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Risk-Benefit-Assessment Sample Clauses

Risk-Benefit-Assessment. Many pediatric surgical centers worldwide routinely perform MFR after enterostomy creation. However, due to a lack of prospective studies the level of evidence showing a benefit of this treatment strategy is low. Although the systematic review by Xxxxxxxxxx et al. [4] showed no complications using this technique, MFR into the distal bowel loop may potentially cause complications such as bowel perforation. The risk for possible complications can be minimized by careful and standardized manipulation of the enterostomies. The local condition of the ostomy will be investigated twice daily. If our hypothesis is confirmed, the postoperative hospital care of infants undergoing ostomy closure will be shortened. The benefits of MFR may include a shorter duration and therefore less side effects of parenteral nutrition. Moreover, an economic benefit through lower costs for TPN and a shorter hospital stay may be reached. The results of the current study may influence the standard of neonatal intensive care. Therefore the potential benefits of MFR outweigh the possible risks of this study. Results of data analyses including all data how to perform MFR will be published. If the results of this study will show significant differences between the intervention group and controls, MFR will become the new standard of care for neonates with enterostomies. In Germany, the current national guideline for neonatal and surgical treatment of necrotizing enterocolitis (NEC) is currently in revision [Leitlinie 024-009: Nekrotisierende Enterokolitis (NEK)]. One of the principal investigators of the study (Prof. Xx. Xxxxxx Xxxxxx) is coauthor of this guideline. If the current study proves the hypothesis that MFR is beneficial for these infants it may not only change the national guideline for the best treatment after enterostomy creation in Germany but in other countries too.
Risk-Benefit-AssessmentBased on the formal risk assessment, the TFNT00 IOL demonstrates a risk profile that is comparable to the FDA-approved ACRYSOF IQ ReSTOR +3.0 Add Power IOL (Model SN6AD1) . Furthermore, it was concluded that the benefits of increased intermediate vision while maintaining visual performance at near distance significantly outweigh the risks of suboptimal surgical outcomes and when the TFNT00 IOL is used in cataract surgery. Potential risks following implantation of both the TFNT00 IOL and the 839MP IOL (Law 2014) include visual disturbances such as glare and halos which are known risks for multifocal IOLs. The benefits of improved near and intermediate vision, when weighed against the risks of visual disturbances, result in a benefit to risk profile that is favorable for the both the test and control IOLs (Law 2014).
Risk-Benefit-Assessment. The [***] in this [***] are [***].
Risk-Benefit-Assessment. ‌ The Italian study of oral glutathione in CF children did not report any significant adverse events (AE) associated with GSH administration [6]. Hypothetical concerns regarding alteration of levels of GSH, including alterations of immune modulation have been expressed [28], however are unlikely to be apparent in this short term study. Notably, oral glutathione is readily available as a nutritional supplement. The reported risks associated with these supplements are those associated with taking high concentrations of vitamins, primarily gastrointestinal distress. Additionally, there have been rare anecdotal reports of transitory increase of flatulence and hypersensitivity reactions including skin rashes. Glutathione has generally been shown to be poorly absorbed from the GI tract in humans, thus we anticipate that any adverse events related to the study drug are likely to be GI in nature. The planned study will systematically collect information about gastrointestinal symptoms and includes regular monitoring of subjects through study visits and phone calls. The risks associated with the study procedures (blood draws, fecal specimen collection, and spirometry) are minimal. The data from the earlier study of oral glutathione in children with CF showing improved growth and reduced intestinal inflammation is promising, and the safety profile observed to date suggests an appropriate risk/benefit balance for the proposed study.

Related to Risk-Benefit-Assessment

  • Performance Assessment 6.1 The Performance Plan (Annexure A) to this Agreement sets out key performance indicators and competencies that needs to be evaluated in terms of – 6.1.1 The standards and procedures for evaluating the Employee’s performance; and 6.1.2 During the intervals for the evaluation of the Employee’s performance. 6.2 Despite the establishment of agreed intervals for evaluation, the Employer may in addition review the Employee’s performance at any stage while the contract of employment remains in force; 6.3 Personal growth and development needs identified during any performance review discussion must be documented in a Personal Development Plan as well as the actions agreed to and implementation must take place within set time frames; 6.4 The Employee’s performance will also be measured in terms of contributions to the goals and strategies set out in the Employer’s Integrated Development Plan (IDP) as described in 6.6 – 6.13 below; 6.5 The Employee will submit quarterly performance reports (SDBIP) and a comprehensive annual performance report at least one week prior to the performance assessment meetings to the Evaluation Panel Chairperson for distribution to the panel members for preparation purposes; 6.6 Assessment of the achievement of results as outlined in the performance plan: 6.6.1 Each KPI or group of KPIs shall be assessed according to the extent to which the specified standards or performance targets have been met (qualitative and quantitative) and with due regard to ad-hoc tasks that had to be performed under the KPI; 6.6.2 A rating on the five-point scale described in 6.9 below shall be provided for each KPI or group of KPIs which will then be multiplied by the weighting to calculate the final score; 6.6.3 The Employee will submit his self-evaluation to the Employer prior to the formal assessment; 6.6.4 In the instance where the employee could not perform due to reasons outside the control of the employer and employee, the KPI will not be considered during the evaluation. The employee should provide sufficient evidence in such instances; and 6.6.5 An overall score will be calculated based on the total of the individual scores calculated above.

  • Risk Assessment An assessment of any risks inherent in the work requirements and actions to mitigate these risks.

  • Joint Assessment If the Premises are not separately assessed, Lessee's liability shall be an equitable proportion of the Real Property Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be conclusively determined by Lessor from the respective valuations assigned in the assessor's work sheets or such other information as may be reasonably available.

  • Risk Assessments a. Risk Assessment - DST shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats Schedule 10.2 p.2 occurring and the impact of those threats upon DST organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”). b. Risk Mitigation - DST shall use commercially reasonable efforts to manage, control and remediate threats identified in the Risk Assessments that it believes are likely to result in material unauthorized access, copying, use, processing, disclosure, alteration, transfer, loss or destruction of Fund Data, consistent with the Objective, and commensurate with the sensitivity of the Fund Data and the complexity and scope of the activities of DST pursuant to the Agreement. c. Security Controls Testing - DST shall, on approximately an annual basis, engage an independent external party to conduct a review (including information security) of DST’s systems that are related to the provision of services. DST shall have a process to review and evaluate high risk findings resulting from this testing.

  • Data Protection Impact Assessment If, pursuant to Data Protection Law, Customer (or its Controllers) are required to perform a data protection impact assessment or prior consultation with a regulator, at Customer’s request, SAP will provide such documents as are generally available for the Cloud Service (for example, this DPA, the Agreement, audit reports or certifications). Any additional assistance shall be mutually agreed between the Parties.

  • No Joint Assessment Borrower shall not suffer, permit or initiate the joint assessment of the Property (a) with any other real property constituting a tax lot separate from the Property, and (b) which constitutes real property with any portion of the Property which may be deemed to constitute personal property, or any other procedure whereby the lien of any taxes which may be levied against such personal property shall be assessed or levied or charged to such real property portion of the Property.

  • Conformity Assessment Procedures 1. Each Party shall give positive consideration to accepting the results of conformity assessment procedures of other Parties, even where those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures. 2. Each Party shall seek to enhance the acceptance of the results of conformity assessment procedures conducted in the territories of other Parties with a view to increasing efficiency, avoiding duplication and ensuring cost effectiveness of the conformity assessments. In this regard, each Party may choose, depending on the situation of the Party and the specific sectors involved, a broad range of approaches. These may include but are not limited to: (a) recognition by a Party of the results of conformity assessments performed in the territory of another Party; (b) recognition of co-operative arrangements between accreditation bodies in the territories of the Parties; (c) mutual recognition of conformity assessment procedures conducted by bodies located in the territory of each Party; (d) accreditation of conformity assessment bodies in the territory of another Party; (e) use of existing regional and international multilateral recognition agreements and arrangements; (f) designating conformity assessment bodies located in the territory of another Party to perform conformity assessment; and (g) suppliers’ declaration of conformity. 3. Each Party shall exchange information with other Parties on its experience in the development and application of the approaches in Paragraph 2(a) to (g) and other appropriate approaches with a view to facilitating the acceptance of the results of conformity assessment procedures. 4. A Party shall, upon request of another Party, explain its reasons for not accepting the results of any conformity assessment procedure performed in the territory of that other Party.

  • Public Benefit It is Reaction Retail’s understanding that the commitments it has agreed to herein, and actions to be taken by Reaction Retail under this Settlement Agreement, would confer a significant benefit to the general public, as set forth in Code of Civil Procedure § 1021.5 and Cal. Admin. Code tit. 11, § 3201. As such, it is the intent of Reaction Retail that to the extent any other private party initiates an action alleging a violation of Proposition 65 with respect to Reaction Retail’s failure to provide a warning concerning exposure to DEHP prior to use of the Products it has manufactured, distributed, sold, or offered for sale in California, or will manufacture, distribute, sell, or offer for sale in California, such private party action would not confer a significant benefit on the general public as to those Products addressed in this Settlement Agreement, provided that Reaction Retail is in material compliance with this Settlement Agreement.

  • Employee Plan Compliance (i) Q5 and Q5 Subsidiaries have performed in all material respects all obligations required to be performed by them under, are not in material default or violation of, and have no Knowledge of any default or violation by any other party to each Q5 Employee Plan, and each Q5 Employee Plan has been established and maintained in all material respects in accordance with its terms and in material compliance with all applicable laws, statutes, orders, rules and regulations, including but not limited to ERISA and the Code; (ii) each Q5 Employee Plan intended to qualify under Section 401(a) of the Code and each trust intended to qualify under Section 501(a) of the Code has either received a favorable determination, opinion, notification or advisory letter from the IRS with respect to each such Q5 Employee Plan as to its qualified status under the Code or has remaining a period of time under applicable Treasury regulations or IRS pronouncements in which to apply for such a letter and make any amendments necessary to obtain a favorable determination as to the qualified status of each such Q5 Employee Plan; (iii) no "prohibited transaction," within the meaning of Section 4975 of the Code or Sections 406 and 407 of ERISA, and not otherwise exempt under Section 4975 or Section 408 of ERISA (or any administrative class exemption issued thereunder), has occurred with respect to any Q5 Employee Plan; (iv) there are no actions, suits or claims pending, or, to the Knowledge of Q5 or any Q5 Subsidiary, threatened or reasonably anticipated (other than routine claims for benefits) against any Q5 Employee Plan or against the assets of any Q5 Employee Plan; (v) there are no audits, inquiries or proceedings pending or, to the Knowledge of Q5 or any of Q5 Subsidiaries, or any ERISA Affiliates, threatened by the IRS or DOL with respect to any Q5 Employee Plan; and (vi) neither Q5, Q5 Subsidiaries, nor any ERISA Affiliate is subject to any penalty or tax with respect to any Q5 Employee Plan under Section 502(i) of ERISA or Sections 4975 through 4980 of the Code.

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013). 6.3.2 Teachers shall use their professional judgment to determine which assessment and/or evaluation tool(s) from the Board list of preapproved assessment tools is applicable, for which student(s), as well as the frequency and timing of the tool. In order to inform their instruction, teachers must utilize diagnostic assessment during the school year.