Records Maintenance and Retention. Contractor shall create, maintain, safeguard, and disposition records in accordance with 36 Code of Federal Regulations (CFR) Chapter XII, -- Subchapter B, “Records Management” and the National Archives and Records Administration (NARA)-approved Records Disposition Schedules. Records retention standards are applicable for all classes of records, whether or not the records are owned by the Government or the contractor. The Government may waive application of the NARA-approved Records Disposition Schedules, if, upon termination or completion of the contract, the Government exercises its right under paragraph (c) of this clause to obtain copies of records described in paragraph (b) and delivery of records described in paragraph (a) of this clause.
Records Maintenance and Retention. Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Institution will retain these documents for the longer of: (i) at least 5 years after completion or earlier termination of the Trial at all participating institutions; (ii) 2 years after the last approval of a marketing application for the Compound in the United States, European Union and Japan; (iii) 2 years following notification from Gilead that it has formally discontinued clinical development of the Compound; or (iv) such other minimum retention period requirements as required by applicable law. Institution will notify Gilead in writing prior to destruction of any Trial-related records and, if requested by Gilead, shall transfer such records to Gilead at Gilead’s expense. Vedení a uchovávání záznamů. Zdravotnické zařízení bude vést přesné a adekvátní záznamy vztahující se k nakládání s Hodnoceným léčivem a k provádění všech požadovaných činností dle Protokolu na subjektech Klinického hodnocení, zejména písemné dokumenty, lékařské záznamy, grafy týkající se jednotlivých subjektů Klinického hodnocení „Case Report Forms” („CRFs”), účetní záznamy, poznámky, záznamy a protokoly a údaje. Zdravotnické zařízení uchová tyto záznamy do té události z následujících událostí, která nastane nejpozději: (i) nejméně 5 let od dokončení Klinického hodnocení nebo od data předčasného ukončení Klinického hodnocení ve všech zdravotnických zařízeních; (ii) 2 roky od posledního schválení žádosti o registraci Sloučeniny ve Spojených státech amerických, Evropské Unii a Japonsku; (iii) následující 2 roky po upozornění společnosti Gilead, že tato formálně ukončila vývoj Sloučeniny; nebo (iv) na základě jiných právních požadavků stanovených příslušnými právními předpisy. Zdravotnické zařízení písemně vyrozumí společnost Gilead před likvidací jakýchkoliv záznamů Klinického hodnocení, a pokud tak bude požadovat společnost Gilead, odevzdá takové záznamy společnosti Gilead, a to na její náklady. Inspection and Assistance with Regulatory Matters. Kontroly a součinnost v regulačních záležitostech.
Records Maintenance and Retention. Investigator and Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Institution and Investigator will retain these documents for the longer of: (i) at least 5 years after completion or earlier termination of the Trial at all participating institutions; (ii) 2 years
Records Maintenance and Retention. Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Institution will retain these documents for the longer of: (i) at least 5 years after completion or earlier termination of the Trial at all participating institutions; (ii) 2 years after the last approval of a marketing application for the Compound in the United States, European Union and Japan; (iii) 2 years following notification from Gilead that it has formally discontinued clinical development of the Compound; or (iv) such other minimum retention period requirements as required by applicable law. Institution will notify Gilead in writing prior to destruction of any Trial-related records and, if requested by Gilead, shall transfer such records to Gilead at Gilead’s expense.
Records Maintenance and Retention. Investigator and Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Institution and Investigator will retain these documents for the longer of: (i) at least 5 years after completion or earlier termination of the Trial at all participating institutions; (ii) 2 years after the last approval of a marketing application for the Compound in the United States, European Union and Japan; (iii) 2 společností Gilead nebo jeho zástupci, a to v souladu s příslušnými zákony, pravidly a vyhláškami. (iv) Instituce a Zkoušející zajistí, že prázdné a částečně použité balení Zkoušeného léčiva a jakékoli zbývající množství Zkoušeného léčiva při závěrečné návštěvě na Zkoušejícím centru nebo při předčasném ukončení této Smlouvy bude znehodnoceno nebo vráceno společnosti Gilead v souladu s Protokolem. (v)
Records Maintenance and Retention. The Grantee must retain all books, accounts, reports, files, and any other records relating to this program for a period of not less than 6 years from the date of the Department’s final expenditure report to the federal government, or until any litigation or audit findings have been resolved. These materials, along with all laptop/accessories must be produced for inspection, review and/or audit when required by the Department. The laptop must have an affixed label (provided by the Department) indicating that it was purchased with HAVA funds. For Federal audit and inventory purposes, the Grantee will also provide information to the Department pertaining to any maintenance that requires replacement of any laptop/accessories.
Records Maintenance and Retention. Investigator and Institution will maintain
Records Maintenance and Retention. Provider will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Provider will retain these documents for 15 years after completion or earlier termination of the trial. Provider will notify Gilead in writing prior to destruction of any Trial-related records and, if requested by Gilead, shall transfer such records to Gilead at Gilead’s expense. Documents will not contain names and personal information about the subjects, which could be used for subject identification.
Records Maintenance and Retention. Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Institution will retain these documents for the longer of: (i) at least 5 years after completion or earlier termination of the Trial at all participating institutions; (ii) 2 years after the last approval of a marketing application for the Compound in the United States, European Union and Japan; (iii) 2
Records Maintenance and Retention. Investigator and Institution will maintain adequate and accurate records relating to the disposition of the Trial Drug and the performance of all required Protocol procedures on Trial subjects, including but not limited to, written source documents, medical records, charts pertaining to individual Trial subjects, “Case Report Forms” (“CRFs”), accounting records, notes, reports, and data. Institution and Investigator will retain these documents for the longer of: (i) at least 5 years after completion or earlier termination of the Trial at all participating institutions; (ii) 2 years after the last approval of a marketing application for the Compound in the United States, European Union and Japan; (iii) 2 years following notification from Gilead that it has formally discontinued clinical development of the Compound; or (iv) such other minimum retention period requirements as required by applicable law. Institution or Investigator will notify Gilead in writing prior to destruction of any Trial-related records and, if requested by Gilead, shall transfer such records to Gilead at Gilead’s expense. 2.4 Inspection and Assistance with Regulatory Matters. (i) At reasonable times and upon reasonable notice, Gilead and its respective appointed representatives shall have the right to inspect, audit, and monitor the Trial Site, Institution’s facilities, and all records described in Section 2.3. Each of the Institution, Trial Site and Investigator will cooperate with Gilead and its modifikace balení Zkoušeného léčiva, musí tyto změny být předem písemnou formou schváleny společností Gilead. 2.2
