Study Data and Source Records Sample Clauses

Study Data and Source Records. Service Provider and Investigators shall submit to Sponsor complete and accurate case report forms and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol (collectively “Study Data”) in accordance with the schedules set forth therein. All other information and data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, x-rays, biopsy reports, ultrasound photographs or other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at and be the property of the Service Provider and shall be available for inspection in accordance with Section 7.0. In addition, Service Provider agrees to provide any additional data, access or assistance reasonably requested by Sponsor in connection with the approval or clearance of the Study Drug, in accordance with applicable laws. 6.1 Údaje o studii a zdrojové záznamy. Poskytovatel a zkoušející zadavateli předloží kompletní a správné záznamy subjektű studie a jakékoliv další záznamy, hlášení a údaje, jejichž dodání zadavateli műže být v souladu s časovými harmonogramy stanovenými protokolem vyžadováno na jeho základě (společně dále jen „údaje o studii“). Vyjma údajű o studii zűstanou veškeré další informace a údaje shromážděné či vytvořené na základě protokolu nebo připravené v souvislosti s ním, včetně lékařských záznamű, rentgenových snímkű, zpráv z biopsie, ultrazvukových fotografií nebo jiných diagnostických snímkű a veškerých dalších zdrojű primárních dat uvedených v záznamech subjektű studie (společně dále jen „zdrojové záznamy“), v majetku Poskytovatele a budou k dispozici pro případ inspekce v souladu s odstavcem 7.0. Poskytovatel dále souhlasí s tím, že poskytne jakékoliv dodatečné údaje a přístup či asistenci v přiměřené míře požadovanou zadavatelem v souvislosti se schválením nebo povolením hodnoceného léku, a to v souladu s platnými zákony České republiky.
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Study Data and Source Records. Institution and Investigators shall submit to Sponsor complete and accurate case report forms and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol (collectively “Study Data”) in accordance with the schedules set forth therein. All other information and data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, x-rays, biopsy reports, ultrasound photographs or other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at and be the property of the Institution and shall be available for inspection in accordance with Section 7.0. In addition, Institution agrees to provide any additional data, access or assistance reasonably requested by Sponsor in connection with the approval or clearance of the Study Drug.
Study Data and Source Records. Institution shall submit to Sponsor complete and accurate case report forms and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol (collectively “Study Data”) in accordance with the schedules set forth therein. All other information and data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, x-rays, biopsy reports, ultrasound photographs or other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at and be the property of the Institution and shall be available for inspection in accordance with Section 7.0. In addition, Institution agrees to provide any additional data, access or assistance reasonably requested by Sponsor in connection with the approval or clearance of the Study Drug. 6.1 Údaje zo skúšania a zdrojové z áznamy. Inštitúcia odovzdá zadávateľovi vyplnené a presné záznamové formuláre účastníkov klinického skúšania a všetky ostatné záznamy, správy a údaje, ktoré sa môžu vyžadovať na zaslanie zadávateľovi v súlade s protokolom (spoločne ďalej len „údaje zo skúšania“) a podľa harmonogramov ustanovených v protokole. Všetky ostatné informácie a údaje zhromaždené alebo vytvorené v súlade s protokolom alebo pripravené v súvislosti s protokolom, okrem údajov zo skúšania, vrátane zdravotných záznamov, RTG snímok, záznamov z biopsie, snímok ultrazvuku alebo iných diagnostických snímok, ako aj všetky ostatné zdroje primárnych údajov, ktoré sú podkladom údajov zaznamenaných v záznamových formulároch xxxxxxxxxx xxxxxxxxxx xxxxxxxx (xxxxxxxx xxxxx len „zdrojové záznamy“) zostanú a sú vlastníctvom inštitúcie a budú k dispozícii na nahliadnutie v súlade s článkom 7.0. Inštitúcia sa navyše zaväzuje poskytovať všetky dodatočné údaje, prístup alebo podporu, ktoré bude zadávateľ primerane vyžadovať v súvislosti so schválením alebo povolením skúšaného produktu.

Related to Study Data and Source Records

  • Books, Records and Regulatory Filings (a) The Sub-Adviser agrees to maintain and to preserve for the applicable periods any such records as are required to be maintained by the Sub-Adviser with respect to the Fund by the 1940 Act and rules adopted thereunder, and by any other applicable laws, rules and regulations. The Sub-Adviser further agrees that all records that it maintains for the Fund are the property of the Fund and it will promptly surrender any of such records upon request; provided, however, that the Sub-Adviser may retain copies of such records for the applicable periods they are required by law to be retained, and thereafter shall destroy such records. (b) The Sub-Adviser agrees that it shall furnish to regulatory authorities having the requisite authority any information or reports in connection with its services hereunder that may be requested in order to determine whether the operations of the Fund are being conducted in accordance with applicable laws, rules and regulations. (c) The Sub-Adviser shall make all filings with the SEC required of it pursuant to Section 13 of the 1934 Act with respect to its duties as are set forth herein. The Sub-Adviser also shall make all required filings on Schedule 13D or 13G and Form 13F (as well as other filings triggered by ownership in securities under other applicable laws, rules and regulations) in respect of the Portfolio as may be required of the Fund due to the activities of the Sub-Adviser. The Sub-Adviser shall be the sole filer of Form 13F with respect to the Portfolio of the Fund.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.

  • Contractor’s Records The Contractor shall keep true and accurate accounts, records, books and data which shall correctly reflect the business transacted by the Contractor in accordance with generally accepted accounting principles. These records shall be stored in Orange County for a period of three (3) years after final payment is received from the County. Storage of records in another county will require written approval from the County of Orange assigned Deputy Purchasing Agent.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

  • Client Records 25.2.1 CONTRACTOR shall prepare and maintain accurate and 26 complete records of clients served and dates and type of services provided 27 under the terms of this Agreement in a form acceptable to ADMINISTRATOR.

  • Education Records Educational Records are official records, files and data directly related to a student and maintained by the school or local education agency, including but not limited to, records encompassing all the material kept in the student’s cumulative folder, such as general identifying data, records of attendance and of academic work completed, records of achievement, and results of evaluative tests, health data, disciplinary status, test protocols and individualized education programs. For purposes of this DPA, Education Records are referred to as Student Data. Personally Identifiable Information (PII): The terms “Personally Identifiable Information” or “PII” has the same meaning as that found in U.C.A § 53E-9-301, and includes both direct identifiers (such as a student’s or other family member’s name, address, student number, or biometric number) and indirect identifiers (such as a student’s date of birth, place of birth, or mother’s maiden name). Indirect identifiers that constitute PII also include metadata or other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty. For purposes of this DPA, Personally Identifiable Information shall include the categories of information listed in the definition of Student Data.

  • SERVICE MONITORING, ANALYSES AND ORACLE SOFTWARE 11.1 We continuously monitor the Services to facilitate Oracle’s operation of the Services; to help resolve Your service requests; to detect and address threats to the functionality, security, integrity, and availability of the Services as well as any content, data, or applications in the Services; and to detect and address illegal acts or violations of the Acceptable Use Policy. Oracle monitoring tools do not collect or store any of Your Content residing in the Services, except as needed for such purposes. Oracle does not monitor, and does not address issues with, non-Oracle software provided by You or any of Your Users that is stored in, or run on or through, the Services. Information collected by Oracle monitoring tools (excluding Your Content) may also be used to assist in managing Oracle’s product and service portfolio, to help Oracle address deficiencies in its product and service offerings, and for license management purposes. 11.2 We may (i) compile statistical and other information related to the performance, operation and use of the Services, and (ii) use data from the Services in aggregated form for security and operations management, to create statistical analyses, and for research and development purposes (clauses i and ii are collectively referred to as “Service Analyses”). We may make Service Analyses publicly available; however, Service Analyses will not incorporate Your Content, Personal Data or Confidential Information in a form that could serve to identify You or any individual. We retain all intellectual property rights in Service Analyses. 11.3 We may provide You with the ability to obtain certain Oracle Software (as defined below) for use with the Services. If we provide Oracle Software to You and do not specify separate terms for such software, then such Oracle Software is provided as part of the Services and You have the non-exclusive, worldwide, limited right to use such Oracle Software, subject to the terms of this Agreement and Your order (except for separately licensed elements of the Oracle Software, which separately licensed elements are governed by the applicable separate terms), solely to facilitate Your use of the Services. You may allow Your Users to use the Oracle Software for this purpose, and You are responsible for their compliance with the license terms. Your right to use any Oracle Software will terminate upon the earlier of our notice (by web posting or otherwise) or the end of the Services associated with the Oracle Software. Notwithstanding the foregoing, if Oracle Software is licensed to You under separate terms, then Your use of such software is governed by the separate terms. Your right to use any part of the Oracle Software that is licensed under the separate terms is not restricted in any way by this Agreement.

  • Patient Records Upon termination of this Agreement, the New PC shall retain all patient dental records maintained by the New PC or the MSO in the name of the New PC. During the term of this Agreement, and thereafter, the New PC or its designee shall have reasonable access during normal business hours to the New PC's and the MSO's records, including, but not limited to, records of collections, expenses and disbursements as kept by the MSO in performing the MSO's obligations under this Agreement, and the New PC may copy any or all such records.

  • Contractor Records The Contractor shall make, keep, maintain, and, upon request, provide to the UCRC or its agents or designees a complete file of all materials or records required in Exhibit A, Verification Plan. This provision survives termination of this SCIA until completion of the Pilot Program.

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