Conduct of interim analyses Sample Clauses

Conduct of interim analyses. Interim analyses, unblinded to treatment allocation, will be undertaken by a Safety and Efficacy Data Monitoring Committee (SEDMC). This committee will be formed specifically to oversee trial progression with regards serious adverse event (SAE) occurrence and to carry out the planned interim efficacy analyses. The committee, which will comprise a minimum of 3 people, will include an independent statistician and an independent respiratory clinician with experience in COPD. Analyses planned or requested by the SEDMC will be carried out by the independent statistician and transmitted to the SEDMC directly. All interim evaluations (safety and efficacy) will be disclosed only within the SEDMC. In addition to the planned efficacy interim analysis, tables of SAEs will be prepared by the independent statistician and these will be provided to the SEDMC at regular intervals. Safety updates will be prepared so as to be available for review at the same time as the efficacy data are being reviewed (i.e., at each of the two planned interim analyses). Following completion of each interim analysis, the SEDMC will give a recommendation to the Steering Committee as to whether the trial should be stopped prematurely following review of the interim results for safety and efficacy. The Steering Committee will, in conjunction with the Sponsor, decide whether to act on this recommendation. In addition to monitoring safety and efficacy, the SEDMC will also assess whether the planned overall study size is adequate in light of the observed numbers of deaths. If necessary, the SEDMC may recommend increasing the overall trial size, or extending the period of follow-up, in order to ensure adequate power for the trial to give a definitive result. Such recommendations, if necessary, will be made to the Steering Committee. Membership, functions and operating procedures of the Steering Committee, SEDMC and other organisational groups for this study will be defined in a separate document. Operating procedures for the SEDMC will be established before the first interim analysis.
Sample 1
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Related to Conduct of interim analyses

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  • Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

  • Geotechnical Engineer « »« » « » « » « » « »

  • Feasibility Study Buyer will, at Buyer's expense and within ____ days from Effective Date ("Feasibility Study Period"), determine whether the Property is suitable, in Buyer's sole and absolute discretion, for ___________________ use. During the Feasibility Study Period, Buyer may conduct a Phase I environmental assessment and any other tests, analyses, surveys and investigations ("Inspections") that Buyer deems necessary to determine to Buyer's satisfaction the Property's engineering, architectural and environmental properties; zoning and zoning restrictions; subdivision statutes; soil and grade; availability of access public roads, water, and other utilities; consistency with local, state and regional growth management plans, availability of permits, government approvals, and licenses; and other inspections that Buyer deems appropriate to determine the Property's suitability for the Buyer's intended use. If the Property must be rezoned, Buyer will obtain the rezoning from the appropriatx xxxernment agencies. Seller will sign all documents Buyer is required to file in connection with development or rezoning approvals. Seller gives Buyer, its agents, contractors and assigns, the right to enter the Property at any time during the Feasibility Study Period for the purpose of conducting inspections; provided, however, that Buyer, its agents, contractors and assigns enter the Property and conduct inspections at their own risk. Buyer will indemnify and hold Seller harmless from xxxxes, damages, costs, claims and expenses of any nature, including attorney's fees, expenses and liability incurred in application for rezoning or related proceedings, and from liability to any person, arising from the conduct of any and all inspections of any work authorized by Buyer. Buyer will not engage in any activity that xxxxx result in a construction lien being filed against the Property without Seller's prior written consent. If this transaction does not close, Buyer will, at Buyer's expense, (1) repair all damages to the Property resulting from the Inspections and return the Property to the condition it was in prior to conduct of the Inspections, and (2) release to Seller all reports and other work generated as a result of the Inspections. Buyer will deliver written notice to Seller prior to the expiration of the Feasibility Study Period of Buyer's determination of whether or not the Properxx xx acceptable. Buyer's failure to comply with this notice requirement will constitute acceptance of the Property as suitable for Buyer's intended use in its "as is" condition. If the Property is unacceptable to Buyer and written notice of this fact is timely delivered to Seller, this Contract will be deemed terminated as of the day after the Feasibility Study period ends and Buyer's deposit(s) will be returned after Escrow Axxxx receives proper authorization form all interested parties.

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