IN-VITRO PHASE Sample Clauses

IN-VITRO PHASE. Since this phase was conducted using data from the local EHR and without contacting clinicians or patients, it was termed “in-vitro”. This phase had two manifold aims: (i) to address implementation barriers according to the Consolidated Framework for Implementation Research (CFIR)38 (Figure 3-2), and (ii) to integrate the transdiagnostic risk calculator into the local EHR. Figure 3-1 Overview of in-vitro and in-vivo phases Figure 3-2 CFIR Implementation barriers addressed during the in-vitro phase. The CFIR frameworks identifies five core implementation domains: characteristics of the intervention (the ‘core components’—that is, the essential elements of the intervention— and the ‘adaptable periphery’—that is, the adaptable elements in which the intervention occurs); outer setting (the ‘economic, political, and social context within which an organisation resides’); inner setting (the ‘structural, political, and cultural context through which the intervention proceeds’ and the relationship between these elements); individuals (the individuals responsible for carrying out the intervention or otherwise related to the intervention, their agency, and their relationships to each other and the intervention) and process (the active process through which the desired changes are achieved).38 Crucially, several aspects were carefully planned at the stage of model development to facilitate its subsequent implementation. The “core components” of the CFIR characteristics of the transdiagnostic risk calculator (i.e. lifespan-inclusive, individualised, clinically-based, transdiagnostic, automatic data acquisition and risk estimation, cheap, use of predictors widely available in clinical routine, usability in a sequential assessment framework) 39 were selected a priori to match the CFIR “inner” and “outer” settings (Figure 3-2). The “adaptable periphery” of the CFIR characteristics of the intervention (Figure 3-2), required to adapt the transdiagnostic risk calculator (developed using retrospective data) to prospective use, after checking for data quality and missingness (which may differ in real-world prospective vs retrospective EHR datasets). In the retrospective version of the risk calculator, individuals who developed psychosis within three months following their index diagnosis were excluded to mitigate for ICD-10 diagnostic instability. However, prospective implementation of this diagnostic lag was inefficient. Subsequent analyses confirmed that a refined version of...
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Related to IN-VITRO PHASE

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Production Phase contract period in which the Development and the Production are to be performed.

  • Design Development Phase INDICATE IN STATEMENT OF WORK “NOT APPLICABLE” IF SECTION IS NOT APPLICABLE

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • PHASE is a distinct portion of the Work to be provided under this Agreement, as specified in the Statement Of Work.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

  • Design Development Phase Services 3.3.1 Based on the Owner’s approval of the Schematic Design Documents, and on the Owner’s authorization of any adjustments in the Project requirements and the budget for the Cost of the Work, the Architect shall prepare Design Development Documents for the Owner’s approval. The Design Development Documents shall illustrate and describe the development of the approved Schematic Design Documents and shall consist of drawings and other documents including plans, sections, elevations, typical construction details, and diagrammatic layouts of building systems to fix and describe the size and character of the Project as to architectural, structural, mechanical and electrical systems, and other appropriate elements. The Design Development Documents shall also include outline specifications that identify major materials and systems and establish, in general, their quality levels.

  • PRE-COMMENCEMENT PHASE Part 1 - Pre-commencement Phase Services Part 2 - Construction Documents and Site Plan SECTION 3 – CONSTRUCTION PHASE Part 1 - Construction Phase Services Part 2 - Changes to the Work Part 3 - Time. Part 4 - Correcting the Work, Inspections, Covering and Uncovering Work Part 5 - Subcontractors, Trade Contractors, and Suppliers

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