Audity a monitorování Sample Clauses

Audity a monitorování. CRO, zadavatel a jejich zástupci mohou provést audit hlavního zkoušejícího a pracovníků studie, monitorovat je anebo se s nimi setkat u poskytovatele a v zařízení, kde probíhá studie, v průběhu běžné pracovní doby a s četností přiměřenou pro audity a návštěvy za účelem monitorování postupu studie a kontroly záznamů, dokumentů, informací, údajů a materiálů ze studie (včetně údajů shromážděných v průběhu provádění studie, jak je definováno v protokolu, a předkládaných CRO anebo zadavateli (dále jen „údaje ze studie“). Poskytovatel poskytuje součinnost a zajišťuje, aby i hlavní zkoušející a pracovníci studie poskytli součinnost CRO, zadavateli a jejich zástupcům při plánování takových návštěv. CRO, the Sponsor, and their Representative(s) shall be entitled to: (a) examine and inspect all the facilities required for the performance of the Study; (b) inspect Source Documents (as defined under ICH Guidelines; and (c) inspect, request correction of, and copy all Study Data (including, without limitation, Case Report Forms, original reports of laboratory tests and examination findings, and all other notes, charts, reports, or memoranda related to the Study Subjects or to the conduct of the Study), which CRO and the Sponsor are authorized to access by the signed informed consent form, and/or the Regulations. The Provider shall cooperate, and shall ensure that the Principal Investigator cooperates, with CRO and the Sponsor during audits and monitoring visits and in the resolution of any questions regarding the Study Data. CRO, zadavatel a jejich zástupce (zástupci) je oprávněn: (a) provádět kontroly a inspekce všech zařízení potřebných k provádění studie (b) provádět inspekce zdrojových dokumentů, jak jsou uvedeny ve směrnicích ICH, a (c) provádět inspekce, žádat opravy a kopírovat údaje ze studie (zejména formuláře pro záznamy o subjektech hodnocení, originálních zpráv z laboratorních testů a výsledků šetření, jakož i všech ostatních poznámek, grafů nebo zápisů souvisejících se subjekty hodnocení nebo s prováděním studie), k nimž budou mít CRO a zadavatel oprávněný přístup na základě podepsaného informovaného souhlasu anebo předpisů. Poskytovatel spolupracuje a zajišťuje, aby hlavní zkoušející spolupracoval s CRO a se zadavatelem v průběhu auditů a návštěv za účelem monitorování a při hledání řešení všech problémů týkajících se údajů ze studie.
AutoNDA by SimpleDocs

Related to Audity a monitorování

  • Contract Monitoring The criminal background checks required by this rule shall be national in scope, and must be conducted at least once every three (3) years. Contractor shall make the criminal background checks required by Paragraph IV.G.1 available for inspection and copying by DRS personnel upon request of DRS.

  • Independent Monitors 8.1 The BUYER has appointed Independent Monitors (hereinafter referred to as Monitors) for this Pact in consultation with the Central Vigilance to as Monitors) for this Pact in consultation with the Central Vigilance Commission (Names and Addresses of the Monitors to be given). 8.2 The task of the Monitors shall be to review independently and objectively, whether and to what extent the parties comply with the obligations under this Pact. 8.3 The Monitors shall not be subject to instructions by the representatives of the parties and perform their functions neutrally and independently. 8.4 Both the parties accept that the Monitors have the right to access all the documents relating to the project/procurement, including minutes of meetings. 8.5 As soon as the Monitor notices, or has reason to believe, a violation of this Pact, he will so inform the Authority designated by the BUYER. 8.6 The BIDDER(s) accepts that the Monitor has the right to access without restriction to all Project documentation of the BUYER including that provided by the BIDDER. The BIDDER will also grant the Monitor, upon his request and demonstration of a valid interest, unrestricted and unconditional access to his project documentation. The same is applicable to Subcontractors. The Monitor shall be under contractual obligation to treat the information and documents of the BIDDER/Subcontractor(s) with confidentiality. 8.7 The BUYER will provide to the Monitor sufficient information about all meetings among the parties related to the Project provided such meetings could have an impact on the contractual relations between the parties. The parties will offer to the Monitor the option to participate in such meetings. 8.8 The Monitor will submit a written report to the designated Authority of BUYER/Secretary in the Department/ within 8 to 10 weeks from the date of reference or intimation to him by the BUYER / BIDDER and, should the occasion arise, submit proposals for correcting problematic situations.

  • Program Monitoring The Contractor will make all records and documents required under this Agreement as outlined here, in OEC Policies and NHECC Policies available to the SRO or its designee, the SR Fiscal Officer or their designee and the OEC. Scheduled monitoring visits will take place twice a year. The SRO and OEC reserve the right to make unannounced visits.

  • Project Monitoring The Developer shall provide regular status reports to the NYISO in accordance with the monitoring requirements set forth in the Development Schedule, the Public Policy Transmission Planning Process Manual and Attachment Y of the OATT.

  • Audit Cooperation In the event either Party is audited by a taxing authority, the other Party agrees to cooperate fully with the Party being audited in order to respond to any audit inquiries in a proper and timely manner so that the audit and/or any resulting controversy may be resolved expeditiously.

  • Independent Auditor If: (a) the Provider is the Distributor and, acting reasonably, gives notice that the Records contain information about other industry participants that cannot reasonably be severed from the information relating to the Trader or that the information is commercially sensitive; or (b) the provider is the Trader and, acting reasonably, gives notice that the Records contain information about other industry participants that cannot reasonably be severed from information relating to the Distributor or that the information is commercially sensitive, then the Distributor or the Trader, as appropriate, will permit an independent auditor (the “Auditor”) appointed by the other party to review the Records and the other party will not itself directly review any of the Records. The Distributor or the Trader, as appropriate, will not unreasonably object to the Auditor appointed by the other party. In the event that the Distributor or the Trader, as appropriate, reasonably objects to the identity of the Auditor, the parties will request the President of the New Zealand Law Society (or a nominee) to appoint a person to act as the Auditor. The party that is permitted by this clause 31.5 to appoint an Auditor will pay the Auditor’s costs, unless the Auditor discovers a material inaccuracy in the Records in which case the other party will pay the Auditor’s costs. The terms of appointment of the Auditor will require the Auditor to keep the Records confidential.

  • Auditors The auditors whose report with respect to financial statements that is or will be incorporated by reference in the Registration Statement, the Basic Prospectus, any Preliminary Final Prospectus or the Final Prospectus are independent with respect to the Bank under the rules and regulations adopted by the International Federation of Accountants.

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

  • Information Technology Enterprise Architecture Requirements If this Contract involves information technology-related products or services, the Contractor agrees that all such products or services are compatible with any of the technology standards found at xxxxx://xxx.xx.xxx/iot/2394.htm that are applicable, including the assistive technology standard. The State may terminate this Contract for default if the terms of this paragraph are breached.

  • Certified and Minority Business Enterprises Reports Upon Customer request, the Contractor shall report to the requesting Customer the Contractor’s spend with certified and other minority business enterprises in the provision of commodities or services related to the Customer’s orders. These reports shall include the period covered, the name, minority code, and Federal Employer Identification Number of each minority business utilized during the period; commodities and services provided by the minority business enterprise, and the amount paid to each minority business enterprise on behalf of the Customer.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!