STUDY ASSESSMENTS Sample Clauses

STUDY ASSESSMENTS. Subjects randomized to BA058 Injection 80 µg/Placebo in Study BA058-05-003 will receive alendronate at a dose of 70 mg once per week for a total of 24 months. The assessments performed at each study visit are displayed in the Schedule of Visits and Procedures in Appendix 14.1. Appendix 14.2 provides a more detailed schedule of the study procedures by study visit with a suggested order of procedure conduct. Exact procedures for centrifuging, storage, and shipping of laboratory samples will be detailed in a separate document. The actual time of each blood collection will be recorded on the appropriate source documents and in the eCRF. Study-specific assessments are to be conducted only after the subject has provided written informed consent to participate in this study. The study assessments are described in more detail in Section 7.1 below.
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STUDY ASSESSMENTS. Physical examinations, xxxxx xxxxx, ECGs, clinical labs (hematology, chemistry, urinalysis), serum total and ionized calcium, phosphorus, thyroid hormones, adverse events, and local tolerability. · Pharmacokinetics: serial PK samples taken on a subgroup of patients. · Pharmacodynamics (i.e., biochemical markers of bone metabolism and resorption): procollagen 1 carboxy terminal propeptide (PICP) bone specific alkaline phosphatase (BSAP), osteocalcin, cathepsin K, urine N telopeptide (NTX) urinary free deoxypyridinoline, nephrogenic cAMP level, urinary calcium excretion, creatinine clearance, vitamin D, intact PTH (1-84). · Efficacy: measure a reduction in the proportion of patients with new vertebral fractures following treatment. Other assessments changes in BMD (lumbar spine, hip, forearm). · Anti-BA058 antibody.
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STUDY ASSESSMENTS. Physical examinations, xxxxx xxxxx, ECGs, clinical labs (hematology, chemistry, urinalysis), serum total and ionized calcium, phosphorus, thyroid hormones, adverse events, and local tolerability. · Pharmacokinetics: serial PK samples taken on a subgroup of patients. · Pharmacodynamics (i.e., biochemical markers of bone metabolism and resorption): [*]. · Efficacy: measure a reduction in the proportion of patients with new vertebral fractures following treatment. Other assessments changes in BMD (lumbar spine, hip, forearm). · Anti-BA058 antibody.
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STUDY ASSESSMENTS. ‌ All data and images taken from the study will be saved and shared to the Sponsor via a data- protected platform.
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STUDY ASSESSMENTS. This is a noninterventional study. Standard of care at many institutions include the following assessments.
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STUDY ASSESSMENTS. The research component of the Community Pediatric Acceptability Study (CPAS) study included the following data collection instruments for parents (Appendix II):
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STUDY ASSESSMENTS. 11.4.1 Data control measures In order to assure adequate control and provide study data that are consistent and of the highest quality, the following measures are employed:
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STUDY ASSESSMENTS. All clinical laboratory assessments will be conducted locally at the clinical site facilities.
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STUDY ASSESSMENTS 
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Related to STUDY ASSESSMENTS

  • Risk Assessments a. Risk Assessment - Transfer Agent shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats occurring and the impact of those threats upon the Transfer Agent organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Joint Assessment If the Building is not separately assessed, Real Property Taxes allocated to the Building shall be an equitable proportion of the Real Property Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be determined by Lessor from the respective valuations assigned in the assessor's work sheets or such other information as may be reasonably available. Lessor's reasonable determination thereof, in good faith, shall be conclusive.

  • Taxes; Assessments The real estate taxes shall be prorated. Seller shall pay real estate taxes which are payable during the year in which Closing occurs, and taxes payable during the succeeding year, prorated to the date of Closing. Buyer shall assume and pay all subsequent taxes. If at the time of closing the tax xxxx for the Real Estate for the succeeding year has not been issued, taxes payable shall be computed based on the last tax xxxx available to the closing agent. The succeeding year’s tax xxxx, because of recently constructed improvements, annexation, reassessment, or similar items may greatly exceed the last tax xxxx available to the closing agent.

  • Environmental Assessments Foreclose on or take a deed or title to any commercial real estate without first conducting a Phase I environmental assessment of the property or foreclose on any commercial real estate if such environmental assessment indicates the presence of a Hazardous Substance in amounts which, if such foreclosure were to occur, would be material.

  • Assessments There are no pending or, to Borrower’s knowledge, proposed special or other assessments for public improvements or otherwise affecting any Individual Property, nor are there any contemplated improvements to any Individual Property that may result in such special or other assessments.

  • No Joint Assessment Borrower shall not suffer, permit or initiate the joint assessment of the Property (a) with any other real property constituting a tax lot separate from the Property, and (b) which constitutes real property with any portion of the Property which may be deemed to constitute personal property, or any other procedure whereby the lien of any taxes which may be levied against such personal property shall be assessed or levied or charged to such real property portion of the Property.

  • Environmental Assessment Buyer shall have the right for a period commencing upon execution of this Agreement by both parties and ending on November 28, 2012, to conduct an environmental assessment of the Assets, at Buyer’s sole risk, liability and expense. Seller shall make available to Buyer, during the environmental assessment period described above, Seller’s historical files regarding prior operations on the Assets, and provide Buyer and its representatives with reasonable access to the Assets to conduct the environmental assessment. Buyer shall provide Seller three (3) days prior written notice of a desired date(s) for such assessment and Seller shall have the right to be present during any assessment and, if any testing is conducted pursuant to Seller’s express prior written consent, Seller may require splitting of all samples. Notwithstanding any other provision of this Agreement to the contrary, Buyer shall not have the right to drill any test, monitor or other xxxxx or to extract samples of any air, soil, water or other substance from the Assets without Seller’s express prior written consent. If Buyer proposes a reasonable request to drill a test well or extract a sample pursuant to a systematic and customary procedure for the assessment of the environmental condition of the Assets and Seller refuses to grant its consent to such a well or sampling, then Buyer shall have the right, for a period of seventy-two (72) hours following notification of Seller’s refusal to consent, to deliver written notice to Seller of Buyer’s election to exclude from this transaction the portion of the Assets affected by such proposed test well or sample, and the Purchase Price shall be adjusted accordingly by the Allocated Value of such portion of the Assets so excluded. Under no circumstances whatsoever shall Seller ever be obligated to grant its consent to any such test xxxxx or sampling proposed by Buyer, and Buyer’s sole and exclusive remedy for any refusal by Seller to grant its consent shall be the limited right contained in the preceding sentence to exclude the affected Assets from the transactions contemplated by this Agreement. If Buyer fails to exercise the right to exclude such Assets by written notice to Seller delivered prior to the expiration of the seventy-two hour period described above, then Buyer shall be conclusively deemed to have waived such right and shall be obligated to purchase the affected Assets without conducting such testing or sampling or any adjustment of the Purchase Price unless otherwise provided in this Agreement.

  • Phase II A small portion of the work for the Phase II modifications to the Plattsburgh Substation will be performed by Transmission Owner, and the remainder will be performed by Clinton and Xxxxxxxxx. A detailed definition of the specific scope for Transmission Owner and Clinton and Xxxxxxxxx including interface points shall be defined during the design phase and, as such documents become available, copies will be delivered to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The full scope includes the installation of wave traps, CCVT’s and modifications and/or additions to relaying on the MWP-1 and MWP- 2 lines. These lines will be reconfigured at the completion of Phase II to connect to Xxxxx and Xxxxxxx Substations on MWP-1 and the Xxxx Substation on MWP-2. Clinton and Xxxxxxxxx will design the upgrades and purchase the materials based on the outline specification that was prepared and issued by Transmission Owner. The work to be performed by Clinton and Xxxxxxxxx will include both the materials for the exterior and interior installations and items for Transmission Owner installation inside the control building in existing relay panels and communication racks. In addition, Clinton and Xxxxxxxxx will be responsible for the exterior and interior construction work and will provide construction management services in coordination with Transmission Owner. The civil design for the foundations and the electrical design for the cable runs to the control room will be designed by, as approved by Transmission Owner, and installed under the supervision and control of Clinton and Xxxxxxxxx. The equipment will be selected and procured in accordance with the specifications developed during the detailed engineering phase, copies of which shall be furnished to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The construction of the foundations, structures, wave traps, CCTV and cable runs into the control building to the termination cabinets will be completed by Clinton and Xxxxxxxxx. The work at the Plattsburgh Substation will be installed under Transmission Owner’s CPP-1. Transmission Owner will provide Protection and Controls Engineering, install and terminate wiring from the termination cabinets to the control panels and relays, install relays and equipment in the existing panels, and will commission such work inside the 230kV control building. Transmission Owner will develop the communications protocols and data flow over the circuits.

  • TAXES, ASSESSMENTS AND UTILITIES (A) Lessee shall be liable and agrees to pay the charges for all public utility services rendered or furnished to the Leased Premises, including heat, water, gas, electricity, sewer, sewage treatment facilities and the like, all personal property taxes, real estate taxes, special assessments, and municipal or government charges, general, ordinary and extraordinary, of every kind and nature whatsoever, which may be levied, imposed, or assessed against the Leased Premises, or upon any improvements thereon, at any time after the Occupancy Date of this Lease for the period prior to the expiration of the term hereof, or any Renewal Term, if exercised.

  • Phase I a. In Phase I, the project will be connected as a tap to the Transmission Owner’s 230kV transmission line MWP-2 via one 230kV circuit breaker in series with one of two ring bus breakers for stuck breaker protection (one in each direction) and a tie-line breaker, as shown on the one-line diagram labeled CL-E-IA-01 attached to this Appendix A as Figure 1. The changes to the existing MWP-2 line protection for this arrangement are described in Phase I System Upgrades in Section II of this Appendix A.

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