Protocol Synopsis definition

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. 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 procedural method and design of the applicable Study.
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Examples of Protocol Synopsis in a sentence

  • Protocol Synopsis Finalized **** Final Protocol available and submitted to FDA **** Commencement of Omnicare Work (Start Date) **** FDA Approval **** Site Initiation **** First Patient Enrolled — cohort 1 **** Last Patient Enrolled — cohort 1 (assumes excluding 21 screening days of final expanded cohort) **** Last CRF to Data Management Unit.

  • Given the influential roles of anxiety in language learning, particularly in the second language learning context, from the previous studies, it is considered beneficial to further assess the roles of anxiety in the English language classrooms and its impact on learning in the speaking classroom.

  • For each other Study that the Parties agree to perform under this Agreement, the Parties are to complete and execute a Study Plan, which, among other items, shall include the Protocol Synopsis or the Protocol for such Study and the obligations and activities to be performed by each Party in connection with such Study (including regulatory activities).

  • For purposes of this Agreement and the Protocol Synopsis, each capitalized term shall have the meaning ascribed to it in this Agreement.

  • A Protocol Synopsis for the initial Study has been agreed to by the Parties as of the Effective Date and is attached hereto as Appendix A.

  • The Parties agree to the Protocol Synopsis set forth in Appendix D.

  • A Clinical Protocol Synopsis must be provided as an attachment called "Clinical Protocol Synopsis.pdf" and must not exceed 12 pages.

  • The Clinical Protocol Synopsis is expected to include the following information: Brief and/or Official Protocol Title Focus of the Study Objectives: A brief description of objectives, including the primary objective and secondary objectives (in a few sentences).

  • Applications that lack the Clinical Protocol Synopsis are incomplete and will not be peer reviewed.

  • A Protocol Synopsis or agreed draft Protocol for the initial Study has been agreed to by the Parties as of the Effective Date and a draft Protocol is attached hereto as Appendix 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: (a) Trial objective; (b) Trial design, including primary and any secondary endpoints; (c) Patient population, including material inclusion and exclusion criteria; (d) Dosing schedule; (e) Summary statistical analysis plan; (f) List of potential clinical investigators; and (g) Proposed timeline and cost.
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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 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
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.

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

  • 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.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Kyoto Protocol means the protocol to the UNFCCC adopted at the Third Conference of the Parties to the UNFCCC in Kyoto, Japan on 11 December 1997 as may be amended;

  • 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 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 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 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • 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 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 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 a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Protocol Number 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:

  • 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).

  • Screening means the process to determine whether the person seeking assistance needs further comprehensive assessment.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • SOPs means standard operating procedures.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • 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.

  • Batch Record means the production record pertaining to a Batch.