Site Audits Sample Clauses

Site Audits. Representatives of the IRB or the Sponsor (or designee) may visit the study site to carry out an audit of the study in compliance with regulatory guidelines and company policy. Such audits will require access to all study records including source documents, CRFs, and other study documents. Direct access to these study records must be guaranteed by the Investigator, who must provide support for these activities at all times. Similar auditing procedures may also be conducted by agents of any Regulatory Authority reviewing the results of this study. The Investigator/institution should immediately notify the Sponsor if they have been contacted by a Regulatory Authority concerning an upcoming inspection. Accountability for the study medication at the study site is the responsibility of the Investigator. The Investigator will ensure that the study medication is used only in accordance with this protocol. Where allowed, the Investigator may choose to assign some of the study medication accountability responsibilities to a pharmacist or other appropriately trained individual. Study medication accountability records indicating the delivery date to the study site, inventory at the study site and dispensing/use will be maintained. These records will adequately document that the study medications were dispensed and returned as specified in the protocol and according to the randomization scheme. Accountability records for all study medications will include dates, quantities, batch/lot numbers, kit numbers, cartridge numbers, and patient numbers. The Sponsor (or its designee) will review study medication accountability records at the study site on an ongoing basis during the study. All used and unused supplies must be inventoried, accounted for, and returned to the Sponsor (or its designee), or if authorized, disposed of at the study site. Records of disposal must be maintained with the study records.
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Site Audits. Xxxxxxx (through Xxxxxxx R&D Global Research & Development Quality Assurance or any successor organization responsible for quality assurance for Xxxxxxx and its Affiliates) will be responsible for establishing audit plans for each clinical study assigned to a Party in the CDP. The provisions of Section 7.4.2 below shall govern audits of sites Manufacturing clinical supplies of Licensed Products.
Sample 1
Site Audits. 7.1 A party shall, where it or any member of its Group: (A) is proposing to make a submission to a Regulatory Authority for the purposes of approval of a new or revised product that has been, or will be, manufactured at the Estate by or on behalf of such party or any member of its Group; and/or (B) considers, in good faith and acting reasonably, that a Site Audit is likely to occur, give notice to the other party as soon as reasonably practicable in advance of that anticipated Site Audit. 7.2 Where the other party so requests, a party shall, subject to Clause 21, provide to the other party details of its proposed timetable of future submissions as referred to in Clause 7.1(A) as soon as reasonably practicable following such request. No party shall be under an obligation to disclose any confidential information about its Group or its business under this Clause 7.2 where it reasonably believes that such disclosure will prejudice its business interests.
Sample 1
Site Audits. ONCORE will allow ZELTIQ to perform quality assurance inspections and audits of ONCORE’s facility(ies) during regular business hours upon five (5) business days advance written notice to ONCORE. ONCORE will cooperate with ZELTIQ inspector and will provide ZELTIQ access to ONCORE’s files (electronic or paper) to properly perform any such inspection or audit. The audit may include records relating to manufacturing compliance with the applicable Specifications, compliance with quality control and, inspection reports procedures, design history requirements, compliance with US FDA GMP/QSR Regulations, regulatory compliance, CE xxxx certification records and procedures, and compliance with ISO and/or EN requirements as applicable.
Sample 1
Site Audits. Contractor shall conduct detailed site audits that thoroughly document and verify the existing conditions that will inform the system design and construction. Site Audits will be used to verify impacts to site the Site(s) as part of the construction project and shall be conducted within 21 days of Contract execution. It is the responsibility of the Contractor to document all existing conditions and demonstrate that the post-construction site conditions are equivalent to pre-construction conditions.
Sample 1
Site Audits. The City will reserve the right to do periodic Site Audits of the awarded Service Provider, if deemed necessary.
Sample 1
Site Audits. Supplier will have, at a minimum, an annual site audit of Supplier's Information Technology general controls including, but not limited to, information security, privacy, and confidentiality controls, performed by a recognized third-party audit firm, which shall be provided to Ameren within thirty (30) days of its completion. The audit shall comply with the requirements of the American Institute of Certified Public Accountants' (AICPA) attestation standards SSAE 18, or the equivalent standard recognized by the industry at the time of such report (the "SOC Report"). The SOC Report shall include both a Type I report and a Type II report, upon Ameren's written request. Ameren reserves the right to request additional site audits if a SOC Report has revealed a security issue, or a security incident involving Supplier has been identified, which Supplier shall complete within sixty (60) days from the date requested. Any control exceptions noted in the SOC Report or equivalent will be addressed in the report with management’s corrective action. The SOC Report shall be performed by a recognized third-party audit firm engaged by Supplier. Supplier shall provide Ameren with the results of each SOC Report with respect to Supplier's security measures relating to electronic data at all facilities where Ameren Data is stored or accessed during the term of this Contract, regardless of the location of such facilities: a. Supplier shall provide a copy of the related report and consents to the provision of copies of such report by Ameren to applicable regulators. b. The report or attestation shall contain Supplier's management’s response to the exception comments, if any are noted, together with appropriate target dates for completion of required changes. Supplier shall provide reasonable assistance to Ameren in meeting its audit and regulatory requirements relating to electronic data and system security, including: a. providing access to relevant books, records, and Ameren Data in Supplier's possession; b. permitting a narrated data center tour; and c. permitting auditors and examiners to conduct reviews via submitting questionnaires after any security breach that has or is likely to result in an unauthorized use or disclosure of Ameren Data, or the systems that house or handle such Ameren Data.
Sample 1

Related to Site Audits

  • Environmental Audits There are no environmental audits, evaluations, assessments, studies or tests relating to the Corporation except for ongoing assessments conducted by or on behalf of the Corporation in the ordinary course.

  • Contract Audits Eligible Purchaser represents and warrants that it shall cooperate with Enterprise Services, the Office of the State Auditor, federal officials, and/or any third party authorized by law or contract, in any audit conducted by such party pertaining to any Contracts that Eligible Purchaser has made purchases from pursuant to this Agreement, including providing records related to any purchases from such Contracts.

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Field Examinations On no more than one occasion per every consecutive 24 month period following the most recent field examination date, the Loan Parties will permit, upon reasonable notice, the Administrative Agent to conduct a field examination to ensure the adequacy of Collateral included in any Borrowing Base and related reporting and control systems (with the time of such engagement determined at the discretion of the Administrative Agent, or as requested by the Required Lenders); provided that (I) the Company shall be permitted to instruct the Administrative Agent to conduct a field examination if as of any date the most recently completed field examination (or the most recently completed update thereof, if applicable) is more than one year old and (II) the Administrative Agent may conduct a field examination at the discretion of the Administrative Agent, or shall conduct a field examination at the request of the Required Lenders if (a) the date of the most recently completed field examination (or the most recently completed update thereof, if applicable) is more than one year old and (b) either (i) Loans have been outstanding within the three months preceding such date or (ii) LC Exposure within the three months preceding such date has been greater than $200,000,000 at any time. Notwithstanding the foregoing, in addition to the field examinations permitted above (A) during any calendar year when Aggregate Availability is at any time less than the greater of (x) an amount equal to 20% of the Loan Cap Minimum then in effect and (y) an amount equal to 20% of the Loan Cap then in effect, one additional field examination shall be permitted at the discretion of the Administrative Agent or the Required Lenders per calendar year and (B) if an Event of Default has occurred and is continuing, there shall be no limitation on the number or frequency of field examinations. For purposes of this Section 5.12, it is understood and agreed that a single field examination may be conducted at multiple relevant sites and involve one or more relevant Loan Parties and their assets. All of the foregoing field examinations shall be at the sole expense of the Loan Parties. Notwithstanding the foregoing, the Lenders shall be permitted to conduct one additional field examination per calendar year at their own cost and expense.

  • 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.

  • SITE EXAMINATION Contractor has examined the Site and certifies that it accepts all measurements, specifications and conditions affecting the Work to be performed at the Site. By submitting its quote, Contractor warrants that it has made all Site examination(s) that it deems necessary as to the condition of the Site, its accessibility for materials, workers and utilities, and Contractor’s ability to protect existing surface and subsurface improvements. No claim for allowance of time or money will be allowed as to any other undiscovered condition on the Site.

  • Independent Audits The Department staff shall review annual independent audits for adherence to generally accepted auditing principles and to the Department’s audit instructions. Incomplete or incorrect audits may be returned to the Grantee for correction.

  • Field Examination The Administrative Agent or its designee shall have conducted a field examination of the Loan Parties’ Accounts, Inventory and related working capital matters and of the Borrower’s related data processing and other systems, the results of which shall be satisfactory to the Administrative Agent in its sole discretion.

  • State Audits Under Minnesota Statute § 16C.05, subdivision 5, the Contractor’s books, records, documents, and accounting procedures and practices relevant to any Work Authorization are subject to examination by the State and/or the State Auditor or Legislative Auditor, as appropriate, for a minimum of six years from the end of this Professional and Technical Services Master Contract.

  • Field Audits The Borrower shall permit the Bank to inspect the Inventory, other Tangible Assets and/or other business operations of the Borrower and each Subsidiary, to perform appraisals of the Equipment of the Borrower and each Subsidiary, and to inspect, audit, check and make copies of, and extracts from, the books, records, computer data, computer programs, journals, orders, receipts, correspondence and other data relating to Inventory, Accounts and any other Collateral, the results of which must be satisfactory to the Bank in the Bank’s sole and absolute discretion. All such inspections or audits by the Bank shall be at the Borrower’s sole expense, provided, however, that so long as no Event of Default or Unmatured Event of Default exists, the Borrower shall not be required to reimburse the Bank for inspections or audits more frequently than once each fiscal year.