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

  • 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.

  • 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. 4.2 The Authority reserves the right (acting reasonably) to specify that the MI Report be submitted by the Supplier using an alternative communication to that specified in paragraph 4.1 above such as email. The Supplier agrees to comply with any such instructions provided they do not materially increase the burden on the Supplier.

  • 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.

  • 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) 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 ▇▇▇▇▇▇▇▇ 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.