Clinical laboratory test definition

Clinical laboratory test or "laboratory test" means a microbiological, serological,
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Clinical laboratory test or "laboratory test" means:
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Clinical laboratory test or “laboratory test” means a microbiological, serological, molecular, chemical, biological, hematological, immunological, immunohematological, cytogenetics, stem cell processing, electron microscopy, histocompatibility, cellular immunology, flow cytometry, or any other test or procedure performed on material derived from or present within a human body which provides information for the diagnosis, prevention, or monitoring treatment of a clinical condition. Clinical laboratory testing encompasses the pre-analytical, analytical, and post-analytical phases of testing.
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Examples of Clinical laboratory test in a sentence

  • Clinical laboratory test values that are out of the normal limits are considered to be abnormal.Handling and shipment of clinical laboratory samples will be outlined in the Lab Manual.

  • Clinical laboratory test values will be considered “TEMA using the criteria defined by the Sponsor (Janssen Research & Development, LLC)” listed in Attachment 2.

  • Clinical laboratory test with possibly drug-related or clinically relevant abnormal values of uncertain causality may be repeated.

  • Clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings will be presented in data listings.

  • Clinical laboratory test results will be reviewed before dosing on Day 1 of each cycle.

  • Clinical laboratory test results (blood chemistry, hematology and urinalysis) will be listed for individual patients.

  • EPA found that reducing sulfur in gasoline will provide significant and immediate health benefits because every gas-powered vehicle on the road built prior to these standards will run cleaner – cutting smog-forming NOx emissions by 260,000 tons in 2018.A more detailed summary of this program is contained in Appendix B.

  • Clinical laboratory test results will be forwarded to individual Investigators (** except as noted below), the Coordination Center and the Clinical Monitor.

  • Clinical laboratory test results and change from baseline will be summarized by time point.

  • Clinical laboratory test results, including results from hematology, chemistry and urinalysis will be listed by patient.


More Definitions of Clinical laboratory test

Clinical laboratory test or “laboratory test” means a microbiological, serological, chemical, hematological, radiobioassay, cytological, biophysical, immunological or other pathological examination which is performed on material derived from the human body, or any other test or procedure conducted by a laboratory or facility which provides information for the diagnosis, prevention or treatment of a disease or assessment of a human medical condition.
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Clinical laboratory test means any: (a) reagent or reagent product comprising a general purpose reagent or any ASR intended for performance of a Clinical Diagnostic procedure; and (b) any method or process for use of such reagent, which is validated by a particular entity internally, solely for use internally by such entity.
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Related to Clinical laboratory test

  • 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.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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).

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • 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.

  • 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.

  • 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.

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • 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 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.

  • Testing laboratory means a laboratory, facility, or entity in the state that offers or performs tests of cannabis or cannabis products and that is both of the following:

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • 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.

  • 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.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Approved laboratory means a laboratory that is listed in the national conference of interstate milk shipments list of sanitation compliance and enforcement ratings distributed by the United States food and drug administration and as approved by the director.

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

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Dental laboratory means a person, firm or corporation

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

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

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