Audit and Monitoring by PSI Sample Clauses

Audit and Monitoring by PSI and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source documents; and (iii) 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 PSI and the Sponsor are Zdravotnícke zariadenie musí okamžite informovať zadávateľa a PSI o všetkých inšpekciách alebo vyšetrovaniach zo strany akéhokoľvek štátneho, vládneho alebo právneho orgánu (vrátane, okrem iného, EMA a americkej FDA), ktoré súvisia so skúšaním a o ktorých sa dozvedia. PSI, zadávateľ a/alebo ich zástupcovia majú právo byť prítomní a/alebo zúčastniť sa na takejto inšpekcii alebo na vyšetrovaní. Predtým, ako zdravotnícke zariadenie alebo skúšajúci poskytnú orgánu v súvislosti s inšpekciou alebo vyšetrovaním akékoľvek materiály alebo informácie, má PSI a zadávateľ právo na posúdenie, poskytnutie a/alebo komentáre k týmto materiálom a/alebo informáciám.
Sample 1
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Audit and Monitoring by PSI and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source documents; and (iii) 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 PSI and the Sponsor are authorized to access by the signed Informed Consent Form, and/or the Applicable Regulatory Requirements. The Investigator shall cooperate with PSI and the Sponsor during audits and monitoring visits and in the resolution of any questions regarding the Study Data.
Sample 1
Audit and Monitoring by PSI and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. Zdravotnické zařízení a Hlavní zkoušející neprodleně oznámí PSI každou regulační kontrolu nebo šetření týkající se Studie, kterou provádí státní nebo kterýkoli jiný regulační úřad (včetně EMA a americké FDA) a o níž se dozvědí. PSI, Zadavatel a/nebo jejich zástupci budou mít právo být přítomni u takových kontrol a šetření a/nebo se na nich podílet. PSI a Zadavatel budou mít právo revidovat, poskytovat a komentovat veškeré odpovědi ke všem materiálům a/nebo informacím předtím, než je Zdravotnické zařízení nebo Hlavní zkoušející poskytnou regulačnímu úřadu v souvislosti s inspekcí nebo šetřením.
Sample 1
Audit and Monitoring by PSI and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study;
Sample 1
Audit and Monitoring by PSI and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. The Sponsor or its designees undertake to notify the Institution of such visits at least three days in advance and the visits must not jeopardize common operation of the Institution. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source documents; and (iii) 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 PSI and the Sponsor are authorized to access by the signed Informed Consent Form, and/or the Applicable Regulatory nebo kterýkoli jiný regulační úřad (včetně EMA a americké FDA) a o níž se dozví. PSI, Zadavatel a/nebo jejich zástupci budou mít právo být přítomni u takových kontrol a šetření a/nebo se na nich podílet. PSI a Zadavatel budou mít právo revidovat, poskytovat a komentovat veškeré odpovědi ke všem materiálům a/nebo informacím předtím, než je Poskytovatel zdravotních služeb poskytne regulačnímu úřadu v souvislosti s inspekcí nebo šetřením. Poskytovatel zdravotních služeb též poskytne PSI a Zadavateli kopie všech dokumentů souvisejících se Studií, které byly poskytnuty inspektorům nebo auditorům, či které byly od nich obdrženy.
Sample 1
Audit and Monitoring by PSI and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source Poskytovatel a Hlavní zkoušející neprodleně oznámí PSI každou regulační kontrolu nebo šetiení týkající se Studie, kterou provádí státní nebo kterýkoli jiný regulační úiad (včetně EMA a americké FDA) a o níž se dozvědí. PSI, Zadavatel a/nebo jejich zástupci budou mít právo být piítomni u takových kontrol a šetiení a/nebo se na nich podílet. PSI a Zadavatel budou mít právo revidovat, poskytovat a komentovat veškeré odpovědi ke všem materiálům a/nebo informacím piedtím, než je Poskytovatel nebo Hlavní zkoušející poskytnou regulačnímu úiadu v souvislosti s inspekcí nebo šetiením.
Sample 1

Related to Audit and Monitoring by PSI

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • EVALUATION AND MONITORING The ORGANIZATION agrees to maintain books, records and other documents and evidence, and to use accounting procedures and practices that sufficiently and properly support the complete performance of and the full compliance with this Agreement. The ORGANIZATION will retain these supporting books, records, documents and other materials for at least three (3) calendar years following the year in which the Agreement expires. The COUNTY and/or the State Auditor and any of their representatives shall have full and complete access to these books, records and other documents and evidence retained by the ORGANIZATION respecting all matters covered in and under this Agreement, and shall have the right to examine such during normal business hours as often as the COUNTY and/or the State Auditor may deem necessary. Such representatives shall be permitted to audit, examine and make excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, and records of matters covered by this Agreement. These access and examination rights shall last for three calendar years following the year in which the Agreement expires. The COUNTY intends without guarantee for its agents to use reasonable security procedures and protections to assure that related records and documents provided by the ORGANIZATION are not erroneously disclosed to third parties. The COUNTY will, however, disclose or make this material available to those authorized by/in the above paragraph or permitted under the provisions of Chapter 42.56 RCW without notice to the ORGANIZATION. The ORGANIZATION shall cooperate with and freely participate in any other monitoring or evaluation activities pertinent to this Agreement that the COUNTY finds needing to be conducted.

  • Audit and Records A. The Contractor (and Contractor’s suppliers, vendors, subcontractors, insurance agents and other agents) shall maintain and the OWNER shall have the right to examine books, records, documents, accounting procedures and practices and any other supporting evidence deemed necessary by the OWNER to substantiate compliance with the terms of this Contract, including, but not limited to, costs and charges of whatever nature related to, incurred, and/or anticipated to be incurred, in the performance of this Contract. Such right of examination shall include inspection at all reasonable times of the Contractor’s office or facilities or such parts thereof as may be engaged in the performance of this Contract, and reasonable access to and cooperation by all Contractor personnel who have worked on or have knowledge related to the performance of this Contract. B. The OWNER and its Authorized Representative shall have the right to examine all books, records, documents, and any other data of the Contractor related to the negotiation, pricing, or performance of such Contract, including Change Orders and/or Supplemental Agreements for the purpose of evaluating the accuracy, completeness, and currentness of the cost or pricing data submitted. The right of examination shall extend to all documents necessary to permit adequate evaluation of the cost or pricing data submitted, along with computations and projections used therein. Proprietary/Trade Secret information pertaining to this contract may not be withheld from OWNER or its Authorized Representative. C. The Contractor’s, subcontractor’s and related agent and vendor organization’s documents, records and other evidence shall be subject to inspection and/or reproduction by the OWNER, its agents and Designative Representatives. Contractor, subcontractor, and related agent and vendor organizations shall provide the OWNER with retrievals of computer based records or transactions that the OWNER determines to be necessary to conduct the audit. There shall be no charge to the OWNER for reasonable user of the Contractor’s or subcontractor’s photocopy machine while conducting the audit, nor for any cost of retrieving, downloading to diskette, and/or printing any records or transactions stored in magnetic optical, microfilm, or other media. The Contractor, subcontractor, and related agent and vendor organizations shall provide all records and retrievals requested, within seven (7) calendar days. If requested, the Contractor shall submit a copy of such documents monthly for review by the OWNER. D. The documents, etc. described in paragraphs A. and B. shall be made available at the office of the Contractor at all reasonable times, for inspection, audit, reproduction, until the expiration of four (4) years from the date of final payment. The Contractor shall provide adequate and appropriate work space to conduct all inspections audits and reviews. The OWNER shall provide the Contractor with a reasonable advance notice of intended audit, inspections and reviews. 1. If this Contract is completely or partially terminated, the records relating to the terminated work shall be made available for a period of four (4) years from the date of final payment. 2. Records which relate to appeals or litigation or settlement of claims arising out of the performance of this Contract shall be made available for the period of four (4) years from the date of final disposition of such appeals, litigation, or claims. E. The Contractor shall insert an Article containing all the provisions of this Section 19, including this paragraph, in all subcontracts hereunder except altered as necessary for the proper identification of the contracting parties and the OWNER under this Contract. The Contractor shall submit copies to the OWNER of all subcontracts and changes to subcontracts pertaining to this Contract. Failure to submit such written contracts, or to insert this Section in all subcontracts hereunder, shall be reason to exclude some or all of the related payee’s costs from amounts payable to the Contractor pursuant to this Contract. F. In addition, where projects are funded wholly or in part by federal grants, the FAA, the Secretary of Transportation and the Comptroller General of the United States or any of their duly authorized representatives shall have access, for the purpose of audit and examination, to any books, documents, papers, and records of the recipient that are pertinent to grants received in accordance with CFR 49, Part 18, as it may be amended from time to time. G. If an audit or review in accordance with this Article discloses overcharges (of any nature), by Contractor, in excess of 5% of the total contract value, the cost of the OWNER’s audit shall be paid by the Contractor.

  • Audit, Inspection and Visitation The Adviser shall make available to the Trust during regular business hours all records and other data created and maintained pursuant to the foregoing provisions of this Agreement for reasonable audit and inspection by the Trust or any regulatory agency having authority over the Trust.

  • Audit and Testing 4.1 The Contractor shall conduct tests of the processes and countermeasures contained in the Security Plan ("Security Tests") on an annual basis or as otherwise agreed by the Parties. The date, timing, content and conduct of such Security Tests shall be agreed in advance with the Authority. 4.2 The Authority shall be entitled to send a representative to witness the conduct of the Security Tests. The Contractor shall provide the Authority with the results of such tests (in a form approved by the Authority in advance) as soon as practicable after completion of each Security Test. 4.3 Without prejudice to any other right of audit or access granted to the Authority pursuant to this Contract, the Authority shall be entitled at any time and without giving notice to the Contractor to carry out such tests (including penetration tests) as it may deem necessary in relation to the Security Plan and the Contractor's compliance with and implementation of the Security Plan. The Authority may notify the Contractor of the results of such tests after completion of each such test. Security Tests shall be designed and implemented so as to minimise the impact on the delivery Services. If such tests impact adversely on its ability to deliver the Services to the agreed Service Levels, the Contractor shall be granted relief against any resultant under-performance for the period of the tests. 4.4 Where any Security Test carried out pursuant to paragraphs 4.2 or 4.3 above reveals any actual or potential security failure or weaknesses, the Contractor shall promptly notify the Authority of any changes to the Security Plan (and the implementation thereof) which the Contractor proposes to make in order to correct such failure or weakness. Subject to the Authority's approval in accordance with paragraph 3.12, the Contractor shall implement such changes to the Security Plan in accordance with the timetable agreed with the Authority or, otherwise, as soon as reasonably possible. For the avoidance of doubt, where the change to the Security Plan to address a non-compliance with the Security Policy or security requirements, the change to the Security Plan shall be at no additional cost to the Authority. For the purposes of this paragraph 4, a weakness means a vulnerability in security and a potential security failure means a possible breach of the Security Plan or security requirements.

  • 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, inspection or investigation of the Grant Agreement 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. B. As part of the services, Grantee must provide to HHS upon request a copy of those portions of Grantee's and its Subcontractors' internal audit reports relating to the services and Deliverables provided to the State under the Grant Agreement. C. Grantee shall include the requirement to provide to System Agency (and any of its duly authorized federal, state, or local authorities) internal audit reports related to this Grant Agreement in any Subcontract it awards. Upon request by System Agency, Grantee shall enforce this requirement against its Subcontractor. Further, Grantee shall include in any Subcontract it awards a requirement that all Subcontractor Subcontracts must also include these provisions.

  • Reporting and Monitoring Please provide a brief description of the mechanisms proposed for this project for reporting to the UNDP and partners, including a reporting schedule.

  • OIG INSPECTION, AUDIT, AND REVIEW RIGHTS ‌ In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine or request copies of Xxxxxx’x books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Xxxxxx’x locations for the purpose of verifying and evaluating: (a) Xxxxxx’x compliance with the terms of this IA and (b) Xxxxxx’x compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by Xxxxxx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Xxxxxx and any of Xxxxxx’x employees or contractors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Xxxxxx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Xxxxxx’x employees and contractors may elect to be interviewed with or without a representative of Xxxxxx present.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

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