'Unanticipated problem' presentation slideshows

Marley Thrasher Gerry Peterson

1.18k views • 104 slides

Unanticipated Problems Adverse Events Deviations

Unanticipated Problems Adverse Events Deviations. Outline. Regulations- OHRP and FDA Reporting Criteria Examples of Reportable Events Timelines for Reporting IRB Review of Reportable Events. OHRP Regulations and Guidance. HHS regulations 45 CFR part 46.

338 views • 33 slides

Emerging SACHRP Issues

340 views • 23 slides

Understanding Unanticipated Problems (UPs)

Understanding Unanticipated Problems (UPs). Elizabeth Ness, RN, MS Director, Staff Development Office of the Clinical Director Center for Cancer Research, NCI. Objectives. Define what an unanticipated problem is. Describe 2 examples of an unanticipated problem that is also an adverse event.

331 views • 18 slides

HHS Reporting Requirements and Adverse Events

Michael A. Carome, M.D. Director, Division of Compliance Oversight Office for Human Research Protections. HHS Reporting Requirements and Adverse Events. Title 45 Code of Federal Regulations Part 46 Protection of Human Subjects (Last revised June 18, 1991). Educational Objectives.

310 views • 17 slides

Reporting Unanticipated Problems Involving Risk to Subjects or Others and Adverse Events

Reporting Unanticipated Problems Involving Risk to Subjects or Others and Adverse Events. WFUHS Policy/Procedure Effective Date 6/1/07 Wendy Murray Monitoring and Oversight Specialist Office of Research. Revised WFUHS Policy.

232 views • 14 slides

IRB regulatory determinations

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter . IRB regulatory determinations. IRB determinations. regulatory determinations convened board meeting recorded in minutes

250 views • 12 slides