PPT-Adverse Drug Events Howard Shaps, MD, MBA

Medical Director Health Care Excel February 27 2013 Overview 2 Definitions Statistics and Facts Prevention and Detection Electronic Health Records and Meaningful Use Medication Reconciliation. 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 (. 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. What is an ADR?. What is an ADE?. Adverse Drug Reaction (ADR). any undesirable or noxious drug effect at standard drug treatment doses. WHO;1996 Technical Report Series No. 425. Adverse Drug Event (ADE). 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 . 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.”. Holden Comprehensive Cancer Center. Protocol Development and Monitoring . Key definitions. Identifying, documenting and reporting Adverse Events. Investigator Responsibilities . How are research participants protected? . Medical Director. Health Care Excel. February 27, 2013. Overview. 2. Definitions. Statistics and Facts. Prevention and Detection. Electronic Health Records and Meaningful Use. Medication Reconciliation. 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. 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 Dermatitis. Diarrhea/colitis . Endocrinopathies. including hyper or hypothyroidism, adrenal insufficiency or diabetes (including diabetic ketoacidosis). Other toxicities including: cardiac, ocular, hematological, myopathies and neurological (including paresis, Guillain-Barré and encephalitis). 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…” . of . Life Among Patients Who Report Adverse Events . while on . Treatment . for . Drug-Resistant . TB in Johannesburg, South Africa.  . Denise Evans, . Tembeka Sineke. , Kate Schnippel, Helena . van .