Clinical Event definition

Clinical Event means the occurrence of at least one patient being treated under the Phase II b clinical trial sponsored by the Company pursuant to Protocol VEGF2-CAD-CL-007, entitled “A Multicenter, Randomized, Double-Blind, Dose Ranging Placebo-Controlled Study Evaluating Defined Doses Of Percutaneously Delivered Via Boston Scientific Corporation Stiletto(tm) Endocardial Injection Catheter pVGI.1 (VEGF2) (Placebo, 20, 200, Or 800µG) In Patients With Class III Or IV Angina.
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Clinical Event means any action, or any adverse inspection or audit finding that would reasonably be expected to result in an action, by a governmental authority to place a clinical hold order on, or otherwise terminate, suspend or restrict in any material respect, any ongoing clinical trial conducted by MyoKardia or any of its subsidiaries with respect to any mavacamten, danicamtiv, MYK-224, LUS-1, ACT-1 and the early stage targets covered by MyoKardia’s genetic cardiomyopathy programs (each, a “Product”) which would reasonably be expected to result in a material delay or material impairment in the ability of MyoKardia to obtain any regulatory authorizations from any governmental authority relating to such Product. MyoKardia (a) will (i) give Parent the opportunity to participate in, but not control, the defense and settlement of any Transaction Litigation against MyoKardia or its directors relating to the Merger Agreement or the Transactions (to the extent that the attorney-client privilege is not undermined or otherwise adversely affected) and (ii) keep Parent reasonably informed with respect to the status thereof, and (b) will not offer or propose to settle, settle or agree to settle any such Transaction Litigation without Parent’s prior written consent (which will not be unreasonably withheld, conditioned or delayed).Lawsuits arising out of or relating to the Offer, the Merger or any other transactions referenced herein may be filed in the future.
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Clinical Event means any action, or any adverse inspection or audit finding that would reasonably be expected to result in an action, by a Governmental Authority to place a clinical hold order on, or otherwise terminate, suspend or restrict in any material respect, any ongoing clinical trial conducted by the Company or any of its Subsidiaries with respect to any Product which would reasonably be expected to result in a material delay or material impairment in the ability of the Company to obtain any Regulatory Authorizations from any Governmental Authority relating to such Product.
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Examples of Clinical Event in a sentence

  • Vertex shall provide CRISPR with reasonably detailed updates, in accordance with the notice procedures set forth in the Pharmacovigilance Agreement, about any such Specified Clinical Event.

  • For this review, the reviewer utilized both the study reports, including the details of the proceedings of the SC, Clinical Event Review Committee [CERC] and DSMC in the appendices, as well as the data sets provided to us by the sponsor.

  • Notwithstanding anything to the contrary in this Agreement or the Pharmacovigilance Agreement, Vertex will promptly notify CRISPR (and, in any event, within [***] Business Day), in accordance with the notice procedures set forth in the Pharmacovigilance Agreement, after Vertex or any Affiliate thereof becomes aware of the occurrence of any Specified Clinical Event (as hereinafter defined), and Vertex will provide CRISPR with reasonably detailed information regarding such Specified Clinical Event.

  • Clinical events are ascertained by a Clinical Event Ascertainment Committee led by Dr. Fernando Arós of the Vitoria group.

  • Incident Occurs Does incident feature on list for Significant Clinical Event Analysis (SCEA)?Record Incident in Electronic Incident Reporting System within 24 hours of occurrence and send to Line Manager/Deputy for verificationInform General Manager/Head of Nursing/Clinical Service ManagerGREENAMBERREDLine Manager/Deputy to verify within 72 hours of receipt, complete Executive Summary and fulfil any external reporting requirementsHON/CSM to conduct assessment and analysis.

  • Copies of the “Critical Clinical Event Form” shall also be forwarded to the staff listed in F.

  • Failure of the student to submit a Clinical Event Report for an unusual clinical event within 48 hours of the event, or the discovery of the event, may result in possible probation and/or dismissal from the program.

  • Types of Incident Reviews6.1 Significant Clinical Event Analysis (SCEA)These focus on significant clinical incidents which have an impact of permanent psychological and/or physical harm or death on one or many patient(s).

  • Clinical events will be ascertained by a Clinical Event Ascertainment Committee led by Dr. Fernando Arós of the Vitoria group.

  • In the event that the public announcement of the Clinical Event does not occur prior to the termination of the Option Period, the Escrow Agent shall return the Escrow Funds to the Purchasers as provided in the Escrow Agreement.

Related to Clinical Event

  • Medical event means an improper administration of radiation or radioactive material to a patient or human research subject that requires reporting to the department.

  • 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 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 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.

  • 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 II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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.

  • 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 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 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • 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.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • 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).

  • Emergency Medical Event means an event wherein an Insured Person’s medical condition and situation are such that, in the opinion of the Company’s affiliate or authorized vendor and the Insured Person’s treating physician, the Insured Person requires urgent medical attention without which there would be a significant risk of death, or serious impairment and adequate medical treatment is not available at the Insured Person’s initial medical facility.

  • 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).

  • Milestone Event has the meaning set forth in Section 1.11(a).

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • 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 evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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;

  • Sentinel event means a type of critical incident that is an unexpected occurrence involving the death or serious physical or psychological injury to a person served, staff member, or visitor, or risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes a variation in approved processes which could carry a significant chance of a serious adverse outcome. These events signal the need for immediate investigation and response. Sentinel events include, but are not limited to, suicide, homicide, assault and other forms of violence, including domestic violence or sexual assault, and adverse drug events resulting in serious injury or death. Sentinel events include occurrences that take place at the facility and/or during the delivery of services, as well as suicide and unintentional drug overdose deaths that occur at any time while a person receiving outpatient services is an active client and within seventy-two (72) hours of discharge from inpatient and residential settings, including sites certified under Chapter 23 of this Title.

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

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.