Study Documentation Sample Clauses

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 ...
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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.
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Study Documentation. 8. Evaluation of Results
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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:
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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.
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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)
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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
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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.
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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.
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Related to Study Documentation

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Closing Documentation The Buyer shall have received the following documents, agreements and instruments from the Sellers:

  • Medical Documentation The teacher must supply a letter from a medical 3 doctor, who treated the patient, stating that in his/her opinion, there is a strong 4 probability that the illness was contracted at school.

  • Tax Documentation Xxxxxx agrees to provide a completed IRS 1099 for its payments to, and Xxxxxxx agrees to provide IRS W-9 forms for, each of the following payees under this Settlement Agreement:

  • Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits, and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. It is important that you retain and keep safely all documents associated with your policy so that you can refer to them in the event of a claim.

  • Project Documentation All documentation provided to the City other than Project drawings shall be furnished on a Microsoft compatible compact disc.

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Source Documentation Accounting records must be supported by such source documentation as canceled checks, bank statements, invoices, paid bills, donor letters, time and attendance records, activity reports, travel reports, contractual and consultant agreements, and subaward documentation. All supporting documentation should be clearly identified with the Award and general ledger accounts which are to be charged or credited.

  • Closing Documentation, etc For purposes of determining compliance with the conditions set forth in §12, each Lender that has executed this Credit Agreement shall be deemed to have consented to, approved or accepted, or to be satisfied with, each document and matter either sent, or made available, by any Agent or any Co-Lead Arranger to such Lender for consent, approval, acceptance or satisfaction, or required thereunder to be consented to or approved by or acceptable or satisfactory to such Lender, unless an officer of the Administrative Agent active upon the Borrowers’ account shall have received notice from such Lender prior to the Closing Date specifying such Lender’s objection thereto and such objection shall not have been withdrawn by notice to the Administrative Agent to such effect on or prior to the Closing Date.

  • ENVIRONMENTAL DOCUMENTATION Each environmental service provided by the Engineer shall have a deliverable. Deliverables shall summarize the methods used for the environmental services, and shall summarize the results achieved. The summary of results shall be sufficiently detailed to provide satisfactory basis for thorough review by the State, The Federal Highway Administration (FHWA), and (where applicable) agencies with regulatory oversight. All deliverables shall meet regulatory requirements for legal sufficiency, and shall adhere to the requirements for reports enumerated in the State’s NEPA MOU.

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