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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 .
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]
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 ...
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.
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
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]
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]
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.