#FREE CLINICAL TRIALS CODE#
Current sponsor code The current code in use by the sponsor for an active substance. Comparison of two (or more) treatments in which patients are switched to the alternative treatment after a specified period of EMA/534108/2010 /13ģ Glossary of s used in EU Clinical Trials Register time.
#FREE CLINICAL TRIALS TRIAL#
Name of the country where the holder was granted the Marketing Authorisation of the actual IMP to be used in the clinical trial in the member state concerned by the application. Country(s) where clinical trials are planned to be conducted. The reference treatment can be, for example, a placebo, a product known to be effective, a surgical procedure, or a different dose of the same product. In a controlled trial, the tested product is compared to a reference treatment. The unit of measurement used for the concentration of the active substance.
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A regulatory agency in an EU Member State or for medical devices, a Competent Authority is the organization with the authority to act on behalf of the government of a Member State to ensure that all medical devices meet the essential requirements laid down in the Directives prior to marketing authorisation. active control) or placebo, used as a reference in a clinical trial. An investigational or marketed product (i.e. Ref: DIRECTIVE 2001/20/EC An ATIMP (Advanced Therapy Investigational Medicinal Product) involving a medical device.
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Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. The code is non-expressive and is intended to fulfil a data field in various electronic submission types. An eight digit unique numeric code assigned to a MedDRA term. Procedural advice on the provision of scientific recommendation on CAT (classification of advanced therapy medicinal products).Ģ Glossary of s used in EU Clinical Trials Register CE mark Classification code (MedDRA) Clinical Trial (CT) Combination ATIMP Comparator Competent Authority (CA)/ National Competent Authority (NCA) Also referred as National Medicine Regulatory Authorities Concentration unit Controlled Countries in which trial sites are planned Country which granted the Marketing Authorisation Cross over European conformity Marking: A mandatory European marking for products falling under one of the New Approach Directives (including medical devices, but excluding cosmetics, chemicals, pharmaceuticals, foodstuffs) to indicate conformity with the health and safety requirements set out in European Directive. A service of the American Chemical Society that indexes and compiles abstracts of worldwide chemical literature called Chemical Abstracts. c CAS number CAT classification Chemical Abstract Services (CAS) are unique numerical identifiers for chemical elements, compounds, polymers, biological sequences, mixtures and alloys.
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Biotechnology is the application of biological organisms, systems or process to manufacturing of pharmaceuticals. b Bioequivalence study Biotechnology Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two preparations of a Medicinal Product. International system for classification of medicines maintained by World Health Organisation. Ref: DIRECTIVE 2001/20/EC Anatomic, therapeutic, chemical. Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Advance Therapy Investigational Medicinal Products are medicinal products involving cell or gene therapy or tissue engineering. Glossary of s used in EU Clinical Trials Register a Active Substance Active substance of biotechnological origin Active substance of chemical origin Adolescents (12-17 years) Adults (18-64 years) Advanced Therapy IMP (ATIMP) Adverse Event ATC An active substance (AS), is the substance in a medicinal product that is biologically active A product that contains an active substance of biological or biotechnological origin A product that contains an active substance of chemical origin Subjects are aged 12 to less than 18 years. They are not intended as the regulatory definitions and should not be used or substituted for the regulatory definitions and guidelines. 1 EU Clinical Trials Register Disclaimer: The explanations are provided for the benefit of public users of the system and to enhance general understanding of terms used.