PDF-Guidance onUnanticipated Problems (UPs) and Adverse Events (AEs)

Bertha deLandaIRB Training SpecialistResearch Compliance OfficeApril 2011 Research Compliance Office AE adverse eventSAE serious adverse eventUP unanticipated problemUnexpected Related Harmful. UPS Internet Shipping on upscom TM 2 UPS CampusShip TM 3 WorldShip TM 4 Quantum View TM Manage 5 Tracking on upscom PROPRIETARY AND CONFIDENTIAL THIS PRESENTATION MAY NOT BE USED OR DISCLOSED TO ANY PERSON OTHER THAN EMPLOYEES OF CUSTOMER UNLESS EXP OBJECTIVES. Describe Adverse Events, Risks and Problems that can Occur in . H. uman . S. ubjects . R. esearch . C. ompliance with Safety . R. eporting . R. egulations in Clinical Research. Identify Current Systems of Patient Care and Patient Safety in Research. . Which Form 4 to Use?. Reason for Reporting Unanticipated Problems. “to assure the protection of the rights and welfare of the human subjects”. UTHSC IRB Submission Forms. 4a: Reportable local adverse events. , Unanticipated . Problems, and Protocol Deviations. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. 1. Learning Objectives: Adverse Events. S. Percy Ivy, MD. Associate Chief, Senior Investigator. Investigational Drug Branch, National Cancer Institute. ivyp@ctep.nci.nih.gov. . National Cancer Institute. . . Cancer Therapy Evaluation Program (CTEP). 15. th. FERCAP International Conference. 24 Nov 15. Nagasaki, Japan . Bussara Sukpanichnant, CIP. USAMD-AFRIMS. 1. Why I need to know about Unanticipated Problems?. Unanticipated Problem Involving Risks . Force, motion, and energy are observed in living systems and the environment in several ways. . Catastrophic events of weather systems such as hurricanes, floods, and tornadoes can. . shape and restructure the environment through the force and motion evident in them. . Tricep. Dips (4). Shoulder press (5). Bicep Curl. (6). Skipping. (2). Step ups. (7). Equipment . Bench . Stop watch . Skipping Rope. Step up box. Reasonable weights for the age. group . White board pens. S. Percy Ivy, MD. Associate Chief, Senior Investigator. Investigational Drug Branch, National Cancer Institute. ivyp@ctep.nci.nih.gov. . National Cancer Institute. . National Cancer Institute. Rachel Phillips & Victoria Cornelius. Review. “recommended improvements in the accuracy of harm data in RCT reports and a need to standardize practices for reporting.”. Review. “found that methods used to collect adverse event data, the frequency of collection, and the selection criteria used by authors for reporting adverse events vary substantially, and these events are often inadequately reported.”. . Presentation Overview. PSRT queries. Safety Physicians. Adverse Events. PSRT Query Process. <. 72 . hours. Email to . (. mtn028safetymd@mtnstopshiv.org. ) . Your Protocol Safety Physicians. Devika Singh. MODULE 3 Adverse events following immunizationOverviewUnder recommended conditions all vaccines used in national immunization programmes are safe and e31ective if used correctly In practice however no Investigator Kick-off Meeting. January 30-31, Clearwater, Florida. Jodie Riley, MISM and Robert Silbergleit. Adverse Events. Adverse Events (AEs) are “. . . any . untoward. medical occurrence in a subject that was not previously identified which does not necessarily have a causal relationship to the study drug…” . of . Life Among Patients Who Report Adverse Events . while on . Treatment . for . Drug-Resistant . TB in Johannesburg, South Africa.  . Denise Evans, . Tembeka Sineke. , Kate Schnippel, Helena . van .