Protocol Synopsis definition

Protocol Synopsis means a written summary of the procedural method and design of the applicable Study. A Protocol Synopsis for the initial Study is attached hereto as Appendix A.
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Protocol Synopsis means a written summary of the Protocol.
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Protocol Synopsis means a written summary of the procedural method and design of the applicable Study.
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Examples of Protocol Synopsis in a sentence

  • A Protocol Synopsis, as governed by the approved IND, for the portion of the Global Initial Study in the PRC Territory has been agreed to by the Parties as of the Effective Date and is attached hereto as Annex A.


More Definitions of Protocol Synopsis

Protocol Synopsis. Protocol Synopsis shall mean, with respect to a proposed or planned clinical trial, a document containing the following information with respect to such clinical trial:
Sample 1
Protocol Synopsis. Statistical Methods *** Change: “All subjects who are randomized, take one or more doses of test material and have at least one post treatment efficacy measurement will be included in the analysis. Comparisons between treatments will be assessed using an *** with factors of ***, ***and *** and with ***. A step-down multiple comparison procedure will be used to compare each dose group with ***. That is, comparison with *** will start at the ***. If the statistical test is significant at ***, then the test will proceed to the *** also at the ***.” To: “All subjects who are randomized, take one or more doses of test material and have at least one post treatment efficacy measurement will be included in the analysis. Comparisons between treatments will be assessed using an *** with factors of ***, *** and *** and with *** for percent weight loss, and *** for percentage of subjects with at least 5% weight loss. A step-down multiple comparison procedure will be used to compare each dose group with ***. That is, comparison with *** will start at the ***. If the statistical test is significant at *** for both co-primary endpoints, then the test will proceed to the *** also at the ***.” Background *** Change: “Obesity is associated with numerous co-morbidities including dyslipidemia, coronary artery disease (CAD), hypertension, stroke and type 2 diabetes.(7), (9) Epidemiological data indicate that obesity is associated with *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. increased mortality,(10) and a recent study of over 500,000 individuals concluded that excess body weight during midlife, including overweight, was associated with an increased risk of death.(11)” To: “Obesity is associated with numerous co-morbidities including dyslipidemia, coronary artery disease (CAD), hypertension, stroke and type 2 diabetes.(7), (9) Epidemiological data indicate that obesity is associated with increased mortality,(10) and a recent study of over 500,000 individuals concluded that excess body weight during midlife, was associated with an increased risk of death.(11)”
Sample 1
Protocol Synopsis. Efficacy Endpoints *** Change: “The difference in percent of subjects who achieve a reduction in total body weight of at least 5% and at least 10% between randomization (baseline) and end of treatment (week 56) for *** and *** groups; and To: “The difference in percent of subjects who achieve a reduction in total body weight of at least 10% between randomization (baseline) and end of treatment (week 56) for *** and *** groups; and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1

Related to Protocol Synopsis

  • 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;

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

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

  • 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.

  • 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 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.

  • 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.

  • 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.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • 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;

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Screening means the evaluation process used to identify an individual's ability to perform activities of daily living and address health and safety concerns.

  • 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.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.