Measures to Minimize Bias Sample Clauses

Measures to Minimize Bias. Randomization and Blinding Single-blind (Run-in only) and double-blind (Treatment Period) techniques will be used. Vibegron and its matched placebo will be packaged identically so that the treatment blind is maintained. The subject, Investigator, and Sponsor personnel or delegate(s) who are involved in the treatment or clinical evaluation of the subjects will be unaware of the treatment group assignments during the double-blind Treatment Period. Subjects will be centrally assigned to randomized study drug using an interactive web response system (IWRS) and the randomization schedule generated by the Sponsor or designee. Before the screening is initiated at each site, login information and directions for the IWRS will be provided. The IWRS will be programmed with blind-breaking instructions. In case of an emergency, the Investigator has the sole responsibility for determining if unblinding of a subject’s study drug assignment is warranted. Subject safety must always be the first consideration in making such a determination. If the Investigator decides that unblinding is warranted, the Investigator should make every effort to contact the Sponsor or designee prior to unblinding a subject’s study drug assignment unless this could delay emergency treatment of the subject. If a subject’s study drug assignment is unblinded, the Sponsor or designee must be notified within 24 hours after breaking the blind. The date and reason that the blind was broken must be recorded in the source documentation. At the end of the study, the official, final database will be frozen and unblinded after medical/scientific review has been performed, and data have been declared final and complete. The Sponsor will be granted access to the unblinded database in order to analyze the data. A clinical study report will be prepared after all subjects complete the study.‌‌‌
Sample 1
AutoNDA by SimpleDocs
Measures to Minimize Bias. Randomization and Blinding
Sample 1
Measures to Minimize Bias. RANDOMIZATION AND MASKING This Phase I study will not include randomization or masking.
Sample 1

Related to Measures to Minimize Bias

  • Mitigating Factors The Contractor had a Trafficking in Persons compliance plan or an awareness program at the time of the violation, was in compliance with the plan, and has taken appropriate remedial actions for the violation, that may include reparation to victims for such violations.

  • Aggravating and Mitigating Factors The penalties in this matter were determined in consideration of all relevant circumstances, including statutory factors as described in CARB’s Enforcement Policy. CARB considered whether the violator came into compliance quickly and cooperated with the investigation; the extent of harm to public health, safety and welfare; nature and persistence of the violation, including the magnitude of the excess emissions; compliance history; preventative efforts taken; innovative nature and the magnitude of the effort required to comply, and the accuracy, reproducibility, and repeatability of the available test methods; efforts to attain, or provide for, compliance prior to violation; action taken to mitigate the violation; financial burden to the violator; and voluntary disclosure. The penalties are set at levels sufficient to deter violations, to remove any economic benefit or unfair advantage from noncompliance, to obtain swift compliance, and the potential costs, risks, and uncertainty associated with litigation. Penalties in future cases might be smaller or larger depending on the unique circumstances of the case.

  • Uncontrollable Forces Tariff Provisions Section 14.1 of the CAISO Tariff shall be incorporated by reference into this Agreement except that all references in Section 14.1 of the CAISO Tariff to Market Participants shall be read as a reference to the Participating Generator and references to the CAISO Tariff shall be read as references to this Agreement.

  • Sustainability 49.1 The Contractor shall perform its obligations under the Call-off Contract in a manner so as to:

  • Determination of Responsiveness 28.1 The Procuring Entity's determination of a Tender's responsiveness is to be based on the contents of the Tender itself, as defined in ITT28.2.

  • Non-Grievability No dispute over a claim for any benefits extended by this Health and Welfare Fund shall be subject to the grievance procedure.

  • ECONOMIC PRICE ADJUSTMENT is the adjustment to the Aircraft Basic Price (Base Airframe, Engine and Special Features) as calculated pursuant to Exhibit D.

  • Duration of processing and erasure or return of data Processing by the data importer shall only take place for the duration specified in Annex I.B. After the end of the provision of the processing services, the data importer shall, at the choice of the data exporter, delete all personal data processed on behalf of the controller and certify to the data exporter that it has done so, or return to the data exporter all personal data processed on its behalf and delete existing copies. Until the data is deleted or returned, the data importer shall continue to ensure compliance with these Clauses. In case of local laws applicable to the data importer that prohibit return or deletion of the personal data, the data importer warrants that it will continue to ensure compliance with these Clauses and will only process it to the extent and for as long as required under that local law. This is without prejudice to Clause 14, in particular the requirement for the data importer under Clause 14(e) to notify the data exporter throughout the duration of the contract if it has reason to believe that it is or has become subject to laws or practices not in line with the requirements under Clause 14(a).

  • ADJUSTMENT OF GRIEVANCES 26.01 Any complaint, disagreement or difference of opinion between the Employer and the Union, or the employees covered by this Agreement, which concerns the interpretation, application, operation or alleged violation of the terms and provisions of this Agreement, shall be considered as a grievance.

  • Failure to Maintain Financial Viability The System Agency may terminate the Contract if, in its sole discretion, the System Agency has a good faith belief that Grantee no longer maintains the financial viability required to complete the services and Deliverables, or otherwise fully perform its responsibilities under the Contract.

Time is Money Join Law Insider Premium to draft better contracts faster.