Study Duration definition

Study Duration means an indication of the standard length of time it takes to complete a Programme, as set out in our postgraduate tuition fees pages on the University of Liverpool Online Programmes Website; Kaplan means Xxxxxx Open Learning (Liverpool) Limited, an affiliate college of the University of Liverpool, incorporated and registered in England and Wales with company number 11979168, whose registered office is Palace House, 0 Xxxxxxxxx Xx, Xxxxxx XX0 0XX; Maximum Period of Registration means the maximum period in which your Programme must be completed. This can be found in our Code of Practice on Assessment; Net Tuition Fees means the tuition fees payable by you to study on your chosen Programme after deduction of approved discounts and/or scholarships (if any), as shown in your offer letter; Programme in these terms and conditions means a programme of study delivered online in partnership between the University and Kaplan, which leads to an award of the University; Start Date means the date on which the Programme you have accepted a place on commences; University means the University of Liverpool, an exempt charity, incorporated and registered in England and Wales as a Royal Charter Company with company number RC000660, whose address is the Foundation Building, 000 Xxxxxxxx Xxxx, Liverpool L69 7ZX; and
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Study Duration. Adverse events will be collected for the duration of all studies. Study completion (closure) is defined as later of: - the last dose of the study medication, - the last visit by the subject or patient or, - the last subject or patient contact (e.g., phone contact) with the Investigator or designee as defined in the protocol. SAEs that occur within thirty (30) days after this closure must be reported. For survival studies, only deaths (not all serious AEs), that occur after the thirty (30) day period (study completion for each patient) need be reported.
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Study Duration. Given two months for recruitment and with two study treatments provided 30 days apart, the anticipated study duration is six months. Table of Contents
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Examples of Study Duration in a sentence

  • The end of the study is the time point at which the last data items are to be reported, or after the outcome data are sufficiently mature for analysis, as defined in the section on Sample Size, Accrual Rate and Study Duration.

  • Study Duration: Estimated duration for the main investigational plan (e.g. from start of screening of first participant to last participant processed and finishing the study) Study Schedule: Month Year of First-Participant-In (planned) Month Year of Last-Participant-Out (planned) Investigator(s): Name(s) of Investigator(s) Full contact details Study Centre(s): Single-centre or multi-centre.

  • Expected Start Date:  Anticipated Total Study Duration:   Section II: STUDY SUMMARY NOTE: THIS IS NOT A SUBSTITUTE FOR THE FULL PROPOSAL.

  • If you take longer than the Indicative Study Duration to complete your Programme, there will be no additional fees charged and the maximum sum payable to Kaplan for your Programme will still be the Net Tuition Fees, subject to any increases outlined in section 5.5. If you are paying your Net Tuition Fees by monthly instalments, these will continue to be payable, even if you are on a study break, until the Net Tuition Fees have been paid.

  • The earned ECTS credits will be accepted pursuant to article 3.6 of this study program.Committee for Academic Evaluation and Evaluation of Study Duration can allow the student to take the elective course from the list of offered courses carrying up to 5 ECTS credits at another faculty of University of Rijeka.

  • Study Start February 1, 2006 Work Stopped Due to FDA Request for Redesign **** Total Study Duration **** All service areas initiated start-up associated tasks until notice that the protocol required redesign.

  • Participants, Study Duration, & DataFrom our original survey, we asked participants to indicate if they were interested in participating in a followup study.

  • Study Duration Clinical Category AHI Severity Patient ID Night Table 3.

  • Study Duration: Estimated time (in months) from when the study opens to enrollment until: (1) completion of data collection; and (b) final data analyses.

  • In-home unattended sleep apnea testing using HSAT + LCs. Study Duration Clinical Category AHI Severity Figure 6.


More Definitions of Study Duration

Study Duration. The total study duration for [**].
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Study Duration. The study will be conducted over 18 months (6-month recruitment period and 12-month treatment and follow up period).
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Related to Study Duration

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

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • 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.

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.

  • 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).

  • 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 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.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • 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.

  • 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 III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

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

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • 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 Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country 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 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 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 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Embryo/fetus means the developing human organism from conception until the time of birth.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Development Phase means the period before a vehicle type is type approved.