Common use of Regulatory Inspection Clause in Contracts

Regulatory Inspection. The Site shall notify Sponsor and its designee immediately by telephone or facsimile of any inquiries, correspondence, or communications with or from the FDA or any other governmental or regulatory authority relating to the Study. If a regulatory authority, including without limitation the FDA, requests permission to or does inspect the Site’s facilities or research records relating to the Study, the Site will cooperate with the regulatory authority’s representative(s) and permit such inspection, and will make all reasonable efforts to permit Sponsor to review the records before the inspection and be present and available during such inspections. The Institution shall provide sufficient and appropriate space as deemed needed by the Investigator and/or Sponsor for such inspections without delay at no additional cost to Sponsor. Investigator and appropriate Study personnel will be available during such inspection to comply with the legitimate requirements of the inspection and to explain and discuss records and documentation related to the Study. The Site shall provide to Sponsor or its designees, in writing and in an organized manner, copies of all materials, correspondence, statements, forms, and records that the Site receives, obtains, or generates in connection with any such inspection or in connection with any inquiries, communications, or correspondence from the FDA or any other governmental or regulatory authorities. The Site will make reasonable efforts to segregate, and not disclose, all documents and materials that are not required to be disclosed during such an inspection, including financial data and pricing information.

Regulatory Inspection. The Site shall notify Sponsor and its designee immediately by telephone or facsimile of any inquiries, correspondence, or communications with or from the FDA or any other governmental or regulatory authority relating to the Study. If a regulatory authority, including without limitation the FDA, requests permission to or does inspect the Site’s facilities or research records relating to the Study, the Site will cooperate with the regulatory authority’s representative(s) and permit such inspection, and will make all reasonable efforts to permit Sponsor to review the records before the inspection and be present and available during such inspections. The Institution shall provide sufficient and appropriate space as deemed needed by the Investigator and/or Sponsor for such inspections without delay at no additional cost to Sponsor. Investigator and appropriate Study personnel will be available during such inspection to comply with the legitimate requirements of the inspection and to explain and discuss records and documentation related to the Study. The Site shall provide to Sponsor or its designees, in writing and in an organized manner, copies of all materials, correspondence, statements, forms, and records that the Site receives, obtains, or generates in connection with any such inspection or in connection with any inquiries, communications, or correspondence from the FDA or any other governmental or regulatory authorities. The Site will make reasonable jakýchkoli jiných státních nebo regulačních úřadů. Řešitelské centrum vynaloží přiměřené úsilí, aby oddělilo a nezveřejnilo žádné dokumenty a materiály, které není potřeba v průběhu takovéto inspekce zveřejnit, včetně finančních údajů a informací o cenách. efforts to segregate, and not disclose, all documents and materials that are not required to be disclosed during such an inspection, including financial data and pricing information.