PPT-Adverse Event Documentation: AE Log and GAE Log CRF Completion

Training Binder pages 269 272 Reportable AEs Report on AE Log CRF All genital genitourinary and reproductive system AEs except Fetal losses All Grade 2 and higher AEs All SAEs All AEs that results in permanent product discontinuation . , 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). 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 . 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). 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 �� &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.44;i 3;.73; 8;.68;– 4; .76;& ];&#x/Sub;&#xtype;&#x /Fo;&#xoter;&#x /Ty;&#xpe /;&#xPagi;&#xnati 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: . The Working Group on Medical Measurements. The 23rd Forum Meeting. Tokyo, Japan. Nov. 23-25, 2016. Jin-. Hai. Yang. Bureau of Standards, Metrology and Inspection. Chinese Taipei. 2. Look Back on 2015’s Presentation. Events. Robert Silbergleit, MD. Adverse Events – . key points. Do not report events EXISTING PRIOR to randomization . (unless there is a change in severity). Report the DIAGNOSIS, not the symptoms:. 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…” .