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. 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. . Research Services. University of Oxford. Range of CTRG remit. Sponsorship. Compliance oversight – initial and ongoing. Advice and support. Templates and Standard Operating Procedures. Good Clinical Practice Training . 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 . September 2016. EPYQ and . TIDieR. — Health Research Reporting Guidelines —. Steffany. . Haaz. . Moonzs. PhD. Marland. University of Integrative Health. smoonaz@muih.edu. David Riley MD. Portland, Oregon. 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. 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. 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 . Volume 35 Number 8Ssical characteristics that de31ne drugs as candidates for blood concentration monitoring long-term therapy high interindividual but toxicity with rather narrow therapeutic index rev Marianne Kearney. Director of Research Operations Neurological Clinical Research Institute. Massachusetts General Hospital. Goals of successful collaboration in multicenter clinical trials. Efficient implementation of the trial across multiple clinical sites. 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?. Best Practices and Enhanced Standards for Research. “International norms, standards, and guidelines … are required to govern, manage and improve the quality of research; address inefficiencies…; promote transparency (related to planned, ongoing, . Developing a Culture of Safety in Biomedical Research. 2. Do You Know the Name Sheri . Sangji. ?. https://. cen.acs.org. /safety/lab-safety/10-years-Sheri-Sangjis-death/97/i1. 3. Sheri . Sangji’s. Death Led to Criminal Charges against the PI and UCLA and to the Formation of the UC Center for Laboratory Safety. Doug . Altman. The EQUATOR Network. Centre for Statistics in Medicine, Oxford, UK. Transparency and value. Research only has value if . Study methods have validity. Research findings are published in a usable form .