Regulated Clinical Investigation definition

Regulated Clinical Investigation means a Clinical Investigation where an Investigational Medical Device that is not CE Marked, or a CE Marked medical device being used for a new intended purpose, is being investigated following regulatory approval under the requirements of the Medical Devices Regulations 2002. “Regulatory Authority” includes, but is not limited to, the Medicines and Healthcare products Regulatory Agency, Notified Bodies, as defined in the Medical Devices Regulations 2002, the U.S. Food and Drug Administration, Japan Ministry of Health, Labour and Welfare, and the General Medical Council.
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Regulated Clinical Investigation means a Clinical Investigation where an Investigational Medical Device that is not CE Marked, or a CE Marked medical device being used for a new intended purpose, is being investigated following regulatory approval under the requirements of the Medical Devices Regulations 2002 (England, Scotland, Wales) or Regulation (EU) 2017/745 (Northern Ireland); Regulatory Authority means any regulatory authority responsible for the review and approval of the Clinical Investigation and the use of the Investigational Medical Device; Research means the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods, as defined by and within the scope of the Research Governance Framework; Research Governance Framework means the UK Policy Framework for Health and Social Care Research (Version 3.3, November 2017);
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Regulated Clinical Investigation means a Clinical Investigation where an Investigational Medical Device that is not CE Marked, or a CE Marked medical device being used for a new intended purpose, is being investigated following regulatory approval under the requirements of the Medical Devices Regulations 2002 (England, Scotland, Wales) or Regulation (EU) 2017/745 (Northern Ireland); Regulatory Authority means any regulatory authority responsible for the review and approval of the Clinical Investigation and the use of the Investigational Medical Device; Research means the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods, as defined by and within the scope of the Research Governance Framework; Research Governance Framework means the UK Policy Framework for Health and Social Care Research (Version 3.3, November 2017); Results means the research findings produced in the Clinical Investigation; SADE means Serious Adverse Device Effect and shall have the definition set out in EN ISO 14155:2020; Sub-Investigator means any individual member of Personnel designated and supervised by the Principal Investigator to perform Clinical Investigation related procedures and / or to make important Clinical Investigation related decisions within the Investigator Site; Timelines means the timelines set out in Appendix 1 for the completion of certain milestones; Trial Site The body contracted by this Agreement to conduct the Clinical Investigation;
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Examples of Regulated Clinical Investigation in a sentence

  • Until the Sponsor or CRO has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply any Investigational Medical Devices to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation.

  • Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site.

  • Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation.


More Definitions of Regulated Clinical Investigation

Regulated Clinical Investigation means a Clinical Investigation where an Investigational Medical Device that is not CE Marked, or a CE Marked medical device being used for a new intended purpose, is being investigated following regulatory approval under the requirements of the Medical Devices Regulations 2002 (England, Scotland, Wales) or Regulation (EU) 2017/745 (Northern Ireland); Regulatory Authority means any regulatory authority responsible for the review and approval of the Clinical Investigation and the use of the Investigational Medical Device; Results means the research findings produced in the Clinical Investigation; SADE means Serious Adverse Device Effect and shall have the definition set out in EN ISO 14155:2020; Site means the physical location(s) where the Clinical Investigation will be conducted, under the primary responsibility of the Principal Investigator, within the Trial Site; Site File means the file maintained by the Principal Investigator containing the documentation specified in EN ISO 14155:2020; Investigator Site Investigation Completion means the conclusion of all Clinical Investigation Plan required activities for all enrolled Clinical Investigation Subjects at the Investigator Site; Sub-Investigator means any individual member of Personnel designated and supervised by the Principal Investigator at the Site to perform Clinical Investigation related procedures and/or to make important Clinical Investigation related decisions; Timelines means the timelines set out in Appendix 1 for the completion of certain milestones;
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Related to Regulated Clinical Investigation

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

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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 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 IV Clinical Trial means a Clinical Trial conducted after Regulatory Approval of the applicable Product has been obtained from an appropriate Regulatory Authority as a condition to, or for the maintenance of, any Regulatory Approval, including a trial that would satisfy the requirements of 21 C.F.R. 312.85, as may be amended, or the foreign equivalent thereof.

  • Pivotal Clinical Trial means a human clinical trial of a product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ((a) and (b)):

  • FDA means the United States Food and Drug Administration or any successor agency thereto.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • Phase 2 Clinical Trial means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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.

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

  • 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.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • 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.