Study Stopping Criteria Sample Clauses

Study Stopping Criteria. Study will be stopped and a review of all available safety information is performed by the DSMB, Medical Monitor, and Sponsor if any of the below criteria is met: • ≥1 subject develops a Grade 5 CTCAE adverse event attributed to CRV431 • ≥2 subjects develop a Grade 4 CTCAE adverse event attributed to CRV431 • ≥3 subjects develop the same Grade 3 CTCAE adverse event attributed to CRV431 The study may be restarted depending on the specific AE, relationship to the study drug and with the agreement of the DSMB, Medical Monitor and Sponsor.
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Related to Study Stopping Criteria

  • Exclusion Criteria Subjects fulfilling any of the following criteria are not eligible for participation in this study.

  • Evaluation Criteria 5.2.1. The responses will be evaluated based on the following: (edit evaluation criteria below as appropriate for your project)

  • Project Specific Milestones In addition to the milestones stated in Section 212.5 of the Tariff, as applicable, during the term of this ISA, Interconnection Customer shall ensure that it meets each of the following development milestones:

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Additional RO Review Criteria (1) In addition to the requirements in Subparagraph 34A, the RO must:

  • GEOGRAPHIC AREA AND SECTOR SPECIFIC ALLOWANCES, CONDITIONS AND EXCEPTIONS The following allowances and conditions shall apply where relevant: Where the company does work which falls under the following headings, the company agrees to pay and observe the relevant respective conditions and/or exceptions set out below in each case.

  • Terms of Reference of the Investigator (a) The purpose of the investigator will be to ascertain facts.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Origin Criteria For the goods that meet the origin criteria, the exporter should indicate in Box 8 of this Form, the origin criteria met, in the manner shown in the following table: Circumstances of production or manufacture in the country named in Box 11 of this form: Insert in Box 8

  • Project/Milestones Taxpayer develops and manufactures various products for use in the defense, aerospace and security industries. In consideration for the Credit, Taxpayer agrees to expand its operations at various locations throughout California, including El Segundo, Redondo Beach, Palmdale, Sunnyvale, Woodland Hills, Azusa and Rancho Xxxxxxxx. As part of its expansion, Taxpayer will invest in manufacturing equipment, computer and electrical equipment and make tenant improvements to the above facilities. Additionally, Taxpayer will hire full-time employees as part of its expansion (collectively, the “Project”). Further, Taxpayer agrees to satisfy the milestones as described in Exhibit “A” (“Milestones”) and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of Full- time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” Taxpayer may use the salaries of any of the Full-time employees hired and retained within the required time period. For purposes of calculating the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” the salary of any full-time employee that is not employed by the taxpayer for the entire taxable year shall be annualized. In addition, Xxxxxxxx agrees that any full-time employee hired after the effective date of this agreement that is a “qualified full-time employee” (as defined in RTC section 23636) shall be excluded from the calculation of the net increase of full-time employees required by this Agreement if Taxpayer claims the credit allowed by RTC section 23636.

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