Clinical specimens definition

Clinical specimens means materials taken from humans or animals, in as far as the samples taken from animals are shared by originating countries/laboratories with the WHO GISRS. These include specimens collected from the respiratory tract (for example, swabs and aspirated fluid), and also blood, serum, plasma, faeces, and tissues, for diagnostic purposes, detection of pathogens and further characterization, study or analysis.
Clinical specimens means biological materials such as swabs and aspirated fluid, blood, serum, plasma, faeces, and tissues, collected from humans/[and non-human sources/animals] for diagnostic purposes, study or analysis.
Clinical specimens means materials collected from humans, generally for examination, diagnostic confirmation, study or analysis. For influenza, most commonly, clinical specimens are taken from the respiratory tract (for example, swabs and aspirated fluid) but they can be from other locations.

Examples of Clinical specimens in a sentence

  • Clinical specimens received into the EP lab for analysis are pre-accessioned for analysis by assigning each one a unique code number based on the calendar year (four digits) + the Julian Day (three digits) + a four digit number for the day’s sample, for a total of 11 digits.

  • Clinical specimens received into the Trace Elements Lab for analysis are pre-accessioned for analysis by assigning each one a unique code number based on the calendar year (four digits) + the Julian Day (three digits) + a four digit number for the day’s sample, for a total of 11 digits.

  • Clinical specimens consisted of nasopharyngeal swabs from symptomatic individuals collected in UTM that were all archived frozen in the previous four years.

  • Clinical specimens were obtained from three government laboratories that characterized the samples for SARS-CoV-2 by the use of an EUA authorized SARS-CoV-2 kit.

  • Clinical specimens and nucleic acid samples are tracked locally by an inventory sheet that includes primary specimen barcode, primary derivative nucleic acid barcode, two (or more) subaliquot nucleic acid barcodes, nucleic acid concentration (determined by A260), and physical location of each specimen/sample.

  • Clinical specimens are added as they are received in the laboratories from the wards or operation theatres or autopsy rooms.There is separate Medical Education Unit for conducting educational research, teaching, providing service and career development of academic staff.

  • Clinical specimens were collected from Chukwuemeka Odumegwu Ojukwu University Teaching Hospital (COOUTH) Awka (formerly called Amaku General Hospital) which is the only tertiary hospital in Awka the capital of Anambra State between December 2018 and May 2019.

  • See https://osp.od.nih.gov/wp- content/uploads/GDS_Points_to_Consider_for_Institutions_and_IRBs.pdf.38 Clinical specimens are specimens that have been obtained through clinical practice.the effective date of this Policy and that lack consent for research use and data sharing, investigators should provide a justification in the funding request for their use.

  • Clinical specimens from patients should have RVP and FDA-authorized SARS-CoV-2 molecular assay testing performed, ideally by a state or local public health laboratory.

  • Clinical specimens were used to assess analytical accuracy, precision and confirmation of the estimated limit of detection (LoD), and evaluate sample stability.


More Definitions of Clinical specimens

Clinical specimens. Clinical Specimens mean all clinical specimens, samples, tissues, fluid, and other biological and pharmaceutical materials generated or obtained in connection with this Agreement or the MTA, and modifications thereof.
Clinical specimens means materials collected from humans, generally in order to confirm a diagnosis. For influenza, most commonly, clinical specimens are taken from the respiratory tract (for example, swabs and aspirated fluid) but they can be from other locations. Clinical specimens can be frozen and stored for later use.
Clinical specimens means materials taken from the respiratory tract (for example, swabs and aspirated fluid), and also blood, serum, plasma, feces, and tissues, collected from humans/[and non- human sources/animals] for diagnostic purposes, study or analysis.

Related to Clinical specimens

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Medical Specialist means any medical practitioner who is vocationally registered by the Medical Council under the Health Practitioners Competence Assurance Act 2003 in one of the approved branches of medicine and who is employed in either that branch of medicine or in a similar capacity with minimal oversight.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing Process means any process for—

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.