Clinical Investigation Subject definition

Clinical Investigation Subject means a person recruited to participate in the Clinical Investigation.
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Examples of Clinical Investigation Subject in a sentence

  • Personal data (as defined in the Data Protection Act 1998) shall not be disclosed to the Sponsor by the Board save where this is required to satisfy the requirements of the Clinical Investigation Plan or for the purpose of monitoring, auditing or adverse event reporting or investigation, or in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

  • The Sponsor shall not disclose the identity of Clinical Investigation Subjects to third parties without prior written consent of the Clinical Investigation Subject, except in accordance with the provisions of the Data Protection Act 1998 and the principles set out in the NHS Scotland Code of Practice on Protecting Patient Confidentiality (August 2003), unless in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

  • Personal data (as defined in the Data Protection Act 1998) shall not be disclosed to the Sponsor by the Trust save where this is required to satisfy the requirements of the Clinical Investigation Plan or for the purpose of monitoring, auditing or adverse event reporting or investigation, or in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

  • Any right or remedy of a third party which existed or is available apart from the Third Party Rights Act is not affected; in particular, without limitation, any right of any Clinical Investigation Subject to claim compensation in accordance with the Clinical Investigation Compensation Guidelines referred to in Appendix 3.

  • The Sponsor shall not disclose the identity of Clinical Investigation Subjects to third parties without prior written consent of the Clinical Investigation Subject, except in accordance with the provisions of the Data Protection Act 1998 and the principles set out in the NHS Confidentiality Code of Practice (November 2003), unless in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

  • Personal data (as defined in the Data Protection Act 1998) shall not be disclosed to the Sponsor or CRO by the Board save where this is required to satisfy the requirements of the Clinical Investigation Plan or for the purpose of monitoring, auditing or adverse event reporting or investigation, or in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

  • Any right or remedy of a third party which existed or is available apart from the Third Party Right Act is not affected; in particular, without limitation, any right of any Clinical Investigation Subject to claim compensation in accordance with the Clinical Investigation Compensation Guidelines referred to in Appendix 4.

  • Neither the Sponsor nor CRO shall disclose the identity of Clinical Investigation Subjects to third parties without prior written consent of the Clinical Investigation Subject, except in accordance with the provisions of the Data Protection Act 1998 and the principles set out in the NHS Scotland Code of Practice on Protecting Patient Confidentiality (August 2003), unless in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

  • Any right or remedy of a third party, which existed or is available apart from the Third Party Right Act is not affected; in particular, without limitation, any right of any Clinical Investigation Subject to claim compensation in accordance with the Clinical Investigation Compensation Guidelines referred to in Appendix 4.

  • Personal data (as defined in the Data Protection Act 1998) shall not be disclosed to the Sponsor or CRO by the Trust save where this is required to satisfy the requirements of the Clinical Investigation Plan or for the purpose of monitoring, auditing or adverse event reporting or investigation, or in relation to a claim or proceeding brought by the Clinical Investigation Subject in connection with the Clinical Investigation.

Related to Clinical Investigation Subject

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • 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.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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 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.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • 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.

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

  • 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.

  • 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.

  • 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.

  • Abuse Investigation and Protective Services means reporting and investigation activities as required by OAR 407-045-0300 and any subsequent services or supports necessary to prevent further abuse as required by OAR 407-045-0310.

  • Site investigation means the collection and evaluation of data adequate to determine whether or not discharged contaminants exist at a site or have migrated or are migrating from the site at levels in excess of the applicable remediation standards. A site investigation shall be developed based upon the information collected pursuant to the preliminary assessment;

  • 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 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 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 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 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).