Study Subjects definition

Study Subjects means any patient that has consented to and is enrolled in a Sponsored Clinical Trial.
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Study Subjects means those subjects enrolled in the Study which meet all Protocol eligibility requirements and protocol procedures. Subjekty studie znamenají pacienty zařazené do Studie, kteří splňují veškerá kritéria pro zařazení stanovená Protokolem.
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Study Subjects means patients participating in the Study. 1.16 „Studijní subjekty“ znamenají pacienty, kteří se účastní Studie.
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Examples of Study Subjects in a sentence

  • Notwithstanding the foregoing, in the event Sponsor believes that immediate termination is necessary due to its evaluation of risks to enrolled Study Subjects, Sponsor may terminate this Agreement immediately.

  • However, if the Study is a survival study then Provider of Healthcare may terminate this Agreement only as it applies to the requirement to enroll new Study Subjects.

  • If there is any conflict between this Agreement and the Protocol, the Protocol will control as to any issue regarding treatment of Study Subjects, and the Agreement will control as to all other issues.

  • Because this Agreement relates to a clinical study, there will be acceptable safeguards employed in such an audit to ensure confidentiality and protect the privacy of the Study Subjects.

  • Medical Records: the Study Subjects’ primary medical records kept by the Institution on behalf of the Study Subjects including, without limitation, treatment entries, x-rays, biopsy reports, ultrasound photographs and other diagnostic images.

  • In the event a thirty (30) day notice period is determined by Provider of Healthcare or Sponsor to be insufficient notice based upon evaluation of risks to enrolled Study Subjects receiving the Study Drug, the parties will cooperate to safely withdraw subjects from drug treatment over a mutually agreeable period of time but in no event shall Sponsor's obligation to supply Study Drug hereunder extend beyond a reasonable period.

  • This Agreement will terminate when the Study is complete, which means the conclusion of all Protocol-required activities for all enrolled Study Subjects.

  • The Site shall ensure sufficient access is granted to the monitor to enable source data verification of the Study Subjects.

  • Upon Sponsor’s or Quintiles’ request, Site agrees that, for each listed or identified investigator or sub-investigator who is directly involved in the treatment or evaluation of Study Subjects, Investigator shall promptly return to Quintiles a financial and conflict of interest disclosure form that has been completed and signed by such investigator or sub-investigator, which shall disclose any applicable interests held by those investigators or sub-investigators or their spouses or dependent children.

  • If so specified in the Protocol and the informed consent document, Principal Investigator may collect and provide to CRO, Pfizer or their designee biological samples obtained from Study Subjects (e.g., blood, urine, tissue, saliva, etc) for testing that is not directly related to Study Subject care or safety monitoring, such as pharmacokinetic, pharmacogenomic, or biomarker testing (“Biological Samples”).


More Definitions of Study Subjects

Study Subjects means an individual who participates in a Clinical Study as a recipient of Study Drug(s).
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Study Subjects the individuals who voluntary participate in the clinical trial. Zaměstnanci Místa provádění klinického hodnocení: (sub)výzkumní pracovníci a výzkumný personál Místa provádění klinického hodnocení. Subjekty studie: osoby, které se dobrovolně účastní klinického hodnocení. Site staff: Name; contact details; personal data that is part of the investigator’s current curriculum vitae (such as professional qualification, education, employment); financial information.
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Study Subjects. Pseudonymized data of study subjects involved in the clinical trial, these data include the following categories: - health data; - biological samples Sensitive data transferred (if applicable) and applied restrictions or safeguards that fully take into consideration the nature of the data and the risks involved, such as for instance strict purpose limitation, access restrictions (including access only for staff having followed specialised training), keeping a record of access to the data, restrictions for onward transfers or additional security measures. - Minimalization, data collection only contains the data that is specified in the study protocol. Zaměstnanci Místa provádění klinického hodnocení: Jméno; kontaktní údaje; osobní údaje, které jsou součástí aktuálního životopisu Zkoušejícího (např. odborná kvalifikace, vzdělání, zaměstnání); finanční informace. Subjekty studie: Pseudonymizované údaje subjektů studie zapojených do klinického hodnocení, tyto údaje zahrnují následující kategorie: - zdravotní údaje; - biologické vzorky Předávané citlivé údaje (je-li to relevantní) a uplatňovaná omezení nebo ochranná opatření, která plně zohledňují povahu údajů a související rizika, jako je například přísné omezení účelu, omezení přístupu (včetně přístupu pouze pro pracovníky, kteří absolvovali specializované školení), vedení záznamů o přístupu k údajům, omezení pro další předávání nebo dodatečná bezpečnostní opatření.
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Study Subjects patients participating in the Study.
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Study Subjects means a person (or persons) who, in accordance with the Protocol, is (or are): (a) eligible to be enrolled in the Study; and (b) enrolled in the Study.
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Related to Study Subjects

  • 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.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.

  • 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).

  • Subsurface tracer study means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

  • Data Subjects means all individuals whose Personal Information we receive in the course of our banking relationship with you, including your direct and indirect beneficial owners, directors, officers and authorized persons.

  • 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 Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

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

  • 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 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.

  • Study Data shall have the meaning set forth in Section 8.1.

  • 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.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • 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 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.

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.

  • 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.

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

  • 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;

  • Clinical Trial means any human clinical trial of a Product.

  • 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 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.