Clinical Study Site File Dokumentace Sample Clauses

Clinical Study Site File Dokumentace týkající se klinického hodnocení prováděného na pracovišti 3.3.1 Creation of Clinical Study Site File Vytvoření dokumentace týkající se klinického hodnocení prováděného na pracovišti 3.3.1.1 Before commencement of the Study, the Investigator, with the assistance of ICON, shall set up a file, which shall include the documents below (hereinafter called the “Clinical Study Site File”) a copy of which initial Clinical Study Site File shall be promptly sent to ICON: Před zahájením klinického hodnocení zkoušející ve spolupráci se společností ICON vytvoří dokumentaci, která bude zahrnovat níže uvedené dokumenty (dále jen „dokumentace týkající se klinického hodnocení prováděného na pracovišti“). Kopie základní dokumentace týkající se klinického hodnocení prováděného na pracovišti bude neprodleně zaslána společnosti ICON: A) A list of the names, titles and occupations of each member of the IEC; and A) Seznam jmen, titulů a povolání každého člena NEK B) Written IEC/SÚKL approval of the Protocol and evidence of any other approvals required at Institution to conduct the Study; and B) Písemné schválení protokolu ze strany NEK a SÚKL a dokladů o jakýchkoli dalších schváleních, která jsou ve zdravotnickém zařízení vyžadována pro provedení klinického hodnocení C) The IEC/SÚKL approved Informed Consent Form; and C) Formulář informovaného souhlasu schválený ze strany NEK a SÚKL D) The current curriculum vitae of the Investigator and all other Site personnel listed performing a Study- related function; and D) Aktuální životopis zkoušejícího a všech dalších zaměstnanců Pracoviště, kteří vykonávají jakoukoli funkci související s klinickým hodnocením E) The financial disclosure documentation as defined in Section 5.5 below. E) Dokumentace týkající se finanční a majetkové nezávislosti, která je definována v článku 5.5 níže F) Permission of SÚKL or notification on announcement made to SÚKL F) Schválení SÚKL nebo ohlášení klinického hodnocení zaslané na SÚKL G) Other documents and information according to Regulations, particularly in compliance with Act No.378/2007 Coll., as amended, and its enclosures. G) Další dokumenty a informace v souladu s právními předpisy, zvláště zákonem č. 378/2007 Sb., o léčivech, ve znění pozdějších předpisů, a jejich přílohy. 3.3.2 Maintenance of the Clinical Study Site File Vedení dokumentace týkající se klinického hodnocení prováděného na pracovišti 3.3.2.1 During the Study, the Investigator shall in accordance with the terms of this Agreement, main...
Sample 1See All (9)
AutoNDA by SimpleDocs

Related to Clinical Study Site File Dokumentace

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!