clinical trial protocol definition

clinical trial protocol means a document containing the background, objective, rationale, design, methodology including matters concerning performance, management, conduct, analysis, adverse event, withdrawal, statistical consideration and record keeping pertaining to clinical trial;
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clinical trial protocol means the protocol governing the UHN Planned Trial. The Clinical Trial Protocol may be amended from time to time by agreement of the Parties subject to funding being available to support the costs of changes as required by the amendment.
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clinical trial protocol means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial and includes any successive versions of the protocol and protocol amendments;
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Examples of clinical trial protocol in a sentence

  • As a result of the revised schedule of events in Clinical Trial Protocol Version 2.0 dated 23th November, 2017, and change in completed Patient fee set forth under the Study Patient budget table is deleted in its entirety and replaced with the following table: Na základě revidovaného harmonogramu úkonů v Protokolu klinického hodnocení, verze 2.0 ze dne 23.

  • Clinical Trial Protocol For the parent study, between May 2004 and July 2008, 19,083 apparently eligible patients were identified through initial screening of colonoscopy and pathology reports.

  • Xxxxxxxx stipulates that information regarding Remuneration, Payment Schedule, Investigator's Brochure, Clinical Trila Insurance contract and the Clinical Trial Protocol, are deemed significant by the Sponsor in the sense of the legal definition of a business secret (s.

  • Platobná schéma All payments will be based on the performed tasks for each patient, which are to be done according to the according BI Trial No. 1160.106 Flowchart and Clinical Trial Protocol.

  • Institution and Investigator confirm that they also deem the information about compensation (Section 4.4 of the Agreement), Payment Schedule (Appendix 1), Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance and Clinical Trial Protocol significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 7 hereof.

  • Xxxxx Title: President Title: CEO Signed: /s/ Xxxxx Xxxxx Date: [Illegible] 2010 Name: Xxxxx Xxxxx Title: CFO and Company Secretary 10/31 Appendix I Study Protocol Clinical Trial Protocol ACO-002.

  • Sponsor notes that information in this agreement or in any subsequent Individual Clinical Trial Agreement concerning compensation (Section 4.4 of the Agreement), Payment Schedule (Appendix 1), Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance and Clinical Trial Protocol deems such information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil 7.8 Označení obchodního tajemství.

  • Scope of Work/Services Performance of Service Provider tests according to Flowchart and Clinical Trial Protocol indicated Prof.

  • Veškeré platby podle této smlouvy jsou vázány na řádné a včasné provedení klinického hodnocení ve 1) The Sponsor undertakes to pay the Institution the price agreed as per Exhibit 1 for each subject that may be evaluated, if the Investigator conducts and completes the Clinical Trial as stipulated by this Agreement and the Clinical Trial Protocol.

  • Dohodnutá cena zahrnuje odměnu zhotoviteli za splnění veškerých úkolů popsaných v této smlouvě 1) The Sponsor undertakes, through BMS CR, to pay the Institution the price agreed as per Exhibit 1 for each subject that may be evaluated, if the Investigator conducts and completes the Clinical Trial as stipulated by this Agreement and the Clinical Trial Protocol.


More Definitions of clinical trial protocol

clinical trial protocol means protocol(s) of the Clinical Trial being conducted under the Final Plan. The Clinical Trial Protocol shall include the Phase III Protocol. Execution Copy September 4, 2008
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clinical trial protocol means a written summary description of one or more Clinical Trial(s), which generally includes information on the objectives, design, methodology, statistical considerations and organization of the Clinical Trial (and including amendments to such description).
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clinical trial protocol means the Clinical Trial action plan used by each research center in the Clinical Trial and describing the objectives, design, methodology, statistical considerations and organization of the Clinical Trial, including (1) how many people are in the trial, (2) who is eligible to participate in the trial, (3) what drugs participants will take, (4) what medical tests they will have and how often, and (5) what information will be gathered during the trial.
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clinical trial protocol means a document explaining the background, rationale and the objectives of the clinical trial and describes its design, methodology and the organization which is involved in such clinical trial and shall include the statistical considerations, the conditions under which the clinical trial is to be carried out and managed. The clinical trial protocol shall be dated and signed by the investigator, the institution involved in such clinical trial and the sponsor;
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Related to clinical trial protocol

  • 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 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 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.

  • 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 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 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 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 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.

  • 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 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 pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • 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:

  • 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.

  • 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 evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Step therapy protocol means a protocol or program that establishes the specific

  • 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 laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;