PPT-Sponsor Expectations for Clinical Studies

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. Introduce precise claims distinguish the c laims from alternate or opposing claims and create an organization that establishes clear relationships among the claims counterclaims reasons and evidence b Develop claims and counterclaims fairly supplyin 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 . Perspectives. Accelerating . Anticancer Agent Development and Validation . Workshop. May 7, 2015. Elizabeth Garrett-Mayer, PhD. Professor of Biostatistics. Hollings Cancer Center, Charleston, SC. Disclosure Information. bottlenecks. Matt Cooper. Business . Development & Marketing Director . NIHR Clinical Research Network. matt.cooper@nihr.ac.uk. Supporting the life-sciences industry in UK clinical research delivery. Staff number grew from 1 to . 500+. 15+ Years of Strong Growth. 2004. 2008. 2014. 2015. 2001. 2015. 2012. Company Founded by Dr. Song Li . Opened Shanghai, China office. Began Phase I Clinical Operations . Community Rehabilitation and Disability Studies. University of Calgary, . . Second . Annual Conference on Governance of . Emerging . Technologies: Law, Policy, and . Ethics, . USA, May 26-29, 2014 . 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. . Professional Development Series . July 25, 2016. Hey, Sisyphus, when you get a minute, I’d like to discuss the new social studies standards with you.” . Understand the genesis of the 2016 Social Studies expectations.. Standard Terms and Conditions . Cara Martinoli. Clinical Research Attorney, Clinical Trial Office. Tara Keating, J.D.. Agreement Associate, Clinical Trial Office/Grants & Contracts. January 2018. 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 Faculty of Nursing. University of Alberta. Dr. Dianne . Tapp. Associate Dean Graduate Studies. Tracy Quigley. Graduate Administrator. AGENDA. Are you interested in pursuing Nurse Practitioner studies?. Once a lead molecule (candidate compound) is identified, non-clinical development begins. Non-clinical studies seek to answer the following questions:. Does it work? (. E. fficacy assessment). How can it be delivered and how does the body react? . 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. Historical. Results. Karen . Manion. Sally Mountcastle. 1. Office for Clinical Research (OCR). Background. Currently the OCR is divided into two teams. Team 2 is responsible for . Winship. Cancer Institute and Radiation Oncology clinical trials. Team 1 is responsible for studies not involving cancer..