PPT-SAFETY PRACTICES AND REPORTING IN CLINICAL RESEARCH

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. 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 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. . Why are we doing this?. . Reporting Period . Q1 13/14 – 01/07/2012 . to . 30/06/2013. Through . the NIHR (National Institute for Health Research) th. e . Government wishes to see a dramatic and sustained improvement in . Practices. GCA Practices. – Bruce Guthrie, GCA. Institution Practices – David De Bellis, Flinders University. DEEWR Practices – Phil Aungles, DEEWR. Good Universities Guide Practices – Ross White, Hobsons. 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 . into the World of Interactive Dashboards and . Visualizations. State Reporting. Cortni Haralson. . Manager, Texas State Reporting. Analytics and Institutional . . Reporting. Outline. Introduction. 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 . 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 . MBA. Director, Investigator Support & Integration Services, OCTRI. January 26, 2011. Journal of Clinical Research Best Practices. Vol. . 7, No. 1, January 2011 . “. Can You Handle the Truth. Leader in Patient Safety or . Apologist for the Status Quo. Outline of Presentation. Mcare. Law of 2002. Formation of the Patient Safety Authority (PSA). Development of PA Patient Safety Reporting System. Office of Human Subjects Research Institutional Review Board (IRB) Open House. Frederick W. Luthardt, DBE, MA. Manager, OHSR Compliance Monitoring Program. Suzanna Roettger, MA. Senior Compliance Monitoring Specialist. Provincial Quality Assurance workshops. Quality Assurance. COO’s Office. Ronel Steinh. öbel. Contents. Background. Purpose . Legal and policy framework. Scope . Definitions. Mandatory requirements. Doug Altman. Centre for Statistics in Medicine, Oxford, UK. and EQUATOR Network . The EQUATOR workshop, October 2012. , Freiburg. The impact of a research article. Scientific manuscripts should present sufficient data so that the reader can fully evaluate the information and reach his or her own conclusions about results . Kondalkar Avinash, Sharma Rahul, Patle Shiker, and Srivastava Rajnish. Objective:. . The . present study was to estimate extend or percentage of Adverse Drug Reaction (ADR) reporting in Bhopal region at pilot level. Our main objective is not only to find out the reporting status but is to find out the possible causable reason behind the under-reporting of the suspected ADRs by the private practioners.