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. Drug Accountability 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.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
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. 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. 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:
Sample 1
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:
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
AutoNDA by SimpleDocs

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.

  • 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 At the Administrative Agent’s sole option, the Administrative Agent shall have completed its field examinations of the Borrower’s books and records, assets, and operations which examinations will be satisfactory to the Administrative Agent in its sole and absolute discretion.

  • 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 Visits and Inspections; Regulatory Examinations During the term of this Agreement, authorized representatives of the Fund may conduct periodic site visits of the Transfer Agent’s facilities and inspect the Transfer Agent’s records and procedures solely as they pertain to the Transfer Agent’s services for the Fund under or pursuant to this Agreement. Such inspections shall be conducted at the Fund’s expense (which shall include costs related to providing materials, copying, faxing, retrieving stored materials, and similar expenses) and shall occur during the Transfer Agent’s regular business hours and, except as otherwise agreed to by the parties, no more frequently than twice a year. In connection with such site visit and/or inspection, the Fund shall not attempt to access, nor will it review, the records of any other clients of the Transfer Agent and the Fund shall conduct the visit/inspection in a manner that will not interfere with the Transfer Agent’s normal and customary conduct of its business activities, including the provision of services to the Fund and to other clients. The Transfer Agent shall have the right to immediately require the removal of any Fund representatives from its premises in the event that their actions, in the reasonable opinion of the Transfer Agent, jeopardize the information security of its systems and/or other client data or otherwise are disruptive to the business of the Transfer Agent. The Transfer Agent may require any persons seeking access to its facilities to provide reasonable evidence of their authority. The Transfer Agent may also reasonably require any of the Fund’s representatives to execute a confidentiality agreement before granting such individuals access to its facilities. The Transfer Agent will also provide reasonable access to the Fund’s governmental regulators, at the Fund’s expense, solely to (i) the Fund’s records held by the Transfer Agent and (ii) the procedures of the Transfer Agent directly related to its provision of services to the Fund under the Agreement.

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

  • 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.

  • Environmental Audits and Reports As soon as practicable following receipt thereof, copies of all final environmental audits, investigations, analyses and reports of any kind or character, whether prepared by personnel of Holdings or any of its Subsidiaries or by independent consultants, Government Authorities or any other Persons, with respect to significant environmental matters at any Facility that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect or with respect to any Environmental Claims that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect.

  • Environmental Matters; Environmental Reviews (a) Each Restricted Person will comply in all material respects with all Environmental Laws now or hereafter applicable to such Restricted Person as well as all contractual obligations and agreements with respect to environmental remediation or other environmental matters and shall obtain, at or prior to the time required by applicable Environmental Laws, all environmental, health and safety permits, licenses and other authorizations necessary for its operations and will maintain such authorizations in full force and effect.

  • Inspections The Servicer shall inspect the Mortgaged Property as often as deemed necessary by the Servicer in accordance with Accepted Servicing Practices to assure itself that the value of the Mortgaged Property is being preserved. In addition, if any Mortgage Loan is more than 45 days delinquent, the Servicer promptly shall inspect the Mortgaged Property and shall conduct subsequent inspections in accordance with Accepted Servicing Practices or as may be required by the primary mortgage guaranty insurer. Upon request, the Servicer shall produce an electronic report of each such inspection.

Time is Money Join Law Insider Premium to draft better contracts faster.