Clinical Study. The term “
Clinical Study. The term “Clinical Study” shall mean a Phase I, Phase II, Phase III Study, as applicable.
Clinical Study. Hospital and Investigator agree to use their best efforts and professional expertise to perform the Clinical Study according to the Protocol as set forth in Exhibit A. Hospital agrees to provide such qualified personnel, equipment, materials (except materials to be provided by Sponsor as hereinafter set forth) and facilities as are necessary to perform the Clinical Study. Hospital and Investigator agree to comply with all applicable laws and regulations relating to the use of such equipment, materials and facilities and to the employment of such personnel.
Clinical Study. A research study using human subjects or data from living human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies. 5 xxxx://xxx.xxxx.xxx.xxx.xxx/books/NBK9572/ 6 45 CFR 164.504(e): Uses and disclosures: Organizational requirements: xxxx://xxx.xxxx.xxx/cgi-bin/text- idx?SID=938e08839465e82e2c30c3bd4a359ce2&node=pt45.1.164&rgn=div5%23se45.1.164_1402#se4 5.1.164_1504 8 10 CFR 1045.21 Privately Generated Restricted Data: xxxxx://xxx.xxx.xxx/fdsys/granule/CFR-1999-title10- vol4/CFR-1999-title10-vol4-sec1045-21 9 Executive Order 12958: 32 CFR 701.23 xxxxx://xxx.xxx.xxxxxxx.xxx/cfr/text/32/701.23 10 Classified National Security Information, April 17, 1995: Executive Order 13526 xxxxx://xxx.xxxxxxxxxx.xxx/the-press-office/executive-order-classified-national-security-information 11 Atomic Energy Act of 1954: Nuclear Regulatory Legislation, 109th Congress: Session NUREG-0980 Vol. 1, Mo. 7. Office of the General Counsel, U.S. Nuclear Regulatory Commission: xxxx://xxxxxxx.xxxxxx.xxx/~/media/bes/pdf/nureg_0980_v1_no7_june2005.pdf Code of Federal Regulations (CFR) A codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government in the United States. • 21 CFR Part 50 Protection of Human Subjects12 • 21 CFR Part 54 Financial Disclosure by Clinical Investigators13 • 21 CFR Part 56 Institutional Review Boards14 • 21 CFR Part 312 Investigational New Drug Application15 • 21 CFR Part 314 Applications for FDA Approval to Market an New Drug or an Antibiotic16 • 21 CFR Part 320 Bioavailability and Bioequivalence Requirements17 • 45 CFR Part 46 Protection of Human Subjects (Common Rule)18 Coded Data See Data Classification Common Rule The federal rule that governs most federally funded research conducted on living human subjects and aims to ensure that the rights of human subjects are protected during the course of a research project, historically focusing on protection from physical and mental harm by stressing autonomy and consent.19 Competent Authorities See Regulatory Authorities Confidentiality When referring to a study participant addresses the issue of how personal data that have been collected for one approved person may be held and used by the organization that collected the data, what other secondary or further uses may be made of...
Clinical Study. Through the use of the Principal Investigator and its Study Staff, the Institution shall undertake and complete in a timely fashion the Study within the agreed period for performance in strict accordance with this Agreement, the Protocol (including all amendments hereto) and the budget outlined in Exhibit A hereto (the “Budget”). Institution shall not subcontract any of the services to be performed by it in accordance with the Study, the Protocol, or this Agreement, without the prior written consent of CRO. 1.1
Clinical Study. University and Investigator agree to use their best efforts and professional expertise to perform the Clinical Study according to the Protocol as set forth in Exhibit A. University agrees to provide such qualified personnel, equipment, materials (except materials to be provided by Sponsor as hereinafter set forth) and facilities as are necessary to perform the Clinical Study. University and Investigator agree to comply with all applicable laws and regulations relating to the use of such equipment, materials and facilities and to the employment of such personnel.
Clinical Study. Through the use of the Study Staff, the Site shall undertake and complete in a timely fashion the Study within the agreed period for performance in strict accordance with this Agreement, the Protocol (including all amendments hereto) and the budget outlined in Exhibit A hereto (the “Budget”). Site shall not subcontract any of the services to be performed by it in accordance with the Study, the Protocol, or this Agreement, without the prior written consent of CRO.
Clinical Study. Section 6 of the Co-Participation Agreement is hereby amended to add Section 6.7 as follows:
Clinical Study. A. Within five (5) days and within sixty (60) days after the date of the December 3, 2004 execution of this Agreement, Life Medical shall give one hundred thousand ($100,000) dollars and an additional one hundred thousand ($100,000) dollars, respectively, to Scantek, which funds shall be utilized by Scantek for the completion of a clinical study consisting of at least two hundred (200) patients (the "Clinical Study") by Dr. Virgilio Sacchini ("Dr. Sacchixx") xx xx xxx xxxxxxx or xxxxxxxxxxxxst working with Dr. Sacchini, if Dr. Sacchini is not xxxxxxxxx xor anx xxxxxx.
Clinical Study. A. The Manufacturer is involved in a clinical study consisting of at least two hundred (200) patients (the "Clinical Study") being conducted by Dr. Virgilio Sacchini ("Dr. Sacchinx"), xx xxx xxxxxxx or Xxxxxxxxxxxxst working with Dr. Sacchini. Pursuant
