STUDY DETAILS Sample Clauses

STUDY DETAILS. The precise location(s) of the trial site(s) and related plots are yet to be determined and will be confirmed by the Steering Committee. The EUP trial design is divided into two study designs (Trial A and Trial B). These may take place simultaneously or in sequence as decided by the Steering Committee. The objectives of the Field Trial A will be to quantify various parameters from a single release point. Site selection will be based on specific criteria. All sites will comply with the following criteria: • Total study area: minimum of 25 and maximum of 200 acres. These areas are based on the expected distribution of male Aedes aegypti from a single release point. For example, if the maximum distance travelled is ~180 m, that equates to a circle with an area of 25 acres based around a single mosquito release point. If the maximum distance travelled is ~500 m, that equates to a circle with an area of 200 acres based around a single mosquito release point. Most studies have found the maximal distance travelled by wild Aedes to be between 82 and 400m, this being heavily influenced by climatic conditions, presence of vegetation and the availability of breeding sites (Xxxxxx et al., 1995; Xxxx & Xxx, 1998; Xxxxxxx et al., 2005). Previous field releases of OX5034 male mosquitoes in Brazil have recorded maximum dispersal distances of 198 m. • As requested by EPA, trial areas will be separated by at least 500m and if mosquitoes are trapped at the perimeter of a Trial A area, then additional ovitraps will be installed at distances greater than 400 m from the release site to capture any mosquitoes that may travel further. These additional traps may be constrained in terms of direction by available land mass, although every effort will be made to accommodate the distances required. Water bodies such as canals or ponds up to approximately 100m across will be considered not to impact dispersal. • Confirmed presence of Aedes aegypti (based on surveillance data). • Available documentation of mosquito abatement (other than experimental treatment) during the period of study. Treated and untreated areas of the EUP will be chosen to be as similar as possible, including in terms of any known mosquito abatement activity. • The outer boundary of the trial area (denoted by the traps furthest from the central release point) will be greater than 500 m from commercial citrus growing areas and from sewage treatment plants. Figure 1. Schematic overview of a trial site for Trial A show...
Sample 1
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STUDY DETAILS. The Partner programme will be delivered in English and assessed in English. The York St Xxxx programme will be assessed in English. Application forms must be received by the Admissions Team at York St Xxxx University, no later than six weeks prior to the expected date of transfer to York St Xxxx University. Students wishing to enrol for programmes at York St Xxxx University, other than those listed in this agreement are welcome to apply. Such applications will be considered on an individual basis This agreement is based on the current curriculum offered by York St Xxxx University. The University will inform the Partner about any changes to its programmes relevant to the consequences of this agreement In the event of the Partner ceasing to trade, York St Xxxx University will continue to accept students that have completed their studies and have met the conditions of entry specified in this Articulation Agreement The University will undertake to review and feedback on the Partner’s proposed marketing materials within two weeks of receipt. The Partner will ensure that its portfolio of programmes has all the necessary regulatory and statutory authority to operate and that any terms or conditions required are met in full. The Partner will be responsible for the recruitment and recommendation of students to the University. The Partner will provide the Admissions team at York St Xxxx University with a full transcript of results for all students applying to York St Xxxx University as soon as results are confirmed. This agreement is based on the current curriculum offered by the Partner. Any changes made by the Partner will be notified to York St Xxxx University in advance of the changes. This may result in a suspension of this agreement until the new curriculum has been reviewed and approved by the University. If changes occur without notification, this agreement will be terminated. The Partner is responsible for informing their students about any changes and their consequences for this agreement. The Partner shall inform the University immediately of any change of ownership or governance at the Partner Institution. The University reserves the right to re-negotiate any collaborative agreement if there is a change of ownership of governance of the Partner institution. The Partner will submit marketing materials to the University for approval a minimum of six weeks before they are due to be published. On admission to York St Xxxx University, students will be subject...
Sample 1
STUDY DETAILS. The [Partner] programme will be delivered in [language] and assessed in [language]. The Nottingham programme will be delivered and assessed in English.
Sample 1
STUDY DETAILS. This statistical analysis plan (SAP) covers the Phase II (Part B) of the study only. The Phase I safety run-in part (Part A) of the study is not covered in this SAP.
Sample 1
STUDY DETAILS. Academic year: 2023-2025 Study Cycle: ☐ 1st cycle (Bachelor) ☐ 2nd cycle (Master) ☐ State Examination ☐ PhD (Promotion) Subject area: Tap here to enter text. Degree: Tap here to enter text. Number of completed higher education study years (prior to mobility): Tap here to enter text. Called hereafter „the participant“, on the other part, have agreed the Special Conditions and the annexes below which form an integral part of this agreement („the agreement“): Annex I Learning Agreement for Erasmus+ mobility for traineeships Xxxxx XX General conditions Shall be filled in by the International Office! ISCED code: _____________ The participant receives: ☐ a financial support from Erasmus+ EU funds ☐ a zero-grant ☐ a partial financial support from Erasmus+ EU funds ☐ Base amount for individual support for long-term physical mobility ☐ Base amount for individual support for short-term physical mobility ☐ Top-up amount for students and recent graduates with fewer opportunities on long-term mobility ☐ Top-up amount for students and recent graduates with fewer opportunities on short-term mobility ☐ Top-up amount for traineeships ☐ Green travel top-up ☐ Travel support (standard travel or green travel amount) ☐ Travel days (additional individual support days) ☐ Exceptional cost for expensive travel (based on real costs) ☐ Inclusion support (based on real costs)
Sample 1
STUDY DETAILS. Please outline, in terms that any non-expert would understand, what your research project is about, including what participants will be required to do. 10) Subject selection: Yes No NA Version No. Effective Date Page a) Will subjects from both genders be recruited? ☐ ☐ ☐ b) Number of subjects to be recruited globally c) Number of subjects to be recruited in India d) Number of subjects to be recruited at MNR-MC 11) Aim and Objectives of Study (i.e. what is the intention of the study, key research questions?) 12) Specify the primary research question/objective 13) Specify the secondary research questions/objectives 14) Scientific justification for the clinical trial? 15) What are the inclusion criteria? 16) What are the exclusion criteria? Version No. Effective Date Page 17) What criteria exist for withdrawing research participants prematurely? 18) Scientific justification for the clinical trial? 19) Brief Study Procedure & Investigations (paste Study Flow Chart table) 20) Anticipated risks to participants (what, when, how often). Such risks could include physical stress, emotional distress, perceived coercion e.g. lecturer interviewing own students. Detail the measures and considerations you have put in place to minimize these risks. 21) Will treatment be withheld from research participants as a result of taking part in the clinical trial? ☐ Yes ☐ No If Yes, please give details Version No. Effective Date Page 22) What procedures are in place to monitor the health of the research participants during the trial or when they are no longer involved in the trial? 23) What are the potential benefits for research participants? 24) Proposed start date and duration of study Estimated close date: Duration (months): 25) Research location and in what setting? 26) Forms of obtaining consent ☐ Audio only ☐ Paper only ☐ Assent ☐ Audio & Video ☐ AV & Paper ☐ 27) Clinical phase of study ☐ Pilot investigation ☐ Phase 1 ☐ Post-marketing surveillance ☐ Pivotal investigation ☐ Phase 2 ☐ BA-BE ☐ Pilot performance (IVD) ☐ Phase 3 ☐ Single center ☐ Pivotal performance (IVD) ☐ Phase 4 ☐ Multi center 28) Does the study involve investigations and/or interventions Yes No a) Self completion questionnaire ☐ ☐ b) Audio/video tape recording ☐ ☐ Version No. Effective Date Page
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Related to STUDY DETAILS

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Notice Details Party A: Banque AIG, London Branch Address: {circle} Facsimile No.: {circle} Attention: {circle} Party B: Permanent Financing (No. 4) PLC Address: Xxxxxxxxx Xxxxx Xxxxxxxxx Xxxx Xxxxxx XX0X 0XX Facsimile Number: 020 7566 0975 Attention: The Secretary With a copy to: (i) the Security Trustee:

  • Contact details 9.1. Any notice, demand, offer or other written instrument required or permitted to be given pursuant to this Standard Transmission Agreement and to the Access Code for Transmission shall be sent to the contact persons mentioned in the contact details sheet as published on the Fluxys Belgium website. The duly filled contact details sheet will be added to attachment 1 of this Agreement. 9.2. Each Party may change these contact detail to which notice shall be sent, or specify one additional address to which copies of notices shall be sent, in accordance with the provisions of this Standard Transmission Agreement.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Technology Research Analyst Job# 1810 General Characteristics

  • TECHNICAL EVALUATION (a) Detailed technical evaluation shall be carried out by Purchase Committee pursuant to conditions in the tender document to determine the substantial responsiveness of each tender. For this clause, the substantially responsive bid is one that conforms to all the eligibility and terms and condition of the tender without any material deviation. The Institute’s determination of bid’s responsiveness is to be based on the contents of the bid itself without recourse to extrinsic evidence. The Institute shall evaluate the technical bids also to determine whether they are complete, whether required sureties have been furnished, whether the documents have been properly signed and whether the bids are in order. (b) The technical evaluation committee may call the responsive bidders for discussion or presentation to facilitate and assess their understanding of the scope of work and its execution. However, the committee shall have sole discretion to call for discussion / presentation. (c) Financial bids of only those bidders who qualify the technical criteria will be opened provided all other requirements are fulfilled. (d) AIIMS Jodhpur shall have right to accept or reject any or all tenders without assigning any reasons thereof.

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