Monitoring, Audits and Inspections Sample Clauses

Monitoring, Audits and Inspections. ‌ During the investigation, the monitor will have regular contacts with the investigative site. These contacts will include visits to confirm that the facilities remain adequate to specified standards and that the investigative team is carrying out the procedure stated in the investigational plan. All data must be accurately recorded in the Case Report Forms. Source data verification (a comparison of data in the CRF with the subject’s medical records and other records at the investigation site) with access to records will also be performed. The monitor or other sponsor personnel will be available between visits if the Investigator or other staff at the site needs information and/or advice. Authorized representatives of the study sponsor, and FDA, may visit the site to perform audits / inspections, including source data verification.
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Monitoring, Audits and Inspections. 11.1 The Institution and Investigator shall cooperate with Sponsor, Sponsor’s /designees and/or CRO and any governmental or regulatory authorities in their efforts to monitor, audit, or inspect the progress of the Study at the Site. Authorized representatives of Sponsor shall have the right, upon reasonable advance notice, and during regular business hours, to: (i) inspect the Institution’s facilities used for the performance of the Study; (ii) inspect and copy all data and work products related to the Study; and (iii) examine source documents and other medical records of Study Subjects reasonably necessary to monitor the Study.
Monitoring, Audits and Inspections a) Zdravotnické zařízení a Zkoušející budou spolupracovat se Zadavatelem, společností EastHORN a dalšími společnostmi pověřenými Zadavatelem, jakož a) Institution and Investigator shall cooperate with Sponsor, EastHORN and other companies authorized by Sponsor, as well as with national, foreign
Monitoring, Audits and Inspections. 1) The progress and conducting of the Study will be monitored by the CRO for which the Institution and the Investigator must allow direct access to all facilities used for the conduct of the Study, all devices used in the Study and to the information obtained during the Study as well as to the retrospective results of all clinical records, laboratory tests, examinations, hospital release records, health insurance reimbursement codes and other routine records about the Subjects included in the Study (ref. ICH Note for Guidance on Good Clinical Practice, Step 5, CPMP/ICH/135/95). The Investigator engages in receiving the CRA on a regular basis and in dedicating time to her/him. 4) Ak Skúšajúci zistí v priebehu Štúdie, že subjekt hodnotenia zaradený do Štúdie nevyhovuje alebo prestal vyhovovať jej kritériám, bez zbytočného odkladu bude o tom informovať CRO a po dohode so Zadávateľom ho na základe podpísaného súhlasu z priebehu Štúdie vyradí. 5)
Monitoring, Audits and Inspections. 1) The progress and conducting of the Study will be monitored by the CRO for which the Institution and the Investigator must allow direct access to all facilities used for the conduct of the Study, all devices used in the Study and to the information obtained during the Study as well as to the retrospective results of all clinical records, laboratory tests, examinations and other routine records about the Subjects included in the Study, which are not part of the medical records of clinical trial subjects (ref. ICH Note for Guidance on Good Clinical Practice, Step 5, CPMP/ICH/135/95). The Investigator engages in receiving the CRA on a regular basis and in dedicating time to her/him.
Monitoring, Audits and Inspections 

Related to Monitoring, Audits and Inspections

  • Audits and Inspections At any time during normal business hours and as often as the City may deem necessary, Service Provider shall make available to the City for the City’s examination all of Service Provider’s records and documents with respect to all matters covered by this Agreement and, furthermore, Service Provider will permit the City to audit, examine and make copies, excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, payrolls, records of personnel, conditions of employment and other data relating to all matters covered by this Agreement.

  • Tests and Inspections 5.2.1 Tests and Inspections shall comply with title 24, part 1, California Code of Regulations, group 1, article 5, section 4-335, and with the provisions of the Specifications.

  • Reports and Inspections It will:

  • TESTING AND INSPECTION 6.1 Pre-Commercial Operation Date Testing and Modifications

  • Audit and Inspection 9.1 The Recipient, without charge, will permit any officer or officers of the Commissioner, external auditing bodies (i.e. National Audit Office or Audit Commission) or their nominees, to visit its premises and/or inspect any of its activities and/or to examine and take copies of the Recipient’s books of account and such other documents or records as in such officers' view may relate to the use of Grant. In addition, examinations may be carried out into the economy, efficiency and effectiveness with which the Grant has been used. The Commissioner shall endeavour, but is not obliged, to provide due notice of his/her intent to conduct an audit.

  • Audits/Inspections Contractor agrees to permit the County’s Auditor-Controller or the Auditor- Controller’s authorized representative (including auditors from a private auditing firm hired by the County) access during normal working hours to all books, accounts, records, reports, files, financial records, supporting documentation, including payroll and accounts payable/receivable records, and other papers or property of Contractor for the purpose of auditing or inspecting any aspect of performance under this Contract. The inspection and/or audit will be confined to those matters connected with the performance of the Contract including, but not limited to, the costs of administering the Contract. The County will provide reasonable notice of such an audit or inspection. The County reserves the right to audit and verify the Contractor’s records before final payment is made. Contractor agrees to maintain such records for possible audit for a minimum of three years after final payment, unless a longer period of records retention is stipulated under this Contract or by law. Contractor agrees to allow interviews of any employees or others who might reasonably have information related to such records. Further, Contractor agrees to include a similar right to the County to audit records and interview staff of any subcontractor related to performance of this Contract. Should the Contractor cease to exist as a legal entity, the Contractor’s records pertaining to this Contract shall be forwarded to the County’s project manager.

  • Maintenance and Inspection Consultant shall maintain complete and accurate records with respect to all costs and expenses incurred under this Agreement. All such records shall be clearly identifiable. Consultant shall allow a representative of City during normal business hours to examine, audit, and make transcripts or copies of such records and any other documents created pursuant to this Agreement. Consultant shall allow inspection of all work, data, documents, proceedings, and activities related to the Agreement for a period of three (3) years from the date of final payment under this Agreement.

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