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CLINICAL DOCUMENTATION definition

CLINICAL DOCUMENTATION consists of certain services detailed in Exhibit 4-C, Appendix F.
Sample 1
CLINICAL DOCUMENTATION means copies of Seller's and its Affiliates' files (whether paper or electronic), in each case updated to reflect the most current NDA data as requested by the FDA and relating solely to the HFA Product, containing (i) case report forms, (ii) investigator data (i.e. names and curricula vitae of any investigators who have studied the Product), (iii) IMR (Investigational Material Returned) forms and (iv) clinical trial work on the HFA Product and all information arising therefrom, in the case of each of the foregoing to the extent that such information is in existence, in the possession of Seller or its Affiliates as of the Closing Date and is legally permitted to be assigned.
Sample 1

Examples of CLINICAL DOCUMENTATION in a sentence

  • The research is subject to all applicable local, state, and Federal regulatory requirements.APPENDIX 7‌‌ CLINICAL PROTOCOL AND SUPPORTING CLINICAL DOCUMENTATION Please note that in this appendix “Principal Investigator” (PI) refers to the Initiating PI.

  • PACT CLINICAL DOCUMENTATION Page 20450:55-5-1 Clinical record keeping system 450:55-5-2 Basic requirements450:55-5-3 Documentation of individual treatment team members 450:55-5-4 Initial assessment and treatment plan450-55-5-5 Comprehensive assessment 450-55-5-6 Treatment team meeting 450:55-5-7 Treatment planning450:55-5-8 Discharge450:55-5-9 PACT Progress note 450:55-5-10 Medication record 450:55-5-11 Other records content SUBCHAPTER 7.

  • Indications for the drug is applied for shall be supported by appropriate clinical information given under “PHARMACOLOGICAL AND CLINICAL DOCUMENTATION (Page 6 of 7)”.

  • For purposes of this Agreement, Confidential Information includes any materials, whether in oral, visual, written, electronic, or other tangible or intangible form that are designated as confidential or reasonably understood to be confidential under the relevant circumstances of disclosure.

  • INFORMATION & CLINICAL DOCUMENTATION SYSTEMS Guarding Our Patient’s Privacy All associates and students are expected to abide by the following HIPAA (Health Insurance Portability and Accountability act) requirements to protectpatient information.

  • March 2016NAME STUDENT ID# NUR TERM DOCTOR OF NURSING PRACTICE CLINICAL DOCUMENTATION CHECKLIST • All students are required to provide the necessary documentation requested below.• Students are required to submit this completed form to their clinical lab instructor at your first class.• Any student not having all items current and completed may be denied access to the clinicalsite by hospital/agency personnel in accordance with Affiliation Contracts and Agreements.

  • Sept 2020NAME STUDENT ID# NUR TERM DOCTOR OF NURSING PRACTICE CLINICAL DOCUMENTATION CHECKLIST • All students are required to provide the necessary documentation requested below.• Students are required to submit this completed form to their clinical lab instructor at your first class.• Any student not having all items current and completed may be denied access to the clinical site by hospital/agency personnel in accordance with Affiliation Contracts and Agreements.

  • Kim CLINICAL DOCUMENTATION FOR EVENT LOG VIEWING: A MEDICAL RECORD DESIGN AND USAGE PROPOSAL 1284 E.

  • PACT CLINICAL DOCUMENTATION Page 19450:55-5-1 Clinical record keeping system 450:55-5-2 Basic requirements450:55-5-3 Documentation of individual treatment team members 450:55-5-4 Initial assessment and treatment plan450-55-5-5 Comprehensive assessment 450-55-5-6 Treatment team meeting 450:55-5-7 Treatment planning450:55-5-8 Discharge450:55-5-9 PACT Progress note 450:55-5-10 Medication record 450:55-5-11 Other records content SUBCHAPTER 7.

  • The Moderator reassures him that if they’re enrolled in classes, their status will not be adversely impacted by school closing.

Related to CLINICAL DOCUMENTATION

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Product Documentation means the specific materials listed under “Documentation” at

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • User Documentation means explanatory and informational materials concerning the Company products, in printed or electronic format, which the Company or any Subsidiary has released for distribution to end users with such Company products, which may include manuals, descriptions, user and/or installation instructions, diagrams, printouts, listings, flow-charts and training materials, contained on visual media such as paper or photographic film, or on other physical storage media in machine readable form.

  • Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • ISM Code Documentation includes, in respect of a Ship:

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the Licensed Product, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications, and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences, or discussions with any Regulatory Authority).

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Marketing Material means customary bank books (including a customary “public” and “private side” version), information or offering memoranda, rating agency presentations and other information packages regarding the business, operations and financial condition and prospects of the Assets and Assumed Liabilities, including all information relating to the transactions contemplated hereunder.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Client Application means an application developed by Licensee that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • Limited Documentation Program The guidelines under which the Seller generally originates Mortgage Loans principally on the basis of the Loan-to-Value Ratio of the related Mortgage Loan and the creditworthiness of the Mortgagor.

  • Security Documentation means the Security Documentation applicable to the specific Services purchased by Client, as updated from time to time, and as made reasonably available by Securiti.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Flood Documentation means, with respect to each Mortgaged Property located in the United States of America or any territory thereof, (i) a completed “life-of-loan” Federal Emergency Management Agency standard flood hazard determination (to the extent a Mortgaged Property is located in a Special Flood Hazard Area, together with a notice about Special Flood Hazard Area status and flood disaster assistance duly executed by the Borrower and the applicable Loan Party relating thereto) and (ii) a copy of, or a certificate as to coverage under, and a declaration page relating to, the insurance policies required by Section 5.02(c) hereof and the applicable provisions of the Security Documents, each of which shall (A) be endorsed or otherwise amended to include a “standard” or “New York” lender’s loss payable or mortgagee endorsement (as applicable), (B) name the Collateral Agent, on behalf of the Secured Parties, as additional insured and loss payee/mortgagee, (C) identify the address of each property located in a Special Flood Hazard Area, the applicable flood zone designation and the flood insurance coverage and deductible relating thereto and (D) be otherwise in form and substance reasonably satisfactory to the Collateral Agent.

  • Instructional material means instructional content that is provided to a student, regardless of its format, including printed or representational materials, audio-visual materials, and materials in electronic or digital formats (such as materials accessible through the Internet). The term does not include academic tests or academic assessments.

  • Instructional materials means relevant instructional

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

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