PDF-Adverse Event Reporting for Outsourcing FacilitiesUnderSection 503B of

x0000x0000 xAttxachexd xBottxom xBBoxx 6x644x69 3x573x08 8x568x96 4x976x26 xSubxtypex Foxoterx Tyxpe xPagixnati. , 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. placebo. REPORTING ADVERSE EVENTS AND COMPLETING THE REPORT FORM. Trial protocol code: ISRCTN30952488. Version 1, 17 November 2016. THIS PRESENTATION MUST BE USED WITH:. The Trial Protocol (. Section 2.9). Adverse Event . 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). 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. 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. 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. 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. 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. Version 04 . Feb. 2021. In . this. . training course you will learn. What. is . pharmacovigilance. ?. What is the pharmacovigilance responsibility of the investigator in a clinical trial?. What is the pharmacovigilance responsibility of the sponsor in a clinical trial?. 2019 Spring. SAFETY of the SUBJECT. Safety of the Subject. Key definitions. Identifying, documenting and reporting. Investigator reporting responsibilities . How are research participants protected? . First Codification History Date New Codification November 2005 E2A Approval by the Steering Committee under 24 June 1993 E2A Current Step 4 version E2A Approval by the Steering Committee u 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: .