Clinical Site definition

Clinical Site means an acute care or rehabilitation facility, a primary care setting, a long-term care facility, a nursing home, a residential care setting, or any other site identified by the board as providing clinical learning experiences for nursing students.
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Clinical Site means a site or institution that will participate in performance of the Study.
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Clinical Site means a third party that administers Contact, Screening and Enrollment of Eligible Patients for Clinical Research Trials.
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Examples of Clinical Site in a sentence

  • If you wish to voluntarily provide a dataset, please refer to the draft Guidance for Industry Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning” (available at the following link http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequire ments/UCM332468.pdf ) for the structure and format of this data set.

  • If you wish to voluntarily provide a dataset, please refer to the draft “Guidance for Industry Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning” (available at the following link http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequire ments/UCM332468.pdf ) for the structure and format of this data set.

  • To ensure consumer safety, vaccination sites will need an appointed Clinical Site Lead to navigate the onboarding process.

  • The Clinical Site Lead is accountable for meeting clinical safety and quality standards at their site, as well as supporting planning, clinical governance, quality, and safety management processes.Primary Care providers are a critical component of the New Zealand COVID-19 vaccination rollout.The Ministry-prepared Primary Care Onboarding Guide provides simple step-by-step guidance on how to become a COVID-19 vaccination site.

  • For Jury Duty, you must notify the Clinical Coordinator and Clinical Instructor at your Clinical Site as soon as possible.

  • Clinical Site: any off-campus location to which students or faculty are assigned for completion of program requirements including labs, internships, or practicums.

  • DAIDS contracts with a Clinical Site Monitoring Group (CSMG) to evaluate the quality and integrity of study data at MTN study sites.

  • The DAIDS Office of Clinical Site Oversight (OCSO) facilitates clinical research and verifies that sites are employing optimal safeguards for participants’ safety and engaging in high quality research practices.

  • Submit a Clinical Site Agreement for each facility which will be used as a clinical site.

  • Students are expected to arrive at the Clinical Site each day at least 15 minutes prior to the expected time.


More Definitions of Clinical Site

Clinical Site means a hospital, outpatient department, clinic, radiology practice, an office of a physician and surgeon, podiatrist or chiropractor, or any other place or building in which a person conducts radiologic technology.
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Clinical Site refers to the City of Xxxxx’x Xxxxx Animal Center, located at 0000 Xxxxxxxxxx Xxxx.
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Clinical Site. Use the full, correct name as listed in “Schedule of Option Availability”. In: Enter the time recorded by site personnel from the appropriate “Clinical Site Documentation” form. Be sure to indicate AM or PM. Out: Same as “In”.
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Clinical Site. A physical area where clinical education occurs.
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Related to Clinical Site

  • 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.

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

  • 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 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).

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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.

  • 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.

  • 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 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 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).

  • 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;

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Archaeological site means a geographic locality in Washington, including but not limited to, submerged and submersible lands and the bed of the sea within the state's jurisdiction, that contains archaeological objects.

  • Cell Site means the Communication Provider’s radio base station premises or Third Party CP radio base station premises;

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

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

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.