Provádění klinického hodnocení Clinical Trial Performance Sample Clauses

Provádění klinického hodnocení Clinical Trial Performance. 1.1 Poskytovatel a hlavní zkoušející poskytnou určité služby (dále jen „služby”) spojené s prováděním klinického hodnocení v souladu s protokolem (a jeho případnými změnami a doplňky provedenými v souladu s touto smlouvou), a dále s veškerými platnými zákony, pravidly a předpisy vztahujícími se na klinické hodnocení. Protokol musí být nejprve schválen příslušným regulačním orgánem, multicentrickou etickou komisí a/nebo místní etickou komisí (souhrnně označovány jako „RA/EC”). Schválení RA/EC tvoří Přílohu 7 této smlouvy. RA/EC musí schválit také informovaný souhlas (dále jen „informovaný souhlas”). V případě nesrovnalostí nebo rozporu mezi podmínkami uvedenými v protokolu a v této smlouvě mají ustanovení protokolu přednost v záležitostech klinických, a ustanovení smlouvy mají přednost ve všech ostatních záležitostech. 1.1 Institution and Principal Investigator shall provide certain services (“Services”) related to the conduct of the Clinical Trial, in accordance with the Protocol, (and any subsequent amendments made thereto in accordance with this Agreement, and with all applicable laws, rules and regulations relating to the Clinical Trial. The Protocol is subject to approval by the appropriate Regulatory Authority, Multi-center Ethics Committee, and/or Local Ethics Committee (collectively “RA/EC”) The RA/EC approvals are attached to this Agreement as Schedule 7. The informed consent (“Informed Consent”) is subject to approval by the RA/EC. If there is any discrepancy or conflict between the terms contained in the Protocol and this Agreement, the terms of the Protocol shall govern and control with respect to clinical matters and the terms of the Agreement shall govern and control with respect to all other matters.
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Related to Provádění klinického hodnocení Clinical Trial Performance

  • 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.

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

  • STATEWIDE ACHIEVEMENT TESTING When CONTRACTOR is an NPS, per implementation of Senate Bill 484, CONTRACTOR shall administer all Statewide assessments within the California Assessment of Student Performance and Progress (“CAASP”), Desired Results Developmental Profile (“DRDP”), California Alternative Assessment (“CAA”), achievement and abilities tests (using LEA-authorized assessment instruments), the Fitness Gram with the exception of the English Language Proficiency Assessments for California (“ELPAC”) to be completed by the LEA, and as appropriate to the student, and mandated by XXX xxxxxxxx to LEA and state and federal guidelines. CONTRACTOR is subject to the alternative accountability system developed pursuant to Education Code section 52052, in the same manner as public schools. Each LEA student placed with CONTRACTOR by the LEA shall be tested by qualified staff of CONTRACTOR in accordance with that accountability program. XXX shall provide test administration training to CONTRACTOR’S qualified staff. CONTRACTOR shall attend LEA test training and comply with completion of all coding requirements as required by XXX.

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  • 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.

  • 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).

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  • Synchronisation Commissioning and Commercial Operation 8.1 The Developer shall provide at least forty (40) days advanced preliminary written notice and at least twenty (20) days advanced final written notice to ESCOM of the date on which it intends to synchronize the Power Project to the Grid System.

  • Trials The Ship shall run the following test and trials:

  • Synchronization, Commissioning and Commercial Operation 4.1.1 The Power Producer shall give at least thirty (30) days written notice to the SLDC and GUVNL, of the date on which it intends to synchronize the Power Project to the Grid System.

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