Clinical trial site definition

Clinical trial site means a medical facility in Australia such as a clinical trial facility and associated pharmacy, which are notified in writing to the Regulator for the purposes of conducting this clinical trial.
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Clinical trial site means any hospital or institute or any other clinical establishment having the required facilities to conduct a clinical trial;
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Clinical trial site means a clinical trial facility or hospital, in Australia, that is notified to the Regulator for the purposes of conducting clinical trials authorised by this licence.
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Examples of Clinical trial site in a sentence

  • Dr. Tasneem Ahmed, CEO, Pharma Professional Services (Pvt.) Ltd, A-93 Ettawah society, Ahsanabad, [near Gulshan-e-Maimar], Gadap Town, Karachi, wherein the request has been made to register their site with DRAP as Clinical trial site dated 15th January, 2019.After evaluation observations were communicated as per prerequisites of prescribed Form-I of the Bio-Study Rules 2017 on 23-01-2019.

  • Note that, provided that r is not of the special form stated in the theorem, there is no step that reduces ψ, thereby forcing ψ to be zero for every left normal form, which leads to an obvious loop (or termination, if only finitely many times a normal form is reached).Remark 24.

  • International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh - Remote inspection- Clinical trial site 26-28 July 2021 This inspection report is the property of the WHO Contact: prequalinspection@who.intAll files were labelled with study information.

  • The application is on Form-III of the Bio-Study Rules 2017 with fee of Rs. 100,000/- submitted vide slip number 6737083351.2. It is submitted that M/s Shaukat Khanum Memorial Cancer Hospital & Research Centre, Lahore was licensed (CTS-0004) to act as Clinical trial site situated 7-A, Khayaban-e-Firdousi, block R 3 M.A. Johar Town, Lahore.

  • Under this scheme, the person responsible for clinical trials at the site (i.e. the lead investigator at that site) completes a Clinical trial site self-certification form (see Form 11.2 in Schedule A of the Guideline on the Regulation of Therapeutic Products in NewZealand), providing a description of the site’s facilities and procedures and a list of key personnel.

  • Clinical trial site costs related to patient enrollment are accrued as patients are entered into the trial reduced by any initial payment made to the clinical trial site when the first patient is enrolled.

  • Clinical trial site costs related to patient enrollment are accrued and expensed as patients are entered into the trial.

  • Re-viva initiated the f irst clinical site in Bentonville, Arkansas with two patients dosed at the Pillar Clinical trial site led by its principal investigator, Fayz A.

  • Graph 5: Clinical trial audits by type* Graph 6: Clinical trial site audits by region Projects Site 54,3% Quality Checks of Risks 22,0% CRO 8,0% Other Unplanned 1,2%ProjectsProcess 14,5% BRIC 20,0% RoW 25,5% North America (US/CA) 25,5% Japan 11,0% Europe 18,0% 173 Audits 94 Site Audits The 133 Pharma audits included 26 Quality checks of risks and covered clinical trials in different chronic diseases: Rare Diseases (27%), Immuno-Inflammation (23%), Oncology (35%), Diabetes (11%) and Cardiovascular (4%).

  • In this chapter new definitions have been introduced for Clinical trial site, Biomedical and health research, Efficacy, GCP guidelines, Orphan drugs, Post trial access, registered pharmacist, similar biologic, Trial participants.


More Definitions of Clinical trial site

Clinical trial site means a hospital located in Australia and notified in writing to the Regulator for the purposes of conducting this clinical trial.
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Clinical trial site means an investigator site, Sponsor‟s office, contract research organization, data management center or any other establishment involved in a clinical trial;
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Clinical trial site means a medical facility in Australia such as a hospital and associated pharmacy or laboratory, which is notified in writing to the Regulator for the purposes of conducting this clinical trial.
Sample 1
Clinical trial site means any hospital or institute or any other clinical establishment having the required facilities to conduct a clinical trial ​
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Related to Clinical trial 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 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 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.

  • 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 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.

  • 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 II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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 IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed 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).

  • 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 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 Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

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

  • 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 Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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 II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 1 Trial means, with respect to a Product, a human clinical trial that is intended to initially evaluate the safety, metabolism and pharmacokinetics of such Product that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other than the United States.

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

  • 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;