Validation Studies Sample Clauses

A Validation Studies clause outlines the requirements and procedures for conducting studies to confirm the accuracy, reliability, or effectiveness of a product, process, or system. Typically, it specifies the standards to be met, the methodology to be used, and the responsibilities of each party in carrying out the validation. For example, it may require a manufacturer to perform clinical or technical tests before a product is released or accepted. The core function of this clause is to ensure that all parties have confidence in the performance and compliance of the subject under review, thereby reducing the risk of defects or failures after implementation.
Validation Studies. Centogene shall perform, where required under Applicable Laws, and provide Shire with updated validation studies and stability studies on a yearly basis at its own costs.
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Validation Studies. The design and interpretation of comparative inter- laboratory studies to establish the reliability and relevance of the EDSP optimized transferable protocols. Following validation, the optimized transferable protocols will provide the basis for endocrine disruptor test guidelines for regulatory use.
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Validation Studies. The County may periodically conduct formal validation studies of HMIS Data (the "Validation Studies"). GSS will ensure the validity of the information entered into HMIS and will provide access to the County for review, as needed, to verify the accuracy of the data reported in the HMIS database. The Subrecipient will not be involved in this process as they do not have access to HMIS data.
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Validation Studies. (a) CCC shall perform the following validation studies to further validate the processes and methodology used in its valuation product and services: (1) Condition Usage/Wear Standards Study The primary objective of this study is to further validate and update at the component level the set of defining vehicle condition characteristics. This study will include nationwide field research in urban and rural areas to ascertain the condition characteristics present on vehicles located in dealer lots and on the street. This research will provide coverage across six vehicle types and all vehicle model age groups. The determination of the composition of the model age groups will also be addressed by this study. (2) Vehicle Condition Market Value Impact Study The primary objective of this study, which will be performed through the use of the findings of the study identified in Item No. 1, is to further validate the impact of a vehicle’s condition on its market value. This study will test for dependencies vis-à-vis condition across multiple variables (i.e., vehicle type, age group, price range, and market). (3) Refurbished, Rebuilt, and Restored Components Value Impact Study The primary objective of this study is to further validate the market value impact of refurbished, rebuilt, and restored components on a vehicle. This study will assess the positive and/or negative impact (if any) the presence of refurbished, rebuilt, and/or restored components has on a vehicle. This study will entail, inter alia, the comparison of comparable vehicles with and without refurbished, rebuilt, and/or restored components (e.g., a 1995 Taurus LX with and without a refurbished engine). This study will also address the difference in impact (if any) as between refurbished, rebuilt, and restored components.
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Validation Studies a. The System Administrator may periodically conduct formal validation studies of the Data (“Validation Studies”). In order to conduct the Validation Studies, auditor(s) selected by the System Administrator may review Agency's records for purposes of verifying the validity of the information included in the Ohio BoSCoC HMIS database. Individuals involved in conducting any such Validation Studies shall sign a confidentiality agreement requiring them to maintain the confidentiality of the Data and the Agency records reviewed. b. Agency hereby authorizes the auditor(s) to review Agency's records for purposes of verifying the validity of the information included in the Ohio BoSCoC HMIS. Agency also hereby authorizes the System Administrator to use the results of the Validation Studies, including for purposes of making future resource allocation decisions.
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Validation Studies. There have been three validation studies on MVBT so far. The first study by ▇▇▇▇▇ et al. (2023) compared MVBT (version 0.5.4) with 3D motion capture during the bench press, back squat and deadlift on two separate testing days. For all exercises, 40kg was used for two working sets of eight repetitions, at fast and slow velocities. Slow sets were performed with a two second eccentric and a two second concentric. Fast sets were performed by controlling the eccentric and then moving as fast as possible during the concentric. Agreement between the devices regarding MCV and ROM was assessed using ▇▇▇▇▇▇▇’▇ zero-order product-moment correlation and ▇▇▇▇▇-▇▇▇▇▇▇ plots. In the study of ▇▇▇▇▇ and colleagues, ▇▇▇▇▇▇▇’▇ r showed moderate to nearly perfect correlations for all exercises and metrics. Correlation between MVBT and the criterion device was highest for fast squats for MCV (r = 0.95) and slow squats for ROM (r = 0.94). The lowest correlations were seen in the slow bench press for both MCV (r = 0.67) and ROM (r = 0.43). MCV biases for all exercises were <0.06 m/s, and below 2 cm for ROM. However, ▇▇▇▇▇-▇▇▇▇▇▇ plots showed large limits of agreement (LoA) for both MCV and ROM on all exercises. The lowest agreement was found for the fast deadlift, where upper and lower LoA were 0.39 and -0.43 m/s. Agreement was highest for the fast squat, with 0.16 and -0.16 m/s upper and lower LoA. The authors speculated that ROM was especially affected by differences in motion tracking algorithms between devices. Slow movements where velocities are close to zero may have led to false calculations. Overall, the study by ▇▇▇▇▇ et al. (2023) is limited by the use of fixed exercise weight of 40kg for all exercises. Furthermore, prescribing artificially slow movement velocities may lead to unnatural movement patterns. Ecological validity might be compromised, since only a small portion of the loading spectrum has been covered and participants did not approximate failure during any exercise. Additionally, only linear exercises were used, and findings may differ for more complex exercises like Olympic lifts or horizontal patterns like rows. The study only looked at MCV and ROM, while PCV was not compared between devices. Even though the authors concluded that MVBT is a valid measurement tool based on moderate to nearly perfect correlation coefficients, large limits of agreement for all exercises and metrics disagree with the statement that MVBT can be used instead of a criterion devi...
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Validation Studies. The County may periodically conduct formal validation studies of HMIS Data (the "Validation Studies"). In order to conduct the Validation Studies, staff selected by the County may review the Subrecipient's records for purposes of verifying the validity of the information reported to the County and included in the HMIS database. Individuals involved in the conducting of any such Validation Studies shall sign a confidentiality agreement requiring them to maintain the confidentiality of the Data pertaining to a particular Subrecipient client. The Subrecipient hereby authorizes the County to review the Subrecipient's records for purposes of verifying the validity of the information reported to the County.
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Validation Studies. The objective is to share information and develop consensus when feasible on critical aspects, prior to the conduct of validation studies, regarding: • Study objectives • Specific regulatory testing purpose • Proposed validation study design • Detailed study protocols • Substances to be tested • The basis for the selection of test substances • Participating laboratories
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Validation Studies. (a) CCC shall perform the following validation studies to further validate the processes and methodology used in its valuation product and services: (1) Condition Usage/Wear Standards Study The primary objective of this study is to further validate and update at the component level the set of defining vehicle condition characteristics. This study will include nationwide field research in urban and rural areas to ascertain the condition characteristics present on vehicles located in dealer lots and on the street. This research will provide coverage across six vehicle types and all vehicle model age groups. The determination of the composition of the model age groups will also be addressed by this study.
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Related to Validation Studies

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • 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 or the Prospectus, or the results of which are referred to in the Registration Statement 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 EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement 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 Registration Statement or 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 or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, 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 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.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in ▇▇▇▇ rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.