PDF-Safety Information and Unanticipated Problems Reporting

Objectives This presentation will address the following issues 149What events must be promptly reported to the Quorum Review institutional review board 149When and how such events must be repor. difficile LabID Event FacWideIN January 2013 Healthcare Personnel Influenza Vaccination All Inpatient Healthcare Personnel January 2013 Medicare Beneficiary Number All Medicare Patients Reported into NHSN July 2014 CLABSI Adult Pediatric Medical Su 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. This guidance represents OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word should in OHRP guidance An EPSC view on the use of lagging indicators in reporting process safety performance. June 2010. Process Safety Performance. EPSC encourages the use of performance indicators in process safety amongst member and non-member companies. The use of appropriate metrics serving both internal company and industry-wide needs will stimulate learning, identify opportunities for improvements and facilitate communication on achievements.. Reporting: . Who, What, When, and Why. February, 2012. CASE #1- A Serious Adverse Event. The Background:. A PI became aware of a local unanticipated serious adverse event on January 1, 2012. It was not reported to the IRB by the PI until January 25, 2012, as part of a continuing review submission. . Injury Reporting. COMMON EXCUSES FOR NOT REPORTING AN INJURY:. “It was just a little scrape, it really wasn’t worth reporting”. “I was just so busy I forgot”. “It didn’t seem like a big deal at the time”. Melody Lin, Ph.D.. December,12. 2012. Unanticipated problems involving risk to participants or others. Is . unexpected . Is . related or possibly related . to participation in the research, and. Indicates that subjects or others are at a . , 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. 15. th. FERCAP International Conference. 24 Nov 15. Nagasaki, Japan . Bussara Sukpanichnant, CIP. USAMD-AFRIMS. 1. Why I need to know about Unanticipated Problems?. Unanticipated Problem Involving Risks . The purpose of this site is to provide safety-related information to all employees. The on-line Safety Data Sheet (. SDS. ) system is accessed from the Safety SharePoint site. Safety Management System. Adapted from the FAD . PReP. /NAHEMS . Guidelines: Health and Safety (2011). Incident. Accident, illness, suspected/actual case of exposure. Personnel should:. Immediately notify supervisor. Report incidents via phone to SHEPB . 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. Human Research Protection Program (HRPP). HRPP COMPLIANCE AND QUALITY TEAM . Yale University. . Federal regulations (45 CFR 46 & 21 CFR 56) require institutions to establish written procedures for ensuring prompt reporting of any unanticipated problems involving risks to subjects or others (UPIRSOs) to the IRB, appropriate institutional officials, and the federal department or agency head..