Study Records Clause Samples

Study Records. Study records are managed in accordance with VA Privacy Act System of Records Notice, currently identified as “Veteran, Patient, Employee and Volunteer Research and Development Project Records-VA” (34VA12). VA will retain study records for this clinical trial in accordance with applicable regulations and VA policies. Study records may be destroyed thereafter in accordance with federal Privacy Act guidelines and VA Records Control Schedule 10-1.

Study Records. On behalf of Principal Investigator and itself, Institution will retain each Study Subject’s Study records, which include the Principal Investigator’s copies of all Study Data as well as relevant source documents (collectively, “Study Records”), under storage conditions conducive to their stability and protection, for a period of 15 years after termination of the Study unless CRO or Pfizer authorizes, in writing, earlier destruction. Institution agrees to contact Pfizer at prior to destroying any Study Records and Principal Investigator and Institution further agree to permit Pfizer to ensure that the Study Records are retained for a longer period if necessary, at Pfizer’s expense, under an arrangement that protects the confidentiality of the records (e.g., secure off-site storage).

Study Records. Institution, on behalf of Principal Investigator and itself, will retain each Study Subject’s Study records, which include the Principal Investigator’s copies of all Study Data as well as relevant source documents (collectively, “Study Records”), under storage conditions conducive to their stability and protection, for a period of 15 years after termination of the Study. Institution agrees to permit Pfizer to ensure that the Study Records are retained for a longer period if necessary, at Pfizer’s expense, under an arrangement that protects the confidentiality of the records (e.g., secure off-site storage).

Study Records. Výraz „záznamy klinického hodnocení“ znamená společně veškerou dokumentaci a jiné záznamy (v písemné či elektronické formě) související s prováděním klinického hodnocení, včetně dokumentace a záznamů týkajících se: (i) řešitelského centra, (ii) náboru, screeningu, posuzování, náboru a testování subjektů (včetně relevantních částí jiných souvisejících záznamů týkajících se těchto subjektů), (iii) procedur, testů a jiných aktivit prováděných během klinického hodnocení, a (iv) veškerých finančních záznamů souvisejících s prováděním klinického hodnocení. (a) The term “Study Records” shall mean, collectively, all documentation and other records (whether in written or electronic format) related to the conduct of the Study, including, without limitation, documentation and records concerning: (i) the Site;‌ (ii) the solicitation, screening, evaluation, enrollment and testing of subjects (including the relevant portions of other pertinent records concerning such subjects); (iii) the procedures, tests and other activities performed during the Study; and (iv) all financial records related to the conduct of the Study.

Study Records. In the event the Company believes in good faith that the Group has materially failed to comply with applicable laws, or in the event required by regulatory authorities, or to defend any claim or action against the Company, Study records (other than those to be provided in accordance with the Agreement) shall be made reasonably available to the Company for inspection during normal business hours; provided however, that (1) the records may be located at individual Member Institutions; (2) access to the records will be subject to the respective operating procedures of the individual institutions; and (3) the Company may be required to reimburse the Group and/or Member Institutions for reasonable time cost and expense (which may include without limitation, staffing and internal costs and expense) necessary to provide such access.

Study Records. The Recipient and the principal investigator shall, and shall cause all investigators to, prepare and maintain Original Biological Materials records in accordance with the protocol approved for the Research Study and applicable Law. Properly organized Research Study records must be maintained and assistance provided for routine inspections and audits of such records by Corautus’ authorized representatives at mutually agreed upon reasonable times, including portions of pertinent records for all patients in the Research Study. Without limiting the generality of the foregoing, Recipient shall maintain a clinical trial material accountability log to maintain records of the Original Biological Materials. The cost of these inspections shall be borne by Corautus.

Study Records. BDI Pharmaceuticals shall maintain and cause any subcontractors that it may use hereunder to maintain books and records, including, but not limited to protocols, protocol amendments, lab notebooks and raw data, relating to the conduct of any study conducted as part of the Projects (the "Study Data") for the longer of fifteen (15) years or five (5) years following regulatory approval of the product to which the Study Data relates. BDI Pharmaceuticals shall provide Sponsor with access to or copies of the Study Data, at Sponsor's expense, within five (5) business days' following Sponsor's written request therefor. In the event that BDI Pharmaceuticals plans to dispose of any Study Data following the conclusion of the time-frame stated above, BDI Pharmaceuticals shall provide Sponsor with thirty (30) days prior written notice and an option to transfer such records to Sponsor, at Sponsor's expense.

Study Records. (a) The term “Study Records” shall mean, collectively, all documentation and other records (whether in written or electronic format) related to the conduct of the Study, including without limitation, documentation and records concerning: (i) the Site; (ii) the solicitation, screening, evaluation, enrollment and testing of subjects (including the relevant portions of other pertinent records concerning such subjects); (iii) the procedures, tests and other activities performed during the Study; and (iv) all financial transactions related to the Study.

Study Records. 6.1 Case Report Forms will be provided to the Investigator along with Study supplies. The Investigator shall complete and review all Case Report Forms for completeness and accuracy, shall submit data in a timely manner and shall maintain complete records of patient identification, clinical observations and clinical supplies disposition. The Investigator shall also maintain independent case histories for each patient, in addition to the Case Report Forms provided to the Investigator. The Investigator is required to retain Study documents and maintain the master patient log in accordance with all applicable regulations. 6.2 THE INVESTIGATOR SHALL RECORD ALL ENTRIES ON CASE REPORT FORMS IN A TIMELY MANNER FOLLOWING EACH PATIENT VISIT. 6.3 The Study will have quality assurance audits that will be performed several times during the duration of the Study. During the term of this Agreement, the Institution and Investigator agree to permit representatives of POI and Sponsor to examine at any reasonable time during normal business hours (1) the facilities where the Study is being conducted, (2) raw Study data, and (3) any other relevant information (and to make copies) necessary for POI or Sponsor to confirm that the Study is being conducted in conformance with the Protocol and in compliance with applicable laws, regulations and regulatory guidelines. The applicable health regulatory authority also may conduct independent inspections of the Study under its jurisdiction. The Investigator and Institution shall cooperate fully in such audits and inspections.