Study Set-Up Sample Clauses

Study Set-Up. If available, VASCULAR BIOGENICS will provide BIOCLINICA with the final study protocol and subsequent amendments at the start of the study. BIOCLINICA will perform the following services upon commencement of the study: • Preparation and set-up of internal clinical trial and regulatory files • Preparation and set-up of required folders on the BIOCLINICA network • Preparation and set-up of project specific BioPACS™ database BioPACS™ is a custom designed enterprise system that provides image management and workflow, query capabilities, inventory and image archival, site and project management tools to automate and accelerate the process of evaluating images generated during a clinical trial. The BioPACS™ Image Core Laboratory technology system complies with FDA 21 CFR Part 11 requirements and adheres to the industry DICOM standard for compatibility with image viewers and other analysis software. Vascular Biogenics Ltd. Ulcerative Colitis Study BIOCLINICA will provide VASCULAR BIOGENICS with access to the BioPACS™ web portal which will allow VASCULAR BIOGENICS to view study documents, access real time project reports and follow the course of study progression within BIOCLINICA. The Web Portal will be password protected and VASCULAR BIOGENICS will have twenty-four (24) hour access to the site. BIOCLINICA will establish a password protected FTP account for each site. The sites will submit 50% of the data to BIOCLINICA via FTP server.
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Study Set-Up. Figure 6 gives a stylized overview of the difference between a raster-based and vector based approach to flood risk modelling. Risk is defined as the combination of hazard, exposure and vulnerability. Flood hazard maps for the baseline scenario and different RCPs are created using the JRC-LISFLOOD model. In a traditional grid-based flood risk assessment, exposure is derived from a land use raster whereas vulnerability per land cover type is described by damage curves. Risk (usually in terms of expected annual damage) can be calculated by integration over the damage estimates from floods with different return periods (i.e. likelihood of flood occurrence). Such an assessment can be done using a tool like Delft-FIAT1. In the OSdaMage model, the exposure rasters are replaced by the vector dataset of roads, drawn from OpenStreetMap2. To enable a fair methodological comparison with the traditional raster-based approaches, one model run is done where the raster damage curves (Xxxxxxxx et al., 2007, 2017) are translated to a vector representation by multiplication the raster damage (€/m2) by road width (m) to obtain a unit road length damage curve (€/km). This is referred to as the adapted Xxxxxxxx (HZ*) function. However, for this study, also a new set of damage curves is developed, which makes benefit of the additional metadata on road type, lane number, presence of bridges and road lighting.
Study Set-Up. The UK was the lead country for the study, with Sponsorship provided by Tayside Medical Science Centre (TASC), a joint partnership of NHS Tayside and the University of Dundee48. Initial ethical approval for the study was obtained from the East of Scotland Research Ethics Service (reference 11/ES/0016). Patient information leaflets and consent forms were translated (and checked by back translation) as necessary for each country and submissions were then made by each of the other three countries to secure ethical permission at their own sites. Overall management of the trial was provided jointly by the Division of Neuroscience, University of Dundee and the Tayside Clinical Trials Unit (TCTU), a UK Clinical Research Collaboration (UKCRC)-registered clinical trials unit21. Study-specific training was given to lead representatives of all countries at an initial set-up meeting. A training package was developed based on this meeting and then distributed to all researchers working on the study via their site. The design of the project enables the study to be run with some flexibility (e.g. in terms of recruitment strategy and number of participating sites) within each of the four participating countries, whilst remaining within the boundaries of the study protocol. Each country had a lead site which coordinated and supported the other recruiting sites within that country. The study had a total of 27 recruiting sites: 6 in the UK led by the University of Dundee; 1 in Hungary at Vadaskert Hopital, Budapest; 6 in Italy led by the University of Cagliari and 12 in Germany led by the Central institute of Mental Health in Mannheim. To ensure that the data collected from the study are of the highest quality, the ADDUCE study was conducted to standards that are in line with GCP guidelines49. A number of measures were put in place to ensure the data are of highest quality possible and are collected in as consistent a way as possible across all sites. These included a comprehensive training package which included audio and video records of the initial training meeting and needed to be completed by all researchers before they began work on the study. Additionally, training meetings were held in each country for which there is more than one site, to ensure that information was disseminated from the lead sites to their satellite sites, and that there was good communication between sites in each country. Similar levels od communication were maintained throughout the study period...
Study Set-Up 

Related to Study Set-Up

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Equipment Testing and Inspection 2.1.1 The Interconnection Customer shall test and inspect its Small Generating Facility and Interconnection Facilities prior to interconnection. The Interconnection Customer shall notify the NYISO and the Connecting Transmission Owner of such activities no fewer than five Business Days (or as may be agreed to by the Parties) prior to such testing and inspection. Testing and inspection shall occur on a Business Day. The Connecting Transmission Owner may, at its own expense, send qualified personnel to the Small Generating Facility site to inspect the interconnection and observe the testing. The Interconnection Customer shall provide the NYISO and Connecting Transmission Owner a written test report when such testing and inspection is completed. The Small Generating Facility may not commence parallel operations if the NYISO, in consultation with the Connecting Transmission Owner, finds that the Small Generating Facility has not been installed as agreed upon or may not be operated in a safe and reliable manner. 2.1.2 The NYISO and Connecting Transmission Owner shall each provide the Interconnection Customer written acknowledgment that it has received the Interconnection Customer’s written test report. Such written acknowledgment shall not be deemed to be or construed as any representation, assurance, guarantee, or warranty by the NYISO or Connecting Transmission Owner of the safety, durability, suitability, or reliability of the Small Generating Facility or any associated control, protective, and safety devices owned or controlled by the Interconnection Customer or the quality of power produced by the Small Generating Facility.

  • Evaluation Software If the Software is an evaluation version or is provided to You for evaluation purposes, then, unless otherwise approved in writing by an authorized representative of Licensor, Your license to use the Software is limited solely for internal evaluation purposes in non-production use and in accordance with the terms of the evaluation offering under which You received the Software, and expires 90 days from installation (or such other period as may be indicated within the Software). Upon expiration of the evaluation period, You must discontinue use of the Software, return to an original state any actions performed by the Software, and delete the Software entirely from Your system and You may not download the Software again unless approved in writing by an authorized representative of Licensor. The Software may contain an automatic disabling mechanism that prevents its use after a certain period of time. RESTRICTIONS

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Project Closeout a. Participate in final inspection to prepare punch lists for project contractor to correct and/or to complete listed items. Verify that items on punch lists have been completed successfully assist COUNTY Project Manager or designee to determine completion date and coordinate project close out. a. Coordinate the preparation, acceptance and distribution of project closeout documents in accordance with COUNTY Project Manager or designee procedures to clients.

  • Inspection and Verification The Secured Parties and such persons as the Secured Parties may reasonably designate shall have the right to inspect the Collateral, all records related thereto (and to make extracts and copies from such records) and the premises upon which any of the Collateral is located, to discuss the Grantor’s affairs with the officers of the Grantor and its independent accountants and to verify under reasonable procedures the validity, amount, quality, quantity, value, condition and status of, or any other matter relating to, the Collateral, including, in the case of collateral in the possession of any third Person, by contacting any account debtor or third Person possessing such Collateral for the purpose of making such a verification. Out-of-pocket expenses in connection with any inspections by representatives of the Secured Parties shall be (a) the obligations of the Grantor with respect to any inspection after the Secured Parties’ demand payment of the Notes or (b) the obligation of the Secured Parties in any other case.

  • Inspection/Testing In order to assess Supplier’s work quality and/or compliance with this Order, upon reasonable notice by Buyer: (a) all goods, materials and services related to the items purchased hereunder, including, raw materials, components, assemblies, work in process, tools and end products shall be subject to inspection and testing by Buyer, its customer, representative or regulatory authorities at all places, including sites where the goods are made or located or the services are performed, whether at Supplier’s premises or elsewhere; and (b) all of Supplier’s facilities, books and records relating to this Order shall be subject to inspection by Buyer or its designee. If specific Buyer and/or Buyer’s customer tests, inspection and/or witness points are included in this Order, the goods shall not be shipped without an inspector’s release or a written waiver of test/inspection/witness with respect to each such point; however, Buyer shall not be permitted to unreasonably delay shipment; and Supplier shall notify Buyer in writing at least twenty (20) days prior to each of Supplier’s scheduled final and, if applicable, intermediate test/inspection/witness points. Supplier agrees to cooperate with such/audit inspection including, completing and returning questionnaires and making available its knowledgeable representatives. Buyer’s failure to inspect or test goods, materials or services or Buyer’s failure to reject or detect defects by inspection or testing shall not relieve Supplier from its warranty obligations or any of its other obligations or responsibilities under this Order. Supplier agrees to provide small business as well as minority and/or women owned business utilization and demographic data upon request.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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.

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