PPT-Capturing and Reporting Adverse Events in Clinical Research

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 . 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. Holden Comprehensive Cancer Center. Protocol Development and Monitoring . Key definitions. Identifying, documenting and reporting Adverse Events. Investigator Responsibilities . How are research participants protected? . 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 . 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. 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. 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? . 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, .