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.
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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.
Sample 1Sample 2Sample 3
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.
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Examples of Clinical specimens in a sentence

  • Clinical specimens must include both homozygous wild type and heterozygous genotypes.

  • CDC will post, without change, all relevant comments to Regulations.gov.Please note: Submit all commentsthrough the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.FOR FURTHER INFORMATION CONTACT: Torequest more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A.

  • Clinical specimens are specimens that have been obtained through clinical practice.

  • Clinical specimens: Clinical specimens will be collected as medically indicated and at the discretion of the CS where the proband is being evaluated.

  • 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 tested to support device accuracy must adequately represent the list of cancer mutations with evidence of clinical significance to be detected by the device.

  • Refreshed Five Year Strategic Plan 2008 – 12 page 17 men in Chester-le-Street and 31% for women in Sedgefield).

  • Clinical specimens (animal): Consult with DOH Environmental Public Health Sciences at 360-236-3385.

  • Clinical specimens were obtained from the microbiology diagnostic laboratory at the Fac- ulty of Veterinary Medicine, Warsaw University of Life Sciences-SGGW (Warsaw, Poland).

  • Our aim is to improve the sensitivity and reduce the time required for the detection of mycobacteria in clinical specimens.Methods: Clinical specimens investigated for the presence of mycobacteria were cultivated in the BACTEC MGIT 960 culture system.


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. EXECUTION VERSION
Sample 1
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.
Sample 1
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.
Sample 1

Related to Clinical specimens

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • 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.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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).

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • 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 Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.