Clinical investigator
Encyclopedia
A clinical investigator involved in a clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

 is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.

See also

  • Clinical site
    Clinical site
    A clinical site is a medical facility staffed with a clinical investigator and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to...

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • Drug development
    Drug development
    Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...

  • Data monitoring committees
    Data Monitoring Committees
    A Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...

  • Food and Drug Administration
    Food and Drug Administration
    The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

     (FDA)
  • European Medicines Agency
    European Medicines Agency
    The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...

     (EMEA)
  • Japan Ministry of Health
  • European Forum for Good Clinical Practice
    European Forum for Good Clinical Practice
    The European Forum for Good Clinical Practices is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe...

     (EFGCP)
  • American Society for Clinical Investigation
    American Society for Clinical Investigation
    The American Society for Clinical Investigation, or ASCI, established in 1908, is one of the nation's oldest and most respected medical honor societies.-Organization and Purpose:...

     (ASCI)
  • European Society for Clinical Investigation
    European Society for Clinical Investigation
    The European Society for Clinical Investigation was founded on February 12, 1967 as a pan-European society of clinicians and scientists with a genuine interest in uncovering disease mechanisms...

    (ESCI)

External links

The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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