PPT-Lessons to learn from the reporting of adverse events in RCTs published in four high impact

Rachel Phillips amp 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. 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. Goal for “Raising the Bar” for RCT. Enhance consistency and quality of care delivery. Craik RL, Maher C. Still “Not Satisfied”…Yet. . Phys . Ther. . 2008;88:423-425.. PTJ History for RCT Standards. Sergio . Leonardi. , L. Kristin Newby, E. Magnus . Ohman. , Paul W. Armstrong.. November 16. th. 2010. . Chicago, IL – AHA Scientific Sessions. Disclosures Information. None of the authors have relevant financial disclosures. Graeme MacLennan. James Lind. Born Edinburgh 1716. On HMS Salisbury in 1747 he allocated 12 men with scurvy. Cider. Seawater. Horseradish, mustard, garlic. Nutmeg. Elixir Vitriol . Oranges and Limes . , 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. Rupinder Dhaliwal, RD. Daren . Heyland. , MD. Guidelines for Nutrition Therapy in the ICU. Rupinder Dhaliwal, RD. Operations Manager. Clinical Evaluation Research Unit. Kingston, Ontario. Disclosure. 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). 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 . 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? . Surgeons’ lack of understanding of levels of evidence and trial methodology is a major barrier to RCTs in breast surgery. G. Davies , N. Mills, C. Holcombe, S. Potter Background What is the problem? 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…” .