Záznamy subjektů observační studie Sample Clauses

Záznamy subjektů observační studie. Za všechny subjekty zařazené do observační studie bude poskytovatel nebo zkoušející vyplňovat a společnosti Agios nebo jejímu zástupci poskytovat všechny záznamy subjektů observační studie (case report forms, CRF) na xxxxxxxxxxx xxxxxxxx xxxxxxxxxxx Xxxxx, xxx jsou k observační studii zapotřebí, ve všech ohledech v souladu s protokolem. Na požadavek společnosti Agios nebo jejích zástupců opraví poskytovatel nebo zkoušející ve formulářích neprodleně všechny případné chyby nebo opomenutí a opravené formuláře zpřístupní společnosti Agios nebo jejím zástupcům společně s podkladovými záznamy pro další ověřování. 4.3
AutoNDA by SimpleDocs

Related to Záznamy subjektů observační studie

  • 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.

  • 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.

  • Geological and Archeological Specimens If, during the execution of the Work, the Contractor, any Subcontractor, or any servant, employee, or agent of either should uncover any valuable material or materials, such as, but not limited to, treasure trove, geological specimens, archival material, archeological specimens, or ore, the Contractor acknowledges that title to the foregoing is vested in the Owner. The Contractor shall notify the Owner upon the discovery of any of the foregoing, shall take reasonable steps to safeguard it, and seek further instruction from the Design Professional. Any additional cost incurred by the Contractor shall be addressed under the provision for changed conditions. The Contractor agrees that the Geological and Water Resources Division and the Historic Preservation Division of the Georgia Department of Natural Resources may inspect the Work at reasonable times.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Vientisäätely Sitoudut siihen, ettei Apple-ohjelmistoa viedä edelleen suorasti eikä epäsuorasti ulkomaille, ellei tähän ole erikseen annettu lupaa Yhdysvaltain tai sen oikeustoimialueen/niiden oikeustoimialueiden laeissa, jo(i)sta Apple-ohjelmisto on hankittu. Erityisesti Apple-ohjelmistoa ei saa viedä suorasti tai epäsuorasti (a) Yhdysvaltojen vientikiellossa olevaan maahan tai (b) kenellekään U.S. Treasury Departmentin Specially Designated Nationals -luettelossa olevalle tai U.S. Department of Commercen Denied Person’s List- tai Entity List -luetteloissa tai missään muissa rajoitusten alaisten osapuolten luetteloissa olevalle. Apple-ohjelmistoa käyttämällä annat takuun siitä, ettet ole missään tällaisessa maassa tai luettelossa. Takaat myös, että et käytä Apple-ohjelmistoa mihinkään sellaiseen tarkoitukseen, joka on kielletty Yhdysvaltain laissa, mukaan lukien (mutta näihin rajoittumatta) ohjusten, ydinaseiden tai kemiallisten tai biologisten aseiden kehitys, suunnittelu, valmistus tai tuotanto.

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • First sampling In the first sampling four lamps are selected at random. The first sample of two is marked A, the second sample of two is marked B.

  • Research Project 3.1 These Materials and Data will be used by Recipient's PI solely in connection with the Research Project, as named and described in the attached research application (insert Research Project name below):

  • Dienste Und Materialien Von Drittanbietern (a) Die Apple-Software gewährt möglicherweise Zugang zu(m) iTunes Store, App Store, Apple Books, Game Center, iCloud, Karten von Apple und zu anderen Diensten und Websites von Apple und Drittanbietern (gemeinsam und einzeln als „Dienste“ bezeichnet). Solche Dienste sind möglicherweise nicht in xxxxx Sprachen oder in xxxxx Ländern verfügbar. Die Nutzung dieser Dienste erfordert Internetzugriff und die Nutzung bestimmter Dienste erfordert möglicherweise eine Apple-ID, setzt möglicherweise dein Einverständnis mit zusätzlichen Servicebedingungen voraus und unterliegt unter Umständen zusätzlichen Gebühren. Indem du diese Software zusammen mit einer Apple-ID oder einem anderen Apple-Dienst verwendest, erklärst du dein Einverständnis mit den anwendbaren Servicebedingungen für diesen Dienst, z. B. den neuesten Apple Media Services-Bedingungen für das Land, in dem du auf diese Services zugreifst, die du über die Webseite xxxxx://xxx.xxxxx.xxx/legal/ internet-services/itunes/ anzeigen und nachlesen kannst

Time is Money Join Law Insider Premium to draft better contracts faster.