Clinical Trigger definition

Clinical Trigger means a criterion (or set of criteria) identified in the Clinical Trigger Card that, upon its occurrence, requires Hospital to refer a Death or Imminent Death to OneLegacy.
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Examples of Clinical Trigger in a sentence

  • Hospital will utilize the Clinical Trigger Card to identify when a referral should be made.

  • The Parties will mutually agree to Clinical Trigger criteria that must, pursuant to CMS Conditions, effectively promote the opportunity for (i) OneLegacy to determine a potential donor’s suitability for organ, eye, and/or tissue donation, (ii) the family of each potential donor to be informed of its options regarding donation, and (iii) Hospital to maintain each potential donor while necessary testing and placement of potential organ, eye, and/or tissue donation(s) take place.

Related to Clinical Trigger

  • 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 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.

  • 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 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 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.