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.

  • 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.

  • 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.

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

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

  • 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.

  • 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.

  • VI.Dokumentace klinickéhohodnocení Clinical Trial Documentation Dokumentací klinického hodnocení se rozumí všechny záznamy Poskytovatele Hlavního zkoušejícího, popřípadě Studijního týmu shromážděné nebo vytvořené v přímé souvislosti s Klinickým hodnocením, ať již v písemné, elektronické nebo jiné podobě, včetně všech zaznamenaných původních pozorování a záznamů, a to v rozsahu v jakém jsou vyžadovány Protokolem.

  • The Clinical Trial Documentation is understood as any and all records made by the Provider, Principal Investigator, or the Research Team, respectively, collected or created in a direct connection with the Clinical Trial in the written, electronic or other form, including any and all recorded original observations and records within the extent required by the Protocol.

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 “Product Documentation” at xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

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

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Design Documentation means all schematics and test, assembly and package documentation relating to the Product, including all design, specification and assembly documentation and data files for Materials, which is necessary for the production, manufacture, qualification, testing and delivery of the Product to be attached as Exhibit A.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 BMS and that otherwise fit the foregoing definition.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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).