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.
Clinical trial site means any hospital or institute or any other clinical establishment having the required facilities to conduct a clinical trial;
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.

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.

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

  • 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.

  • Vice Chair Jones mentioned her department initially was not very supportive about online policy and had a strict online learning policy.

  • Research Status of Drugs That NIH Deemed In Need of Pediatric Studies, by Patent Status Clinical trial site chosenPatent status YesNo Total On2(16.7%) 10 12Off7(17.9%) 32 39Total9(17.6%) 42 51 Source: Adapted from NIH, “List of Drugs for Which Pediatric Studies Are Needed; Notice,” Federal Register, vol.

  • 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.

  • 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.

  • Confirmation from support departments that their involvement is agreed (if applicable)Once all of the local document pack is received the JRCO will carry out the appropriate governance and quality assurance checks.Final JRCO sign-off is also dependent on Clinical trial site agreement signed off by Pre- award Imperial AHSC JRCO and sponsor organisation (if applicable).

  • We established three tasks (with different values) rather than two, in the following hierarchy: (1) Aviate defined attitude control of the plane (level, or appropriate pitch and bank).

  • The licence holder must notify the Regulator, in writing, of the final inoculation of the last trial participant at each Clinical trial site, within 30 days of the decision to cease the dealings.


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.
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;
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.

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 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.

  • 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.

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

  • 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.

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

  • 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 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).

  • 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 Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • 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;