Clinical Trial Participant definition

Clinical Trial Participant means an individual who is eligible and who has consented or, where applicable, whose legal representative has consented on behalf of the Clinical Trial Participant, to participate in the Clinical Trial;
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Clinical Trial Participant means a person enrolled to participate in the Clinical Trial according to criteria detailed in the Protocol;
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Clinical Trial Participant means an individual participating in a clinical trial and providing Personal Information to third parties Eupraxia has contracted with to conduct the trial.
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Examples of Clinical Trial Participant in a sentence

  • Within 30 days after the termination of this Agreement, Investigator shall deliver to [choose Sponsor or CRO to match contracting party] in writing a final accounting of: all Clinical Trial Participants that participated in the Clinical Trial; the Clinical Trial Participant visits completed in accordance with the Protocol during the Term; and all reasonable direct costs incurred in connection with any transfer of the Clinical Trial to another trial site.

  • Notwithstanding the above, medically necessary deviations from the Protocol for reasons of Clinical Trial Participant safety shall not nullify or minimize Sponsor’s indemnification obligations, as long as such deviations are consistent with prevailing standards of medical care.

  • The Sponsor has no liability for damages of any sort, including personal injury or property damage resulting from the use of [Sponsor Equipment], [Sponsor Resources] [or] [Vendor Property] except to the extent that: such damages were caused by the wilful misconduct, negligent acts or omissions of Sponsor or the Vendor; or a personal injury to a Clinical Trial Participant is one covered by the indemnity detailed in Appendix 3 of this Agreement.

  • Exported data includes Clinical Trial Participant information only (pseudo-anonymized).

  • The Sponsor/CRO (on behalf of the Sponsor) will report all SAEs to local health authorities, Independent Ethics Committees (IECs)/Independent Review Boards (IRBs) and Investigators as required by local regulations and Sponsor/CRO SOPs. Patients enrolled at sites in the European Union will be provided with a Clinical Trial Participant card at the time of Visipaque™ or saline administration.

  • Timing and compliance will be recorded in the CRF.At the time of the first dose women will be provided with a Clinical Trial Participant Alert Card which will include space to record any adverse effects.

  • Research Participant Concerns Clinical Trial Participant Concerns - CISCRP - Center for Infor ...

  • Clinical Trial Participant Concerns - CISCRP - Center for Infor ...

  • Note that we distinguish between two typesLet Π be a set of scenario parameters and Θ be a set of prim-itives.

  • Without prejudice to the foregoing if injury is suffered by a Clinical Trial Participant while participating in the Clinical Trial, the Sponsor agrees to operate in good faith the guidelines published in 2015 by The Association of the British Pharmaceutical Industry and entitled “Clinical Trial Compensation Guidelines” and shall request the Principal Investigator, to make clear to the Clinical Trial Participants that the Clinical Trial is being conducted subject to the Association Guidelines.


More Definitions of Clinical Trial Participant

Clinical Trial Participant means an individual participating in a clinical trial in the EU and providing personal information to third parties Eupraxia has contracted with to conduct the trial. Clinical Trial Participant has the same meaning as “Data Subject” under Article 4 of the GDPR.
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Related to Clinical Trial Participant

  • 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.

  • 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 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.

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

  • 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.

  • Program participant means an individual certified by the secretary as a program participant under Iowa Code section 9E.3.

  • 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 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 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.

  • 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.

  • 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 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 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 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.

  • Study Participant means a person recruited to participate in the Study.

  • 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.

  • Class Year Study means a Class Year Interconnection Facilities Study as that term is defined in OATT Section 25 (OATT Attachment S).

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

  • 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 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 III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • Drug-dependent person means a person who is using a

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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.