PPT-Remote Monitoring of Adverse Events

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 31232 Adverse Events An adverse event or suspected adverse reaction is considered serious if in the view 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. Data Safety Monitoring and Reporting . requirements. Brown Bag Series: Noon / First Tuesday of the Month. April 4. th. , 2017 - . Auditorium . B. Updates. . AAHRPP update. New initiatives: . Improving the . 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.”. 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. Data Safety Monitoring and Reporting . requirements. Brown Bag Series: Noon / First Tuesday of the Month. April 4. th. , 2017 - . Auditorium . B. Updates. . AAHRPP update. New initiatives: . Improving the . What is . postmarket. monitoring?. Why is it important?. Tools used in . postmarket. monitoring. Managing risk. Adverse events. Risk management plans. Signals. Early warning system. Recall. actions. 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 Henry Lee, MD. Office of Health Technology 4: Surgical and Infection Control Devices. Office of Product Evaluation and Quality. Center for Devices and Radiological Health. U.S. Food and Drug Administration. 2019 Spring. SAFETY of the SUBJECT. Safety of the Subject. Key definitions. Identifying, documenting and reporting. Investigator reporting responsibilities . How are research participants protected? . 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 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…” .