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  2. Clinical trials in India - Wikipedia

    en.wikipedia.org/wiki/Clinical_trials_in_India

    Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .

  3. Indian Council of Medical Research - Wikipedia

    en.wikipedia.org/wiki/Indian_Council_of_Medical...

    The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare. [2] [3] In 2007, the organization established the Clinical Trials Registry - India, which is India's national registry for clinical trials. [4]

  4. Clinical Trials Registry – India - Wikipedia

    en.wikipedia.org/wiki/Clinical_Trials_Registry...

    The CTRI requests all the information which the World Health Organization recommends for clinical trial registries. [8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs ...

  5. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.

  6. Swasthya Adhikar Manch v. Union of India - Wikipedia

    en.wikipedia.org/wiki/Swasthya_Adhikar_Manch_v...

    Any company seeking approval to do clinical trials has to report the risks and benefits to patients for the research. [5] As a result of the ruling in 2014 India published new requirements for clinical trials. [6] The Supreme Court reprimanded an organization for not compensating victims who were injured. [7]

  7. List of clinical trial registries - Wikipedia

    en.wikipedia.org/wiki/List_of_clinical_trial...

    The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]

  8. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    Clinical – efficacy and safety (clinical trials) Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements.

  9. Pharmacovigilance Programme of India - Wikipedia

    en.wikipedia.org/wiki/Pharmacovigilance...

    The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research. [5] Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India.