PPT-CURRENT ADVERSE EVENTS REPORTING

IN HEMOPHILIA Alfonso Iorio McMaster University Canada Chair Data and Demographics Committee WFH Chair Canadian Bleeding Disorders Registry PI Canadian Hemophilia Surveillance Scheme. Zarif Jabbar-Lopez, MBBS, MPH. FY2, East of England Deanery. Visiting Research Fellow, Uppsala Monitoring Centre. Disclosure. No conflicts of interest. The . research leading to these results was conducted as part of the PROTECT consortium (. , 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. Reporting Requirements. Protocol References. Section. Title. 7.2. Safety-Related. Data Collection. 7.3. Expedited Adverse Event Reporting. Other References and Resources. 3. Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0). 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. Holden Comprehensive Cancer Center. Protocol Development and Monitoring . Key definitions. Identifying, documenting and reporting Adverse Events. Investigator Responsibilities . How are research participants protected? . Acknowledgement. Acknowledgment to . Ms. Chun Geok Ying . for preparation of the core contents of this presentation. Outline. Why is safety practices important?. What is safety monitoring? . Safety Reporting. Clinical and Institutional Disclosure of Adverse Events to Patients Call 1 of 2 Delivered May 21, 2012 updated to reflect directive’s reissue (October 31, 2018) Sponsoring Offices: National Center for Ethics in Health Care 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 Educational Support for Mandatory Reporting. Module 1: . Overview of Vanessa’s Law . and Reporting Requirements. Educational Support for Mandatory Reporting. The educational materials provide core content about serious adverse drug reaction (serious ADR) and medical device incident (MDI) reporting that . Vaccinia (Smallpox) Vaccine Related Adverse Reaction ��VacciniaRelated Adverse Events ProtocolLast Revised: 3/25/2022Dilated cardiomyopathy and cardiac ischemia are sequelae of viral myo �� &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.44;i 3;.73; 8;.68;– 4; .76;& ];&#x/Sub;&#xtype;&#x /Fo;&#xoter;&#x /Ty;&#xpe /;&#xPagi;&#xnati : Overview for Healthcare Providers Page 1 of 2 V DH/OEPI/DSI Febr uary 2019 Virginia Department of Health Vaccinia Disease and Vaccinia Adverse Events : Overview for Healthcare Providers Organism Updating a Cancer Research Standard. . Ann . Setser. 1. , Ranjana Srivastava. 2. , Lawrence Wright. 1. , Sherri de Coronado. 1. , Alice Chen. 3. . 1. . NCI Center for Biomedical Informatics and Information Technology (CBIIT) . EVENTS AND COMPLETING THE REPORT FORM. Trial protocol code: ISRCTN30952488. Version 2. , . 21 Nov 2017. USE THIS . PRESENTATION . WITH. :. The Trial Protocol (. Section 2.9). . and . G. uidance. . for investigators: .