Part B Secondary Endpoints Sample Clauses

Part B Secondary Endpoints. CORE Study:  Change in sweat chloride from Baseline to all post-baseline visits  Change in BMI and body weight from Baseline to all post-baseline visits  Change in sputum microbiome and markers of inflammation from Baseline to selected post-baseline visits. Other Evaluations for all Sub-Studies:  The core and sub-studies will be linked so that associations between primary and secondary endpoints from each sub-study and clinical parameters (e.g., spirometry, weight, and sweat chloride) may be explored. GIFT Sub-Study  Glucose/Insulin Functional Testing: o Percent in each OGTT category (Section 8.1.4) at each visit, and change in category from Baseline to all subsequent visits o HbA1c at each Visit and change from Baseline to all subsequent visits o For subjects on insulin therapy, insulin dose (units/kg/day) at each visit, and change in dose from Baseline to all subsequent visits.  Gastro-intestinal Functional Testing Sub-Study: o Percent with positive breath test by Fridge Criteria at Baseline and Visit 5 o Mean fasting hydrogen levels (ppm) at Baseline and Visit 5 and change from Baseline to Visit 5 among those with measures at both time points (i.e., positive breath test at Baseline). pH-Pill Sub-Study  Change in the small intestinal pH during the initial 120 minutes of small bowel transit, post gastric emptying  Change in time to reach and sustain intestinal pH above 5.5 from Baseline to Visit 5  Change in the functional model of the pH curve from Baseline to Visit 5. MBW/FENO Sub-Study  Change in LCI from Baseline to all subsequent visits  Percentage of subjects producing research quality measurements at all visits  Change in FENO from Baseline to all subsequent visits. MCC Sub-Study: The following changes will be examined between Baseline and Visit 5:  Change in average whole lung clearance between 0 and 30 minutes (AUC30) and between 0 and 90 minutes (AUC90)  Change in AUC60 in the peripheral lung compartment  Change in AUC60 in the central lung compartment  Change in cough clearance (average clearance measured between 60 – 90 minutes after isotope inhalation)  Change in whole lung clearance measured through 24 hours.
Sample 1
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Related to Part B Secondary Endpoints

  • HHS Single Audit Unit will notify Grantee to complete the Single Audit Determination Form If Grantee fails to complete the form within thirty (30) calendar days after receipt of notice, Grantee maybe subject to sanctions and remedies for non-compliance.

  • Secondary Systems The Developer and Connecting Transmission Owner shall each cooperate with the other in the inspection, maintenance, and testing of control or power circuits that operate below 600 volts, AC or DC, including, but not limited to, any hardware, control or protective devices, cables, conductors, electric raceways, secondary equipment panels, transducers, batteries, chargers, and voltage and current transformers that directly affect the operation of Developer or Connecting Transmission Owner’s facilities and equipment which may reasonably be expected to impact the other Party. The Developer and Connecting Transmission Owner shall each provide advance notice to the other Party, and to NYISO, before undertaking any work on such circuits, especially on electrical circuits involving circuit breaker trip and close contacts, current transformers, or potential transformers.

  • Use of the Secondary Recall List (a) After the exhaustion of the Agency Layoff List for a specific classification within a geographic area, the Secondary Recall List shall be used to fill all positions within a specific classification and geographic area consistent with Section (c) above, until such secondary list is exhausted.

  • Placement on the Secondary Recall List (a) Regular status employees who are separated from the service of the State in good standing (meaning no record of economic disciplinary sanctions in his/her personnel file) by layoff or transferred outside State government due to intergovernmental transfer shall, in addition to their right to be placed on the Agency Layoff List, be given the option of electing placement on the Secondary Recall List by geographic area for other AFSCME-represented bargaining units which utilize the same or successor classification from which they were laid off. The term of eligibility of candidates placed on the list shall be two (2) years from the date of layoff. When an employee is prohibited from participating in the secondary recall process due to the presence of an economic disciplinary sanction in his/her personnel file, that employee may request and shall be placed on the Secondary Recall List for the remainder of the two (2) years eligibility following layoff once the discipline has remained in the file for the length of time required by the agency’s contract.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

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

  • PROCEDURES AND/OR CRITERIA FOR COURSE ARTICULATION a. Complete the ROP Careers with Children course at Freedom High School with a grade of “B” or better.

  • Schedule for Completing Agreement Closeout Activities Provide All Draft and Final Written Products on a CD-ROM or USB memory stick, organized by the tasks in the Agreement. Products: • Final Meeting Agreement Summary (if applicable) • Schedule for Completing Agreement Closeout Activities • All Draft and Final Written Products

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Contractor hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace. The Contractor will give written notice to the State within ten (10) days after receiving actual notice that the Contractor, or an employee of the Contractor in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of contract payments, termination of this Contract and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in this Contract is in excess of $25,000.00, the Contractor certifies and agrees that it will provide a drug-free workplace by:

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