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

  • Clinical trial site shall have a policy of investigators handling over the trial case he /she to leave investigator will continue to be responsible for the trial until such time another investigator takes over the trial.

  • Clinical trial site agreement signed off by Pre-award Imperial AHSC JRCO and sponsor organisation (if applicable).

  • 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.

  • Procedures Performed at the Screening/Baseline Visit(s) D0 The following procedures/ assessments should be performed at Visit 1.

  • 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%).

  • Suppliers/Vendors shall bear all costs associated with the preparation and submission of the quote, and CRS will in no case be responsible or liable for those costs, regardless of the conduct or outcome of the solicitation.

  • Clinical trial site functions as a contact point only to a podstatně nahrazujících právních předpisů ve vztahu ke shora uvedeným právním normám, (společně “Příslušné právní předpisy”).

  • It was verified 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.intthat an ICF was provided for all the screened volunteers, regardless the outcome of the screening procedure, through review of randomly selected study specific ICFs. The clinical trial was carried out under conditions which ensured safety for the subjects.

  • IRB notification attached with the signature of applicant which is a conflict of interest.4Details of premises including layoutplan of the site.Complete layout of Hospital is attached insteadof Specific area/site for Clinical trial site.

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


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 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 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

Related to Clinical trial site

  • 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 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 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.

  • 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 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 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 BMS and that otherwise fit the foregoing definition.

  • 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.

  • Pivotal Clinical Trial means a clinical study of an investigational product in patients with the primary objective of confirming with statistical significance the 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.

  • 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. [***]

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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:

  • 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.

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