Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized Quintiles, Sponsor or regulatory authority personnel direct access to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Site shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Site’s facilities, and the Site shall permit Quintiles and Sponsor to attend any such inspections. The Site will make reasonable efforts to separate, and not disclose, all confidential materials that are not required to be disclosed during such inspections. The Investigator and the Institution, if any, shall be jointly responsible for maintaining essential Study documents for the time and in the manner specified by current good clinical practice (“GCP”) guidelines, local laws, and Sponsor requirements and shall take measures to prevent accidental or premature destruction of these documents. If the Investigator leaves an institution, then responsibility for maintaining Study records shall be determined in accordance with applicable regulations. If an investigator or subinvestigator leaves an institution or otherwise changes addresses, he or she shall promptly notify Sponsor and Quintiles of his or her new address. The Site represents and warrants that neither it, nor any of its employees, agents or other persons performing the Study under its direction, has been debarred, disqualified or banned from conducting clinical trials or is under investigation by any regulatory authority for debarment or any similar regulatory action in any country, and the Site shall notify Quintiles immediately if any such investigation, disqualification, debarment, or ban occurs.
Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized PRA, Sponsor or regulatory authority personnel direct access to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Institution shall immediately notify PRA of, and provide PRA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit PRA and Sponsor to attend any such inspections. Sponsor and/or PRA shall notify Site (Clinical studies department) on any dates of scheduled initiatory, close out and nebudou prozrazena ani zveřejněna žádná obchodní tajemství ani osobní údaje. Pro účely této Smlouvy taková obchodní tajemství zahrnují mimo jiné: informace o platbách uvedené v Příloze B, minimální cílový počet zařazení, očekávaný počet subjektů zařazených do Studie a očekávanou dobu trvání Studie. Strany se proto dohodly na verzi této Smlouvy pro uveřejnění, z níž byla odstraněna všechna obchodní tajemství a osobní údaje (dále jen „Dohodnutá forma Smlouvy“). Strany souhlasí s tím, že Zdravotnické zařízení zařídí uveřejnění Dohodnuté formy Smlouvy v Registru smluv do 30 dnů od data posledního podpisu této Smlouvy. Pokud Zdravotnické zařízení neuveřejní Dohodnutou formu v zákonné lhůtě 30 (třiceti) dnů, od Data posledního podpisu této Smlouvy, může ji uveřejnit Zadavatel nebo PRA. Pokud k podepsání této Smlouvy dojde 1. července 2017 nebo po tomto datu, Xxxxxx souhlasí s tím, že tato Smlouva nenabude účinnosti, dokud nebude v souladu s tímto ustanovením uveřejněna Dohodnutá forma Smlouvy (dále jen „Datum účinnosti“). V každém případě si PRA vyhrazuje právo neposkytnout Hodnocený přípravek, dokud nebude Smlouva uveřejněna v souladu s tímto ustanovením. V případě, že platnost Dohodnuté formy Smlouvy bude po jejím uveřejnění zpochybněna, Strany se vzájemně vyrozumí co nejdříve, jak jen to bude za rozumných předpokladů možné poté, co se o takovém zpochybnění dozví, a vyvinou společně úsilí k tomu, aby se dohodly na revidované Dohodnuté formě Smlouvy pro uveřejnění. Zdravotnické zařízení v žádném případě neuveřejnění tuto Smlouvu v jiné než Dohodnuté formě Smlouvy bez předchozího písemného souhlasu PRA a Zadavatele.
Inspection and Debarment. When given reasonable notice, the Institution agrees to allow authorized PRA, Sponsor or regulatory authority personnel direct access to the Institution’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Institution shall immediately notify PRA of, and provide PRA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit PRA and Sponsor to attend any such inspections. The Site will permit the Sponsor to comment in advance, when practicable, on any correspondence to a governmental or regulatory authority. The Institution will make reasonable efforts to separate, and not disclose, all confidential materials that are not required to be disclosed during such inspections. The Institution shall promptly take steps to correct any deficiencies found by any such audit or inspection by PRA, Sponsor or a regulatory authority. The Institution, shall be responsible for maintaining essential Study documents for 15 years after completing the Study and in the manner specified by current good clinical practice (“GCP”) guidelines, local laws, and Sponsor requirements and shall take measures to prevent accidental or premature destruction of these documents. If the Principal Investigator or sub-Investigator ceases to work in the Institution or otherwise changes addresses, or if he or she ceases to be an employee of Institution or is no longer able or willing to participate in the Study, the Institution shall immediately after such finding, notify PRA and Sponsor and provide them with actual address of the Principle Investigator and Sub-Investigators. PRA reserves the right to approve any replacement Principal Investigator. The Institution represents and warrants that neither it, nor, to its best knowledge, any of its employees, agents or other persons performing the Study under its direction, has been debarred, Poskytovatel v žádném případě neuveřejnění tuto Smlouvu v jiné než Dohodnuté formě Smlouvy bez předchozího písemného souhlasu PRA a Zadavatele. Zadavatel bere na vědomí, že Poskytovatel jakožto státní příspěvková organizace je povinna poskytnout na žádost třetí osoby informace podle zákona č. 106/1999 Sb., o svobodném přístupu k informacím.
Inspection and Debarment. Upon ten (10) business days’ prior written notice, Biotest agrees to provide Derma Sciences with access to Biotest’s records relating to the Clinical Services during normal business hours and at any of Biotest’s facilities where the documents are present, including the subject medical records, for monitoring, auditing, and inspection purposes. Further, Biotest shall immediately notify Derma Sciences, and provide copies, of any inquiries, correspondence or communications from any government or regulatory authority relating to the Clinical Services, including, but not limited to, requests for inspection. With respect to this latter, Biotest shall permit Derma Sciences to attend any such inspections. Biotest represents and warrants that, to its actual knowledge, neither it nor any of its employees, agents or other persons performing the Clinical Services is under investigation by any regulatory authority for debarment or any similar regulatory action in any country and Biotest shall immediately notify Derma Sciences if any such investigation, disqualification, debarment or ban occurs.
Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized Quintiles, Sponsor or regulatory authority personnel direct access to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes and to all facilities used by Site to conduct the Study. The Site shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Site’s facilities, and the Site shall permit Quintiles and Sponsor to attend any such inspections. The Site will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections. Quintiles and/or AstraZeneca shall have the right to review and approve in advance any responses that pertain to the Study. No such response shall contain any false or misleading information with respect to the Study, the Investigational Product, Quintiles or AstraZeneca. For fifteen (15) years after the completion by Institution and Investigator of all obligations in the conduct of the Study, or the early termination of the Study, the Institution and the Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation and medical records of all subjects in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities, and in full compliance with the Protocol and all Applicable Laws and shall take measures to prevent accidental or premature destruction of these documents. If the Investigator leaves an institution, then responsibility for maintaining Study records shall be determined in accordance with applicable regulations. If Investigator or a sub-investigator leaves an institution or otherwise changes addresses, he or she odovzdať výsledky Skúšania v rozsahu nevyhnutnom na to, aby sa zabránilo vážnemu zdravotnému riziku alebo aby sa takéto riziko zmiernilo, avšak za predpokladu, že Zdravotnícke zariadenie alebo Skúšajúci (podľa toho, čo sa vzťahuje) bude Zadávateľa informovať pred odovzdaním takýchto informácií a okamžite po ich odovzdaní.
