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. 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. 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:
(a) for a minimum of two years following the date a marketing application (New Drug Application or NDA) is actually approved for the drug for the proposed clinical indication; or
(b) if the FDA has been notified that no marketing application is to be filed by BioMedicines, or if the marketing application has been filed but is not approved by the FDA, then for a minimum of two years following the release date of the final report; or
(c) if neither a) nor b) applies, then for a minimum of fifteen (15) years after the completion or discontinuation of the study.
(d) The Investigator must obtain BioMedicines’s written permission before disposing of any records. If the Investigator relocates, retires or for any reason withdraws from the study, then the study records may be transferred to an acceptable person or institution with the written approval of BioMedicines. The Investigator agrees to maintain a complete and current record of all documentation associated with the study. All of the documents should be kept together. Each should be available for ready review. These study documents will include the:
(e) protocol, including the case report forms
(f) protocol approval page with all required signatures
(g) protocol amendments and approval pages
(h) signed FDA Form 1572 or similar local form as appropriate
(i) Investigator’s current curriculum vitae
(j) documentation of IRB or Ethics Committee approvals for the protocol, amendments, informed consent, and advertisements used by the investigator to recruit patients
(k) current clinical laboratory certification
(l) range of normal laboratory values
Study Documentation. Study Management & Oversight
Study Documentation. The Engineer shall prepare plans and reports to document the study analyses, findings, and recommendations. Plans and reports will incorporate condensed versions of the interim technical memoranda prepared for the individual work tasks. The organization and format of study documentation will be determined by the State in consultation with the Engineer.
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.
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. 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.
