Inspection by Competent Authority Sample Clauses

Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
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Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information. (d) Kontrola prováděná příslušným orgánem. Pokud si Příslušný orgán (národní nebo zahraniční) přeje provést kontrolu ve Zdravotnickém zařízení nebo ve vztahu ke Zkoušejícímu v souvislosti s jejich účastí v Klinickém hodnocení, jsou Zdravotnické zařízení, Zkoušející a Personál v důvodně požadovaném rozsahu povinni (i) okamžitě o tom vyrozumět společnost Biogen a vynaložit veškeré úsilí, aby zajistili, že společnost Biogen nebo její zástupci mohou být při kontrole přítomni, a (ii) poskytnout Příslušným orgánům součinnost a splnit oprávněné požadavky kontroly. To zahrnuje zpřístupnění (pro účely prostudování a okopírování) dokumentace, údajů a informací týkajících se Klinického hodnocení. V případech, kdy to bude nutné k ověření zdrojového dokumentu v rámci kontroly, budou dány k dispozici také zdravotní záznamy subjektu. Zdravotnické zařízení zajistí, že Zkoušející a další členové Personálu budou Příslušnému orgánu k dispozici pro účely vysvětlení a projednání takové dokumentace, údajů a informací.
Sample 1
Inspection by Competent Authority. The Institution and the Principal Investigator acknowledge that the Trial is (c) Spolupráce na auditu prováděném Hexalem. Zdravotnické zařízení bude spolupracovat a rovněž zajistí, že hlavní zkoušející a pracovníci podílející se na klinickém hodnocení budou spolupracovat s Hexalem a jeho dodavateli a zástupci v případě interních auditů, na základě odpovídajícího oznámení a v průběhu normální pracovní doby. Zdravotnické zařízení dále zpřístupní Hexalu a jeho dodavatelům a zástupcům (pro kontrolu a duplikaci) veškerou dokumentaci, data a informace týkající se klinického hodnocení. Zdravotní dokumentace subjektů bude podle potřeby zpřístupněna tam, kde je to nezbytné pro účely ověřování zdrojové dokumentace jako součásti auditu. Zdravotnické zařízení zajistí, aby hlavní zkoušející a pracovníci podílející se na klinickém hodnocení byli k dispozici Hexalu a jeho dodavatelům a zástupcům k případným konzultacím v souvislosti s dokumentací, daty a záznamy. Pro odstranění případných pochybností, součinnost při auditech bude poskytována hlavním
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent (d) Kontrola prováděná příslušným orgánem. Pokud si Příslušný orgán (národní nebo zahraniční) přeje provést kontrolu ve Zdravotnickém zařízení nebo ve vztahu ke Zkoušejícímu v souvislosti s jejich účastí v Klinickém hodnocení, jsou Zdravotnické
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen Idec thereof and use their best
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply přítomni, a (ii) poskytnout Příslušným orgánům součinnost a splnit oprávněné požadavky kontroly. To zahrnuje zpřístupnění (pro účely prostudování a okopírování) dokumentace, údajů a informací týkajících se Klinického hodnocení. V případech, kdy to bude nutné k ověření zdrojového dokumentu v rámci kontroly, budou dány k dispozici také zdravotní záznamy subjektu. Zdravotnické zařízení zajistí, že Zkoušející a další členové Personálu budou Příslušnému orgánu k dispozici pro účely vysvětlení a projednání takové dokumentace, údajů a informací. with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspectionin accordance with Act No. 372/2011 Coll., as amended. The Institution also shall znění. Zdravotnické zařízení zajistí, že Zkoušející a další členové Personálu budou Příslušnému orgánu k dispozici pro účely vysvětlení a projednání takové dokumentace, údajů a informací. make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
Sample 1
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Inspection by Competent Authority. If a Competent Authority wishes to inspect the InstitutionFoundation or the Investigator in connection with their participation in the Trial, then the InstitutionFoundation, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The (d) Inspección de la Autoridad competente. Si una Autoridad competente desea inspeccionar la InstituciónFundación o al Investigador en relación con su participación en el Ensayo, la InstituciónFundación, el Investigador y el Personal, en la medida en que sea razonablemente factible, (i) notificarán de inmediato a Biogen sobre ello y emplearán sus mejores esfuerzos para obtener la aprobación a fin de que Biogen o sus agentes estén presentes en la inspección y (ii) colaborarán con la Autoridad competente y cumplirán los requisitos legítimos de una inspección. Esto también incluye poner a disposición (para su examen y copia) la documentación, los datos y la información relacionada con el Ensayo. Los registros médicos de los Sujetos se pondrán a disposición cuando se los InstitutionFoundation also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information. solicite, con el fin de realizar la verificación de los documentos fuente como parte de la inspección. La InstituciónFundación también pondrá al Investigador y al Personal a disposición de la Autoridad competente relevante para explicar y analizar dicha documentación, datos e información.
Sample 1

Related to Inspection by Competent Authority

  • RIGHT OF INSPECTION AND REJECTION The City expressly reserves all rights under law, including, but not limited to the Uniform Commercial Code, to inspect the deliverables at delivery before accepting them, and to reject defective or non-conforming deliverables. If the City has the right to inspect the Contractor’s, or the Contractor’s Subcontractor’s, facilities, or the deliverables at the Contractor’s, or the Contractor’s Subcontractor’s, premises, the Contractor shall furnish, or cause to be furnished, without additional charge, all reasonable facilities and assistance to the City to facilitate such inspection.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum.

  • Response/Compliance with Audit or Inspection Findings A. Grantee must act to ensure its and its Subcontractors’ compliance with all corrections necessary to address any finding of noncompliance with any law, regulation, audit requirement, or generally accepted accounting principle, or any other deficiency identified in any audit, review, or inspection of the Contract and the services and Deliverables provided. Any such correction will be at Grantee’s or its Subcontractor's sole expense. Whether Xxxxxxx's action corrects the noncompliance shall be solely the decision of the System Agency.

  • Environmental Inspection at End of Agreement Term A. At Authority’s discretion, at least one hundred and twenty (120) days before the expiration or early termination of the Term as provided herein, Company will conduct an environmental inspection and examination of the Company Premises. At its discretion, Authority may complete environmental reviews to determine if recognized environmental conditions exist that could warrant soil and groundwater sampling. If warranted by the findings of Company or Authority’s inspection or if requested by Authority, a compliance audit or site assessment will be performed within the aforementioned time period by a qualified professional acceptable to Authority who will report the findings to Authority. The cost for professional consulting or engineering services required for such audit will be at the expense of Company. If a site assessment is conducted, Company agrees to pay all associated laboratory and testing fees incurred to test and analyze samples collected during the site assessment process. The Authority may also choose to conduct the compliance audit or site assessment. If the results of the assessment indicate that the Company Premises have been impacted by the release of Hazardous Substances, Company will immediately take such action as is necessary and will provide a substantial guaranty in a form and content acceptable to Authority that Company will clean up the contamination at its own expense, at no expense to Authority, and in accordance with Applicable Laws to the extent that it is obligated to do so by virtue of the foregoing provisions of this Article.

  • INSPECTION AND REJECTION 8.1 Purchaser shall have the right to inspect and test Products at any time prior to shipment, and within a reasonable time after delivery to the Purchaser’s Destination. Products not inspected within a reasonable time after delivery shall be deemed accepted by Purchaser. The payment for Products shall in no way impair the right of Purchaser to reject nonconforming Products, or to avail itself of any other remedies to which it may be entitled.

  • Updated Information Submission by Developer The updated information submission by the Developer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. Developer shall submit a completed copy of the Large Generating Facility data requirements contained in Appendix 1 to the Large Facility Interconnection Procedures. It shall also include any additional information provided to Connecting Transmission Owner for the Interconnection Feasibility Study and Interconnection Facilities Study. Information in this submission shall be the most current Large Generating Facility design or expected performance data. Information submitted for stability models shall be compatible with NYISO standard models. If there is no compatible model, the Developer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information. If the Developer’s data is different from what was originally provided to Connecting Transmission Owner and NYISO pursuant to an Interconnection Study Agreement among Connecting Transmission Owner, NYISO and Developer and this difference may be reasonably expected to affect the other Parties’ facilities or the New York State Transmission System, but does not require the submission of a new Interconnection Request, then NYISO will conduct appropriate studies to determine the impact on the New York State Transmission System based on the actual data submitted pursuant to this Article 24.3. Such studies will provide an estimate of any additional modifications to the New York State Transmission System, Connecting Transmission Owner’s Attachment Facilities, or System Upgrade Facilities or System Deliverability Upgrades based on the actual data and a good faith estimate of the costs thereof. The Developer shall not begin Trial Operation until such studies are completed. The Developer shall be responsible for the cost of any modifications required by the actual data, including the cost of any required studies.

  • County Review and Approval of Insurance Requirements The County reserves the right to review and adjust the Required Insurance provisions, conditioned upon County’s determination of changes in risk exposures.

  • Environmental Audit Upon reasonable notice, Director shall have the right but not the obligation to conduct or cause to be conducted by a firm acceptable to Director, an environmental audit or any other appropriate investigation of the Premises for possible environmental contamination. Such investigation may include environmental sampling and equipment and facility testing, including the testing of secondary contamination. No such testing or investigation shall limit Tenant’s obligations hereunder or constitute a release of Tenant’s obligations therefor. Tenant shall pay all costs associated with said investigation in the event such investigation shall disclose any Hazardous Materials contamination as to which Tenant is liable hereunder.

  • No Restriction on Existing Examination and Investigative Authority That this Agreement shall in no way preclude any State Mortgage Regulator from exercising its examination or investigative authority authorized under the laws of the corresponding Participating State in the instance a determination is made wherein Respondent is found not to be adhering to the requirements of the Agreement, other than inadvertent and isolated errors that are promptly corrected by Respondent, or involving any unrelated matter not subject to the terms of this Agreement. The Parties agree that the failure of Respondent to comply with any term or condition of this Agreement with respect to a particular State shall be treated as a violation of an Order of the State and may be enforced as such. Moreover, Respondent acknowledges and agrees that this Agreement is only binding on the State Mortgage Regulators and not any other Local, State or Federal Agency, Department or Office.

  • Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

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