PPT-Tool: Training Presentation: Investigator Responsibilities and Good Clinical Practice

Based on ICH E6 GCP Guidance Sections124 amp 6 and 45 CFR 46 Protection of Human Subjects Purpose To provide an overview of Investigator Responsibilities and GCP to study sites. Training Presentation: Investigator Responsibilities and Good Clinical Practice (GCP). Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM). Presented By :. Version: 1.0/2017. 1. Good clinical Practices. Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. . . . Trainee:. . . . Name. Trainer:. Mr. . Jean-Paul Eycken. CEO . FormaliS. SA. This ICH . E6(R2) . GCP Investigator Site Training meets . the Minimum Criteria for . 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. Investigator Safety. Instructor Name. Agency. Session Introduction. Learning Objectives. Upon completion of the session, you will be able to: . Describe security and safety concerns faced by investigative staff and ways they may be reduced.. December 14, 2016. 11:00 am. IOP Auditorium. Topics Covered. MUSC Health MyChart Use in Research. Recent Notices (NIH and NSF). NIH’s GCP Training Requirement for Clinical Trials. Updates, Reminders & Other Announcements. 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. 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 Anne Roussell, RN. [adapted from . MAGI/. Complion. Presentation . by Velma . Marzinotto. , RN. April 2018]. 1. References. ICH. . E6 (R2): . Good. . Clini. c. al. P. r. ac. t. i. c. es. . (. G. Purpose:. To . provide an overview of the . key roles and responsibilities of investigators and staff engaged in NIDCR-funded research. . Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators. . Global Cooling Prize (GCP). . was launched on 12. th. November, 2018 by Hon’ble Union Minister for Science & Technology and Earth Sciences and Environment, Forest & Climate . Change. .. 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 sheet:. ICH GCP Principles.