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. . 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. , 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. The Need to Understand and Incorporate Variation in Impact in Seeking to Influence Outcomes . for Women and Children. Kate Schwartz & . Yeshim. Iqbal. Outline. Impact Evaluations (scale/cost) . 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. 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? . 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. 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. 2019 Spring. SAFETY of the SUBJECT. Safety of the Subject. Key definitions. Identifying, documenting and reporting. Investigator reporting responsibilities . How are research participants protected? . When to generalize and when not to. Rachel . Glennerster. J-PAL and IGC. London School of Economics, June 3, 2014. The challenge. Policy makers often need to make decisions without the luxury of all the evidence they might want. 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. Authors: . 1. Juliet Jokwiro, . 1. Nicole Chekudambune-Kawaza, . 1. Kenny Sithole, . 1. Bongani Dube, . 2. Charles Sandy, . 2. Manners Ncube, . 2 . Regina Mubau,. 2. Chlorata Gwanzura, . 2. Kwenziweyinkosi Ndlovu, .