PPT-Adverse Events Following Immunization

AEFI Adverse Events Following Immunization AEFI The goal of immunization is to protect individuals from specific disease but may lead to adverse events that require careful monitoring. phacaspcgccaimae57375formengphp Report events which have a temporal association with a vaccine and which cannot be clearly attributed to other causes A causal relationship does not need to be proven and submitting a report does not imply causality Of 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. . National Cancer Institute. Dee Blumberg, PhD. An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . (21 CFR 312.32).. Adverse Events. An adverse event or suspected adverse reaction is considered “serious” if, in the view of . 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.”. 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. What do I do now?. Identifying and Reporting . Adverse Events and Protocol Deviations. Elizabeth Mathis, CCRP. 18 February 2014. Overview and Objectives. http://www.hhs.gov/ohrp/policy/advevntguid.html. 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 655 West 12th AvenueVancouver BC V5Z 4R4Tel 6047072548Fax 6047072515wwwbccdccaCommunicable Disease Control ManualChapter 2 Immunization PartAdverse Events Following ImmunizationCommunicable Disease C 1 Paper AB02 Adverse Event Analysis - One step forward! Anuja Rasal , Syneos Health, Pune , India ABSTRACT From Headache (mild AE) to a Cardiac Arrest (severe AE); every adverse event in a clinic 112/16/2020 CS321570-H Purpose Sex and Weight of PatientNeedle GaugeNeedle LengthInjection SiteFemale or male fewer than 130 lbsDeltoid muscle of armFemale or male 130Deltoid muscle of armFemale 152 Reporting and Management. Dr Vikas Madaan,. Senior Programme Manager. AEFI Secretariat, ITSU. Basics of AEFI surveillance. Definition. Types and categories of AEFI. AEFI organization. Reporting and Timeliness. 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…” .