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

  • The Provider shall make the Clinical Trial Documentation available to the Company, Sponsor, respective government authorities and Ethical Committees in accordance with the Regulations.

  • Upon completion of the Clinical Trial, the Provider shall ensure that the Clinical Trial Documentation is kept for at least fifteen (15) years, or if longer, such period as required by the ICH Harmonized Tripartite Guideline for Good Clinical Practice.

  • Retrieved from http://www.olympic.org/Athens-1896-summer-olympicsAtkinson, R., & Flint, J.

  • 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.

  • 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.

  • In no event, including without limitation expiration of the foregoing retention periods, shall either Provider or Principal Investigator remove from the Clinical Trial Venue or destroy any Clinical Trial Documentation without the prior written consent of Sponsor.

  • Phase II Clinical Trial Documentation (including Protocol and Investigators Brochure) (SOW, Option 4, Milestone 25) To be negotiated.

  • Phase I Clinical Trial Documentation (including Protocol and Investigators Brochure) (SOW, Option 2, Milestone 9.b.) To be negotiated.

  • The Provider and the Principal Investigator shall collect and keep the complete Clinical Trial Documentation in accordance with this Agreement, Protocol and Regulations.

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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Clinical Trial means the initial introduction of a Licensed Product as an investigational new drug into humans as required in 21 C.F.R. § 312, designed to determine the metabolism and pharmacologic actions of the Licensed Product in humans, the side effects associated with increasing doses and, if possible, to gain early evidence on effectiveness, and also includes studies of drug metabolism, structure-activity relationships and mechanism of action in humans.

  • 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.