Regulatory Approval (of clinical trial)

Regulatory Approval (of clinical trial)
Разрешение регуляторных органов
Разрешение уполномоченных регуляторных органов на проведение клинического испытания, даваемое после рассмотрения соответствующим образом представленной документации.

English-Russian glossary of clinical practice. 2002.

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  • Clinical trial — Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be… …   Wikipedia

  • Clinical trial management — A clinical trial is the application of the scientific method to human health. Since such trials require the use of human test subjects and can severely impact the well being of the subjects, as well as treatments of other people and large amounts …   Wikipedia

  • Clinical Trial Portal — Not to be confused with Clinical Trials Registry or Clinical Trial Management System. A clinical trial portal (also known as clinical portal or clinical study portal) is a web portal or enterprise portal that primarily serves sponsors and… …   Wikipedia

  • Clinical trial management system — A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains… …   Wikipedia

  • Clinical Trial Management System — A Clinical Trial Management System, also known as CTMS , is a customizeable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains… …   Wikipedia

  • Regulatory requirement — Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the …   Wikipedia

  • Clinical research — is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving… …   Wikipedia

  • Clinical research coordinator — The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of the Principal Investigator (PI). Good Clinical Practices Principles have been defined by Madelene… …   Wikipedia

  • Clinical data management system — A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the… …   Wikipedia

  • List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T …   Wikipedia

  • H5N1 clinical trials — are clinical trials concerning H5N1 vaccines. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans. [ [http://clinicaltrials dev.ifpma.org/ IFPMA glossary] ] Current Status of …   Wikipedia


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