PPT-Sponsor-Investigator (SI) FDA Inspections

Christiana Provencal MA Quality Assurance Quality Improvement Administrator April 13 2018 Inspection assignments are issued by the FDA Center to the District Office There are two types of inspections. Sponsor Responsibilities . Based on ICH . E6. GCP Guidance (Section. 5). Purpose:. To . provide an overview of Sponsor Responsibilities . to study sites. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site . Investigator-Initiated . v. Sponsor-Initiated Clinical Trials – What are the special contract and administration issues to be aware of?  . NCURA Western Regional Conference April 5, 2011 – Denver, CO. Investigator-Initiated . v. Sponsor-Initiated Clinical Trials – What are the special contract and administration issues to be aware of?  . NCURA Western Regional Conference April 5, 2011 – Denver, CO. Educational Material. Returning . Plain Language Summary . Results. Overview of . P. lain . L. anguage Summary . “Translates” the technical results of clinical trials into easy-to-understand language. WMed HRPP . Investigator Responsibilities for . Clinical Trials Research . Introduction. This comprehensive, educational presentation for Clinical . Trials Research . is a resource tool provided by WMed Homer Stryker M.D. School of Medicine for researchers involved in sponsor- and/or investigator-initiated . Stephen Workman, MPH. September 2016. Thomas Jefferson University. Investigator responsibilities. Sponsor assessment of PI performance . What TJU does well. How PIs can be more impressive to sponsors. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. GCP: . Tips on Clinical Trial Conduct and . Preparing for FDA Inspection . Susan Leibenhaut, M.D.. Office of Scientific Investigations (OSI) . CDER/FDA. February 28, 2019. Good Clinical Practice - GCP. Director of Research Operations. Neurological Clinical Research Institute (NCRI). Massachusetts General Hospital (MGH). Dixie Ecklund, RN, MSN, MBA, CCRC. Director of Operations. Clinical Trials Statistical & Data Management Center. When Negotiating a Clinical Studies Agreement Living Document As of May 21 , 2010 Version 2 .0 Living Document Page 1 of 13 As of May 21, 2010 Introduction Collaboration of academic institutions w 1FDA Bioresearch Monitoring BIMO ChecklistRegulationDocuments Neededone copy for FDA auditor and one copy for logging Actions or Questions Which May Be AskedCompleteInitialsUpon notification of FDA au n and Research or CBER conducting clinical research are also referred to as Good Clinical Practices or regulations for nonclinical laboratories compliance regulations during inspections sure that Derita: . dbran@uthsc.edu. Margaret: . mlynn@uthsc.edu. https://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/. Handout/. Reference sheets:. Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH.