PPT-Year in Review — Clinical Investigators Provide Perspectives on the Most Relevant New

Nontargeted Therapy for Lung Cancer Tuesday January 19 2021 500 PM 600 PM ET Matthew Gubens MD MS Suresh S Ramalingam MD Moderator Neil Love MD Faculty YiR Nontargeted Therapy for Lung Cancer Faculty. fdagovScienceResearchSpecialTopicsRunningClinicalTrialsGuidancesInformationSh eetsandNoticesdefaulthtm US Department of Health and Human Services Food and Drug Administration June 2010 Procedural brPage 2br Contains Nonbinding Recommendations Informa Tips for improving your odds of success. FASRI Roundtable July 2011 . 1. SENIOR EDITOR: John Harry Evans III. EDITORS:. Michael L. Ettredge, University of Kansas. David A. Guenther, University of Oregon. ECU Physicians. Board. Dean. Management Operations Team. Compensation Advisory Committee. Clinical Operations Team. ECUP Strategic . Futures . (Ad Hoc “Think Tank”). Responsibility. Mr. Nielsen. TTGL . N3A2. DD . Mmm. YEAR. Overall . Classification UNCLASSIFIED. Agenda. Navy Publication Hierarchy. Joint, Multi-Service, Allied, Multinational Pubs. Review Authorities. Navy Pub Revision Process. Q What is a literature reviewStated most simply it is an overview of published and unpublished materials which help answer two fundamental questions12What is the current state of knowledge about these NOTE A stay is in effect for partsof subsection VID of this guidance dditional information about this staycan be found inthe Notice of Stay that published in the Federal Registerof October 30 201580 Hopkins . in. telligent . health. care. Human health and disease represent a key synthesis of biology and soul. The human condition is shared among all, regardless of origin, social or economic stratum . http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsan dNotices/default.htm U.S. Department of Health and Human Services Food and Drug Administration Offic Daniel R. LevinsonInspector General January 2009 OEI-05-07-00730 THE FOOD AND DRUG ADMINISTRATION’S OVERSIGHT OF CLINICAL INVESTIGATORS’ FINANCIAL INFORMATION Office of Inspector Gene 1 Resources and Environment The Massachusetts General Hospital (MGH) is consistently ranked as one of the top hospitals in the nation. MGH is known for revolutionizing care and has a long, rich 1 , PHS, and HMS RESOURCES AND ENVIRONMENT The Massachusetts General Hospital has a long, rich, and diverse tradition of excellence in clinical research that continues to expand today. The extensiv Investigator of Record – Definition. “The individual at the CRS responsible for ensuring that a clinical trial is conducted in accordance with the protocol, applicable U.S. federal regulations, in-country regulations and any provisions imposed by the reviewing IRB/EC/other regulatory entity. This person is the signatory for the Form FDA 1572 for studies conducted under an IND or the DAIDS Investigator of Record Form for non-IND studies.” (from DAIDS Protocol Registration Manual, p.8). Jim McCarthy; Rutz. , . Erich; . W. ade Shrader; . E. rich Rutz; . Tom . Novacheck; . Kerr . Graham; . Davids, Jon R. .; . Kay, . Robert; Tim Theologis; Unni Narayanan; Anja . Van . Campenhout. ; Laura Brower; Paul Gross. . course. Course occurs in Feb of Year 4. Course Director – Drs. Nierenberg and Lewis. Course has 47 curricular hours. Course was last reviewed in May 2013. Action Plan from Prior Review. Action .