and also forwarded to (Company's name). The ECs must supply the sponsor a list of the EC membership, and a statement to confirm that the EC is organized and operates according to GCP, applicable laws and regulations.
Ethical Conduct of the Clinical Trial
The procedures set out in this clinical trial protocol pertaining to the conduct, evaluation, and documentation of this clinical trial, are designed to ensure that the Sponsor and Principal Investigator abide by Good Clinical Practice Guidelines (GCP in the appropriate current version). The clinical trial will also be carried out in accordance with applicable local law(s) and regulation(s). This may include an inspection by (Company's name) representatives and/or Regulatory Authority representatives at any time. The Principal Investigator must agree to the inspection of clinical trial -related records by the Regulatory Authority/(Company's name) representatives, and must allow Regulatory Authority/(Company's name) representatives direct access to source documents.
Informed Consent
A core information and consent form will be provided to the subject. Prior to the beginning of the clinical trial, the Principal Investigator must have the IRB/ECs written approval or favorable opinion of the written informed consent form and any other written information to be provided to subjects. The written approval of the IRB/EC together with the approved subject information/informed consent forms must be in the clinical trial files.
The process of obtaining informed consent must be in accordance with applicable regulatory requirements, and must adhere to GCP and ethical principles in the Declaration of Helsinki. Written informed consent must be obtained and documented before any clinical trial specific procedure takes place. Participation in the clinical trial and date of informed consent given by the subject should be documented in the subject files.
1. INTRODUCTION
Intensified insulin therapy is quickly becoming recognized as the insulin regimen of choice. The Diabetes Control and Complication Trial has confirmed that intensified insulin therapy can reduce the incidence of diabetic complications and delay the progression of existing complications in patients with type 1 diabetes mellitus.
The current standard approach to intensified insulin therapy is to combine the use of a basal insulin with multiple meal time injections of a fast acting insulin. However, this approach has a number of shortcomings.
One limitation is the relatively slow absorption of subcutaneous injected insulin, which does not result in immediately measurable postprandial physiological insulin levels. In addition, subcutaneous insulin tends to have a duration of action exceeding the postprandial rise in glucose, thus creating a risk of hypoglycemia. In order to balance the desired immediate post prandial effect with the risk of late postprandial hypoglycemia, mealtime insulin is dosed very carefully, according to both meal size and anticipated physical activity, often using complex algorithms.
New rapid-acting insulin analogues have been developed for prandial dosing to suit this type of regimen. Long acting analogues with very little variation in activity are being developed as basal insulins. However, even the current insulin analogues do not resemble the very rapid onset profile of post-prandial insulin release (Figure 2 and Figure 3).
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Who we are
Mark-in is a Brazilian company based in São Paulo and Harrogate which has, along the years, supported clients throughout the world not only with their marketing strategies and campaigns but with the daily language barrier they face.
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Our differential
Our translation process starts with marketing research and a brief study of the client's business, in order to understand their business and target consumer. At Mark-in we work together with you to make your business mean to your target exactly what it means to you. Time is critical for every business and with that in mind, we at Mark-in work hard in all time zones in order to deliver quality in the shortest reasonable timeframes.
Companies across the globe frequently need a translation overnight - a contract, report, presentation or simply an e-mail. Because we are internet based, we are always here to help, anytime, including weekends.
Why us?
Mark-in was founded by two Brazilians and an Englishman who brought together their Marketing and language skills in order to provide you with the best choice in the market. We all make mistakes in business and will always make mistakes - this is part of knowledge building and the growth process – however, as a company we stand out simply for being here day and night for our clients to correct mistakes and help solve problems.
Languages
In house we work with Latin and Central American and European Spanish; Brazilian and European Portuguese, and American and British English, however, we have translators collaborating with us worldwide who among other languages translate in German, Italian, French, Japanese and Chinese.
Due to the individual requirements of our clients, pricing begins at 0.08 per word and increases proportionally to the specific project in question, considering file formats and timeframe.
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