Blinded Sample Size Re-Calculation Sample Clauses

Blinded Sample Size Re-Calculation. A sample size re-calculation will be performed to evaluate on a blinded basis the study assumptions used to calculate sample size. A sample size re-calculation committee (SRC), comprised of Sponsor personnel and the study’s blinded statistician, will be established to re- calculate sample size based on blinded assessment of study assumptions. The SRC will review available data (e.g., baseline characteristics, study drug discontinuations, variability in 6MWD change from baseline, intra-patient autocorrelations of 6MWD) when approximately 100 patients have been enrolled in the study. The Sponsor may increase the sample size of the study up to approximately 200 patients. An increase of sample size within this range will be documented in a note-to-file to the investigators/IRBs/ECs (as appropriate) and will not require a protocol amendment. Because these analyses will be based on pooled, blinded data they will not impact the Type I error rate. An appendix to the Statistical Analysis Plan (SAP) will present details regarding the planned re-calculation of sample size.
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Related to Blinded Sample Size Re-Calculation

  • Completion of Evaluation Cycle 1. The summative evaluation rating shall be based upon a preponderance of the evidence, assessed in a holistic manner, that is aligned to the Ohio Educator Standards. Only evidence gathered during the walkthroughs and formal observations that are conducted for the current school year may be used.

  • For Lump Sum Change Order The payment and extension of time (if any) provided by this Change Order constitutes compensation in full to the Contractor and its Subcontractors and Suppliers for all costs and markups directly and indirectly attributable to the Change Order herein, for all delays related thereto and for performance of changes within the time stated.

  • Selection Under a Fixed Budget Services for assignments which the Association agrees meet the requirements of paragraph 3.5 of the Consultant Guidelines may be procured under contracts awarded on the basis of a Fixed Budget in accordance with the provisions of paragraphs 3.1 and 3.5 of the Consultant Guidelines.

  • Offense Level Calculations i. The base offense level is 7, pursuant to Guideline § 2B1.1(a)(1).

  • PRICE ESCALATION/DE-ESCALATION (CPI) The County may allow a price escalation provision within this award. The original contract prices shall be firm for an initial one (1) year period. A price escalation/de-escalation will be considered at one (1) year intervals thereafter, provided the Contractor notifies the County, in writing, of the pending price escalation/de-escalation a minimum of sixty (60) days prior to the effective date. Price adjustments shall be based on the latest version of the Consumers Price Index (CPI-U) for All Urban Consumers, All Items, U.S. City Average, non-seasonal, as published by the U.S. Department of Labor, Bureau of Labor Statistics. This information is available at xxx.xxx.xxx. Price adjustment shall be calculated by applying the simple percentage model to the CPI data. This method is defined as subtracting the base period index value (at the time of initial award) from the index value at time of calculation (latest version of the CPI published as of the date of request for price adjustment), divided by the base period index value to identify percentage of change, then multiplying the percentage of change by 100 to identify the percentage change. Formula is as follows: Current Index – Base Index / Base Index = % of Change % of Change x 100 = Percentage Change CPI-U Calculation Example: CPI for current period 232.945 Less CPI for base period 229.815 Equals index point change 3.130 Divided by base period CPI 229.815 Equals 0.0136 Result multiplied by 100 0.0136 x 100 Equals percent change 1.4% A price increase may be requested only at each time interval specified above, using the methodology outlined in this section. To request a price increase, Contractor shall submit a letter stating the percentage amount of the requested increase and adjusted price to the Orange County Procurement Division. The letter shall include the complete calculation utilizing the formula above, and a copy of the CPI-U index table used in the calculation. The maximum allowable increase shall not exceed 4%, unless authorized by the Manager, Procurement Division. All price adjustments must be accepted by the Manager, Procurement Division and shall be memorialized by written amendment to this contract. No retroactive contract price adjustments will be allowed. Should the CPI-U for All Urban Consumers, All Items, U.S City Average, as published by the U.S. Department of Labor, Bureau of Labor Statistics decrease during the term of the contract, or any renewals, the Contractor shall notify the Orange County Procurement Division of price decreases in the method outlined above. If approved, the price adjustment shall become effective on the contract renewal date. If the Contractor fails to pass the decrease on to the County, the County reserves the right to place the Contractor in default, cancel the award, and remove the Contractor from the County Vendor List for a period of time deemed suitable by the County. In the event of this occurrence, the County further reserves the right to utilize any options as stated herein.

  • SUBMISSION OF THE MONTHLY MI REPORT 4.1 The completed MI Report shall be completed electronically and returned to the Authority by uploading the electronic MI Report computer file to MISO in accordance with the instructions provided in MISO.

  • 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.

  • Rental Rates and Wage Rates for Change Orders As soon as is practical, but prior to the completion of the Construction Preparation Period and in any event prior to the commencement of any Work on the Site, the Contractor shall submit in accordance with the style and format of a specimen to be furnished by the Owner for consideration of the Owner the following: (1) a proposal for rental rates on heavy construction equipment that shall apply in the event Change Order Work is performed, and (2) a proposal for wage rates for the types of project labor that shall apply in the event of the execution of any Change Order Work. Under penalty of false swearing, a principal of the contracting firm shall certify that the proposal for rental rates and proposal for wage rates do not exceed current costs for like services. The Owner will in no event consider a rental rate in excess of eighty percent of the rate set forth in the latest edition of the "Compilation of Nationally Averaged Rental Rates for Construction Equipment" of the Associated Equipment Distributors unless the rates proposed in excess of eighty percent are supported by proof satisfactory to the Owner that the excess rates are reasonable. If the equipment is owned by the Contractor the costs shall be charged at a maximum of eighty percent of market monthly rental rates for the amount of time used. If applicable, transportation costs may be included. The decision of the Owner shall be final, binding and conclusive on all parties. Rental rates shall be payable only for the actual time the equipment is required on the Site.

  • Average Log Length and Payment Reduction If the average log length for all logs delivered under this contract is less than the average log length specified in the table in clause G-024.2, The amount of allowable payment reduction shall be calculated by multiplying the payment rate in P-028.2 by the total volume delivered, and the difference between the average length of logs delivered and the average log length specified in G-024.2, times 1% as follows: Log Length Payment Reduction = (B x V x L) x (.01) 1/10th) Where: B = Bid rate from P-028.2 clause V = total delivered log Volume L = Length in feet below specified average (rounded to nearest Average log length payment reductions calculated by the Purchaser must be approved by the State, prior to payment for the final billing period. Third-party scaling organization information is required to determine Xxxxxxxx mbf and Average log length for payment reduction purposes. Average log length is determined on a piece count basis. Value of log length price reduction will be derived from the applicable sort value as described in this contract. Scale information for determining Average log length for payment reduction eligibility must be obtained from roll-out scale. Truck-ramp, sample scaling, and/or bundle scaling information is not acceptable for determining eligibility. Purchaser’s exclusive remedy for below average log lengths shall be the payment reduction described in this clause, notwithstanding other provisions in the Uniform Commercial Code.

  • Single Audit Subrecipient must be audited as required by 2 CFR part 200, subpart F when it is expected that Subrecipient's Federal awards expended during the respective fiscal year equaled or exceeded the threshold set forth in §200.501 Audit requirements.

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