Study Documentation. For each Study, the Institution and the Principal Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation (as defined below) in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities as applicable, and in full compliance with the applicable Protocol and all Applicable Laws. For purposes of this Agreement, “Study Documentation” includes all records related to the Study Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable Study, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the Study. Study Documentation shall not include Subjects' medical records and other original source documents. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSOR. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Study personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC system and according to the CRF (as defined in Section 11.2). The CRF instructions will also provide the Institution with data entry instructions. Data entered in the EDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expense. When an electronic invalidated system that allows retrospective entry or correction of medical records data is issued, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expense. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to ...
Study Documentation. The Investigator and study staff have responsibility for maintaining a comprehensive and centralized filing system containing all study-related documentation. These files must be suitable for inspection by the Sponsor or the FDA at any time, and should consist of the following elements: patient files (complete medical records, laboratory data, supporting source documentation, and the Informed Consent); study files (the protocol with all amendments, copies of all pre-study documentation, and all correspondence between the IRB, site, and Sponsor); and drug accountability files, containing a complete account of the receipt and disposition of the study drug.
Study Documentation. 8. Evaluation of Results
Study Documentation. The Investigator will retain a copy of all study documents in accordance with local or FDA regulations, whichever are the more stringent. For information, the regulations of the FDA state that the Investigator will retain study documents:
Study Documentation. The Principal Investigator and study staff has the responsibility of maintaining a comprehensive and centralized filing system containing all study related documentation. These files must be suitable for inspection by LSO or the FDA at any time, and should consist of the following elements: Patient files, containing the completed medical records, laboratory data, supporting source documentation, and the informed consent; Study files, containing the protocol with all amendments, copies of all regulatory documentation, and all correspondence between the IRB and Sponsor; Drug accountability files, containing a complete account of the receipt and disposition of the drug and device. Records are to be available for two years after marketing application approval, or if the application is not approved or never submitted, two years after the last shipment and delivery of the material and the FDA is so notified. The files should not be destroyed until the official termination letter from the Light Science Oncology.
Study Documentation. Site shall, and shall cause PI to, fully disclose to Sponsor any and all Study Documentation (as defined below). Sponsor shall own all right, title and interest, including any patent, trade secret, trademark, copyright or other proprietary intellectual property rights (collectively, the “Rights”) in and to any and all Study Documentation (other than a Subject’s primary medical records) and Sponsor may utilize such Study Documentation in any way it deems legally appropriate. Site hereby irrevocably assigns, and Site shall cause PI and any applicable Study Staff Member to irrevocably assign, to Sponsor all of their respective Rights worldwide in and to such Study Documentation. “Study Documentation” means work, reports, writings, designs, methods, computer software and data recorded in any form, including electronic mail, that are created, developed, written, conceived or made by Site, PI or any Study Staff Member (whether solely or jointly with others) as a result of or in connection with the Study or the performance of Site’s obligations under this Agreement, including Study Data, but excluding any Manuscript (as defined udělení registrace v regionu, na který se vztahují pravidla ICH, a dokud neskončí jakékoliv řízení nebo zamýšlené řízení o udělení registrace v regionu, na který se vztahují pravidla ICH, nebo po dobu dvou let po formálním přerušení klinického vývoje hodnoceného přípravku nebo (ii) po takovou dobu, kterou požaduje platná legislativa, včetně metodických pokynů ICH, nebo (iii) po takovou xxxxx dobu, jak vyžaduje zadavatel, podle toho, co nastane později. Po skončení tohoto období, pokud si centrum bude přát zničit jakoukoli dokumentaci ke klinickému hodnocení nebo jiné podobné dokumenty, centrum bude o svém úmyslu informovat zadavatele a zadavatel bude mít 60 dnů od data přijetí takového oznámení o výše uvedeném na to, aby podle svého přání buď převzal do úschovy jakoukoliv dokumentaci ke klinickému hodnocení nebo jiné podobné dokumenty, u kterých centrum navrhuje likvidaci, nebo umožnil, aby centrum takovou dokumentaci ke klinickému hodnocení nebo jiné podobné dokumenty zničilo. 9. Vlastnictví dokumentace ke klinickému hodnocení a vynálezů. (a)
Study Documentation. The Engineer shall prepare an overall study report to document the study analyses, findings and recommendations. The report shall incorporate condensed versions of the interim technical memoranda prepared for the individual work tasks. The Engineer shall also recommend additional performance measures for evaluating modal transportation systems in terms of their: • Cost effectiveness and energy efficiency • Travel time costs/savings • Modal choice • Safety • Environmental impacts • Economic impact • Freight impacts • Other measures
Study Documentation. Provider shall, and shall cause Principal Investigator to, fully disclose to Sponsor any and all Study Documentation (as hodnocení. Poskytovatel bude uchovávat veškerou dokumentaci ke klinickému hodnocení (jak je definována níže) a jakoukoli další dokumentaci, jejíž uchovávání se požaduje podle platné legislativy. Poskytovatel zajistí bezplatnou archivaci studijní dokumentace na 5 let v souladu se zákonem č. 378/2007 Sb. a na dalších 10 let zajistí archivaci na náklady zadavatele, za roční poplatek . Na zpoplatněnou archivaci bude vystavena faktura po podpisu smlouvy. Zadavatel bude informovat poskytovatele 6 měsíců před koncem doby uchovávání. V případě potřeby, Xxxxxxx a poskytovatel projednají další uchovávání v dobré víře. V případě, že ZADAVATEL ve shora uvedené lhůtě nesdělí, jak má být naloženo s veškerou dokumentací ke klinickému hodnocení (dále jen “dokumenty”) ani nezaplatí další částku na archivaci, má se za to, že je Poskytovatel oprávněn k likvidaci dokumentů.
Study Documentation. By signing page 2 of this protocol, the investigator acknowledges that he/she has received appropriate information about the products being tested in the trial and assures the sponsor that he/she will comply with the protocol. No changes in this protocol can be made without the sponsor’s written approval. The investigator will supply the sponsor with: • Curricula vitae for all investigators involved in the trial • Signed protocol signature page The sponsor will supply the investigator with: • Clinical study protocol • Other relevant information about the study products • Sample informed consent form • Case report forms (CRFs)/instruction manual • Equipment for clinical measurements of CO in exhaled air and lung function
Study Documentation. (a) A "Completed Case Report Form" (“Completed CRF”) will mean a case report form (i) that has been completed by the Investigator in accordance with all FDA and Study requirements, (ii) for a patient who properly qualified, participated in and completed the Study in accordance with all Study requirements, and (iii) which InterMune determines can be used in all analyses of the Study results.
