Clinical Trials definition

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 Trials means trials that: 1) have been subjected to independent peer-review of the rationale and methodology; 2) are sponsored by an entity with a recognized program in clinical research that conducts its activities according to all appropriate federal and state regulations and generally accepted standard operating procedures governing the conduct of participating investigators; and 3) the results of which will be reported upon completion of the trial regardless of their positive or negative nature.
Clinical Trials means human studies designed to measure the safety and/or efficacy of the Product. Clinical Studies include Phase I Clinical Trials, Phase II Clinical Trials, and Phase III Clinical Trials.

Examples of Clinical Trials in a sentence

  • Clinical Trials This plan covers clinical trials as required under R.I. General Law § 27-20-60.

  • Cooperative Group includes the National Cancer Institute Clinical Cooperative Group, National Cancer Institute Community Clinical Oncology Program, AIDS Clinical Trials Group, and Community Programs for Clinical Research in AIDS.

  • A Case Series, if Randomized Clinical Trials, Cohort Studies or Case-Control Studies are unavailable;4.

  • This exclusion does not apply to Covered Health Services provided during a Clinical Trial for which Benefits are provided as described under Clinical Trials in Section 6, Additional Coverage Details.

  • An Expert Opinion, if Randomized Clinical Trials, Cohort Studies, Case-Control Studies or Case Series are unavailable.

More Definitions of Clinical Trials

Clinical Trials means human clinical trials conducted up through receipt of Regulatory Approval, including Phase 1 Clinical Trials, Phase 3 Clinical Trials, bioequivalence trials, and/or variations of such trials (for example, phase 2/3 studies). For clarity, the term ‘Clinical Trials’ shall not include Phase 4 Clinical Trials.
Clinical Trials means Phase I Trials, Phase II Trials, Phase III Trials, Phase IV Trials, and/or variations of such trials (for example, phase II/III studies).
Clinical Trials means tests and studies in human subjects or patients that are required to obtain, maintain, or sustain Regulatory Approval in a country in the Territory.
Clinical Trials means Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Phase 4 Trials, and/or variations of such trials (for example, Phase 3/4).
Clinical Trials means any administration of Licensed Products to humans for the purpose of demonstrating the safety or efficacy of the Licensed Product.