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; 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, 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.


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;

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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 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.

  • 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 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 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.

  • 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.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • 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.

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

  • 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.

  • 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.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

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

  • 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).

  • 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;

  • 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 Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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.

  • 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;