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Good clinical practice

Good clinical practice

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Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for 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...

s involving human subjects.

Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of 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...

 sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associate
Clinical research associate
A clinical research associate is a profession defined by Good clinical practice guidelines .The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract...

s.

ICH GCP overview

  • Guidelines for the investigator
  • Guidelines for the trial sponsor (industrial, academic)
  • Guidelines for the clinical trial protocol
    Clinical trial protocol
    A clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...

     and protocol amendments
  • Guidelines for the Investigator's brochure
    Investigator's brochure
    In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information...


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...

  • 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 :...

  • Directive 2001/20/EC
    Directive 2001/20/EC
    The Clinical Trials Directive is a European Union directive that aimed at...

     (European Union
    European Union
    The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

    )
  • 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...

  • EudraVigilance
    EudraVigilance
    EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...

  • 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)
  • 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)
  • GxP
    GxP
    GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries....

  • Human experimentation in the United States
    Human experimentation in the United States
    There have been numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects....

  • Institutional Review Board
    Institutional review board
    An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

  • Inverse benefit law
    Inverse benefit law
    The Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed...

  • Japan Ministry of Health
  • Medical ethics
    Medical ethics
    Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...

  • Pharmacovigilance
    Pharmacovigilance
    Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...

  • Pharmaceutical company
    Pharmaceutical company
    The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...


External links