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 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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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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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 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 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 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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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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Related to clinical trial protocol

  • 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 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 III Clinical Trial means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a marketing application that would satisfy the requirements of 21 CFR 312.21(c).

  • 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.

  • 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:

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

  • 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;