Trial Documentation Sample Clauses

Trial Documentation. For each Trial, the Institution and the Principal Investigator shall ensure that the preparation, maintenance and retention of complete, current, accurate, organized and legible Trial Documentation (as defined below) is performed 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 is in full compliance with the applicable Protocol and all Applicable Laws. For purposes of this Agreement, “Trial Documentation” includes all records related to the Trial Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable Trial at the Institution, 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 Trial as required by a Protocol and/or Applicable Laws. Trial Documentation shall not include Subjects' medical records and other original source documents or the information contained therein. 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 in writing. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Trial 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 medical record system that allows retrospective entry or correction of medical records data is used, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facili...
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Trial Documentation. Site shall, and shall cause Principal Investigator to, fully disclose to Sponsor any and all Trial Docu- mentation. Sponsor shall own all right, title and interest, including any patent, trade secret, trademark, copyright or other proprietary intel- lectual property rights (collectively, the “Rights”) in and to any and all Trial Docu- mentation (other than a Subject’s primary medical records) and Sponsor may utilize such Trial Documentation in any way it deems le- gally appropriate. In the event that any such Trial Documentation is copyrightable subject matter, such Trial Documentation shall be con- sidered “work made for hire”. In the event that any such Trial Documentation is not copy- rightable subject matter or is otherwise deemed for any reason not to be a “work made for hire”, Site hereby irrevocably assigns, and Site shall cause Principal Investigator and any ap- plicable Trial Staff Member to irrevocably assign, to Sponsor all of their respective Rights worldwide in and to such Trial Documentation. “Trial Documentation” means work, reports, writings, designs, methods, computer software and data recorded in any form, including elec- tronic mail, that are created, developed, writ- ten, conceived or made by Site, Principal In- vestigator or any Trial Staff Member (whether solely or jointly with others) as a result of or in connection with the Trial or the performance of Site’s obligations under this Agreement, in- cluding Trial Data, but excluding any original Subject medical records that are considered “Source Documents” (as defined by Interna- tional Conference on Harmonization (ICH) Guidance E6 “Good Clinical Practice”).
Sample 1
Trial Documentation. Please review the User Guide during the trial period so that You become familiar with the features and functions of the Services before You make Your purchase.
Sample 1

Related to Trial Documentation

  • Legal Documentation Pursuant to The DMB Act (Public Act 431, as amended) all leases must be approved as to legal form by the Attorney General’s office, which includes the submission of documentation necessary to evidence legal authority of Bidder to enter into the lease agreement, including the signatory’s authority to bind. For your convenience, a guideline indicating necessary legal documentation is included with this RFP. Failure to provide appropriate legal documentation may result in your proposal being rejected.

  • 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.

  • 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.

  • Additional Documentation Execute and deliver, or cause to be executed and delivered, any and all other agreements, instruments or documents which Lender may reasonably request in order to give effect to the transactions contemplated under this Loan Agreement and the other Loan Documents.

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

  • 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

  • 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:

  • 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.

  • 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.

  • 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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