Clinical Trial Documentation definition

Clinical Trial Documentation means all records, accounts, notes, reports, data, ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Clinical Trial that are not Clinical Trial Data, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as case report forms (“CRFs”) or electronic case report forms (“e-CRFs”), the Protocol, Investigator’s Brochure, and all other reports and records necessary for the evaluation and reconstruction of the Clinical Trial, but excludes source documents and records of Personal Information and medical records, which shall remain the confidential and proprietary property of Institution;
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Clinical Trial Documentation means all records, accounts, notes, reports, data, ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Clinical Trial that are not Clinical Trial Data, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as case report forms (“CRFs”) or electronic case report forms (“e-CRFs”), the Protocol, Investigator’s Brochure [NTD: Delete if not applicable], and all other reports and records necessary for the evaluation and reconstruction of the Clinical Trial, but excludes source documents and records of Personal Information and medical records, which shall remain the confidential and proprietary property of Institution;
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Clinical Trial Documentation means all records, accounts, notes, reports, data, ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Clinical Trial that are not Clinical Trial Data, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as CRFs, the Protocol, the Investigator Brochure, and all other reports and records necessary for the evaluation and reconstruction of the Clinical Trial, but excluding source documents and records of patient personal health information which shall remain the confidential and proprietary property of the Institution;
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Examples of Clinical Trial Documentation in a sentence

  • Institution shall use reasonable efforts to give [choose Sponsor or CRO to match contracting party] notice before destroying the Clinical Trial Documentation and Clinical Trial Data.

  • The Provider shall ensure that the Principal Investigator fully cooperates in the checks/inspections, including the provision of full Clinical Trial Documentation for review by the Company and/or Sponsor, upon appropriate safeguarding of the personal data protection and medical confidentiality.

  • The Recipient grants BMS, Ono, their respective Affiliates and (sub)licensees a Right of Cross-Reference to the Recipient Regulatory Documentation and the Combined Therapy Clinical Trial Documentation for the Recipient Study Drug or the Combined Therapy for the sole purpose of enabling BMS, Ono and their Affiliates and sublicensees to exercise its rights under clause (1) of this Section 8.3(b), which right shall survive any expiration or termination of this Agreement.

  • Upon reasonable notice, the Provider shall provide an authorized Company or Sponsor representative with an access to the Clinical Trial Venue and allow the Company and/or Sponsor to monitor and check whether and to what extent the Clinical Trial is conducted in compliance with this Agreement, Protocol and Regulations, including allowing inspection of all Clinical Trial Documentation.

  • The Recipient grants BMS and its Affiliates and (sub)licensees a Right of Cross-Reference to the Recipient Regulatory Documentation and the Combined Therapy Clinical Trial Documentation for the Recipient Study Drug or the Combined Therapy for the sole purpose of enabling BMS and its Affiliates and sublicensees to exercise its rights under clause (1) of this Section 8.3(b), which right shall survive any expiration or termination of this Agreement.

  • At Sponsor’s request and expense, the Institution or the Investigator shall retain the Clinical Trial Documentation and Clinical Trial Data after the expiry of the Retention Period.

  • The Institution shall use reasonable efforts to give Sponsor notice before destroying the Clinical Trial Documentation and Clinical Trial Data.

  • The Institution or the Investigator may prepare material for publication or presentation derived from the Clinical Trial Data and Clinical Trial Documentation.

Related to Clinical Trial 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

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • 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.

  • 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;

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.