Clinical Failure definition

Clinical Failure means any decision by the Customer, in its sole discretion, (a) [**]
Sample 1Sample 2
Clinical Failure means a Product that has failed to meet the criteria set forth in Exhibit 1.43 and, as a result, for which AstraZeneca has discontinued Development and (if applicable) Commercialization.
Sample 1Sample 2
Clinical Failure means any of the following: (i) receipt of a written order by a Regulatory Authority to cease development in a clinical trial in one or more Indications of the Product; or
Sample 1Sample 2

Examples of Clinical Failure in a sentence

  • Refer to individual course syllabi for course specific information.2. If the student misses one or more than one clinical day per clinical/lab/simulation the student may anticipate recommendation for removal from the program due to the inability to meet course objectives.3. Clinical Failure - Unsafe practice in the clinical area; any act that is harmful or potentially detrimental to the client.

  • Unsafe Clinical Practice – Probation and FailureStudents who exhibit unsafe clinical practice with the potential to impact patient health, welfare, and/or safety will be placed on Clinical Probation or immediately recommended for Clinical Failure.

  • In either the case of Clinical Probation or Clinical Failure, the Committee on Student Promotions will define the conditions under which the student may or may not be allowed to progress to further clinical courses.

  • Students wishing to appeal a Clinical Failure decision may do so by following the steps outlined in the Grade Appeal Protocol.

  • The decision whether a given incident or pattern warrants Clinical Failure is the sole discretion of Jefferson College of Nursing.

  • The decision whether a given incident or pattern warrants assignment of Clinical Probation or Clinical Failure is the sole discretion of Jefferson College of Nursing faculty.

  • Students failing to remediate satisfactorily and unable to meet the expected student learning outcomes, will receive a Clinical Failure.

  • McDonough, M.J., Feldmeier, J.J., Parsai, E.I., Dobelbower, R.R., and Selman, S.H., Salvage External Beam Radiotherapy For Clinical Failure After Cryosurgery For Prostate Cancer, Int.

  • Incidence, Etiology, Timing And Risk Factors For Clinical Failure In Hospitalized Patients With Community-Acquired Pneumonia.

  • Fabrication of any clinical or College record will result in program dismissal with ineligibility for readmission (See Clinical Failure Policy).


More Definitions of Clinical Failure

Clinical Failure means the event of [***] or [***] the [***] of a [***] for [***] including but not limited to, a [***] provided that [***] of the [***] for all indications. In the case of [***] the [***] or the failure to [***] and / or [***] shall be deemed a Clinical Failure, even if [***] provided that such [***] will [***] in a [***].
Sample 1Sample 2
Clinical Failure means the occurrence of either, (a) the Parties mutually agreeing through the JSC (i) [*] and (ii) [*], or (b) [*].
Sample 1
Clinical Failure means, as determined by Xxxxx acting reasonably, that either (a) [***] or (b) [***].
Sample 1
Clinical Failure means with respect to the [***].
Sample 1
Clinical Failure means the failure to achieve the specified primary efficacy endpoint of a Clinical Study undertaken for any TO Product in the Field in the Shionogi Territory where such Clinical Study is intended primarily in the demonstration of product efficacy.
Sample 1
Clinical Failure means any of the following: (i) receipt of a written order by a Regulatory Authority to cease development in a clinical trial in one or more Indications of the MT203 Product; or (ii) a determination [***] by [***] or [***] (1) that the continued development of the MT203 Product would not be ethical or in the best interest of patient safety or (2) that the MT203 Product has failed to achieve the primary efficacy endpoints [***] based upon an applicable final or interim study report.
Sample 1

Related to Clinical Failure

  • Technical Failure means the discontinuation of Development or Commercialization of a Product for technical, scientific, medical or regulatory reasons, including, but, not limited to, unacceptable preclinical toxicity, demonstration of a side effect profile significantly worse than currently marketed products, or inability to manufacture in an acceptable purity or for an acceptable price.

  • Supply Failure has the meaning given to it in Section 7.5.2 (Supply Failure).

  • Epidemic Failure means a series of repeating failures or defects resulting in at least a 0.5% failure rate for the same Product or Material during any twelve-month period.

  • MI Failure means when an MI report: a) contains any material errors or material omissions or a missing mandatory field; or b) is submitted using an incorrect MI reporting Template; or c) is not submitted by the reporting date(including where a Nil Return should have been filed);

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Persistent Failure means any two (2) or more failures by the Supplier in any rolling period of twelve (12) months to comply with obligations in respect of the Contract Services under the Contract;

  • Listing Failure Event means that:

  • GEP Failure means Seller’s failure to produce Delivered Energy in an amount equal to or greater than the Guaranteed Energy Production amount for the applicable Performance Measurement Period.

  • Service Level Failure means a failure to perform the Software Support Services fully in compliance with the Support Service Level Requirements.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Reporting Failure has the meaning set forth in Section 2.4.

  • 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.

  • Service Failure means a failure by the Contractor to provide the Services in accordance with any individual service level described above (measured on a monthly/quarterly/annual basis)

  • Consistent Failure means any of:

  • 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 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 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.

  • 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.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 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 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.

  • 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.

  • Listing Failure means the situation where the Bonds have not been listed on the corporate bond list of Nasdaq Stockholm (or any other Regulated Market) within sixty (60) calendar days after the Issue Date.

  • 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.