'Unanticipated problems' diaporamas de présentation

Reportable Events and Incidents Training SOP KP-502

Reportable Events and Incidents Training SOP KP-502. Research Compliance Training. 2012. KPSC Version 2 Dated 8/15/2012. Required Training. The training takes approximately 1 hour. All Research Team Members who contribute to the conduct of research must complete the training, including:

1.06k views • 77 slides

Roy R. Estrada, PhD, PA-C, CIP Associate Director IRB UTHSCSA

Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO). Roy R. Estrada, PhD, PA-C, CIP Associate Director IRB UTHSCSA. What?. The UTHSCSA Institutional Review Board (IRB) applies an Adverse Events reporting process based on federal guidance

642 views • 50 slides

Human Subjects Protection: Creation and Maintenance of an IRB

Human Subjects Protection: Creation and Maintenance of an IRB. Regulatory Requirements & Recommendations 45 CFR part 46 Freda E. Yoder Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) March 30, 2005 NARCH Researchers - PI & PD Meeting

485 views • 39 slides

Culture change - overview

Culture change - overview. Culture is always changing. Discoveries and inventions do not necessarily lead to change Diffusion is the source of innovations Direct contact, intermediaries, and stimulus diffusion, revolution Acculturation in the context of superordinate and subordinate relations

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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.

336 views • 33 slides

Unanticipated Problems Potentially Involving Risks to Subjects or Others

Unanticipated Problems Potentially Involving Risks to Subjects or Others. Research Protections Office Serving UVM and FAHC Updated April 2012. Unanticipated Problems (UAPs).

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Adverse Events, Unanticipated Problems, Protocol Deviations & other Safety Information

456 views • 19 slides

Noncompliance in Clinical Research Settings & Protecting Participants

Noncompliance in Clinical Research Settings & Protecting Participants. Lisa Buchanan, MAOM Division of Compliance Oversight. What is the Office for Human Research Protections (OHRP)?.

202 views • 19 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.

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SERIOUS ADVERSE EVENTS REPORTING

SERIOUS ADVERSE EVENTS REPORTING. Elizabeth Dayag IRB Administrator Naval Medical Center Portsmouth. Overview. Important definitions Review key features of the NMCP Serious Adverse Events (SAE) Reporting Policy Questions and discussion. What is an Adverse Event (AE)?.

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Office of Research Oversight

246 views • 16 slides

Office of Research Oversight

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What is a Data and Safety Monitoring Plan and how do I get one?

What is a Data and Safety Monitoring Plan and how do I get one?. Presented by Office of Human Research Protection. For a study to be approved, one of the criteria that must be met is:

327 views • 14 slides

Unanticipated problems involving risk to subjects or others

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 . Unanticipated problems involving risk to subjects or others. Unanticipated problems involving risk to subjects or others.

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DHMH Institutional Review Board

DHMH Institutional Review Board. Research, Respect and Responsibility. DHMH IRB Staff. Gay Hutchen, IRB Administrator Chante Tindal, IRB Coordinator Pamela Owens, Esq., Chief, Corporate Compliance Officer. DHMH.

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MISSION COMMAND ADP 6-0

4.55k views • 11 slides

Unanticipated problems

Unanticipated problems. 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

236 views • 9 slides

Supervising for Excellence

Supervising for Excellence. Part Three: Supervisor as the Critical Link. Day Nine. Florida Department of Children and Families. Part Three: Day Nine Overview. Supervisor as Change Manager Project Presentations Leadership Panel/Peer Consultation & Action Planning.

181 views • 8 slides

SAE Reporting Requirements

474 views • 1 slides