Adverse Event Reporting PowerPoint Presentations - PPT

Expedited  Adverse Event
Expedited Adverse Event - presentation

pasty-tole

Reporting Requirements. Protocol References. Section. Title. 7.2. Safety-Related. Data Collection. 7.3. Expedited Adverse Event Reporting. Other References and Resources. 3. Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0).

SAFETY PRACTICES AND REPORTING IN CLINICAL RESEARCH
SAFETY PRACTICES AND REPORTING IN CLINICAL RESEARCH - presentation

min-jolico

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.

Lessons to learn from the reporting of adverse events in RCTs published in four high impact journal
Lessons to learn from the reporting of adverse events in RCT - presentation

phoebe-cli

Rachel Phillips & Victoria Cornelius. Review. “recommended improvements in the accuracy of harm data in RCT reports and a need to standardize practices for reporting.”. Review. “found that methods used to collect adverse event data, the frequency of collection, and the selection criteria used by authors for reporting adverse events vary substantially, and these events are often inadequately reported.”.

Expedited
Expedited - presentation

phoebe-cli

Adverse Event . Reporting Requirements. Protocol References. Section. Title. 7.2. Safety-Related. Data Collection. 7.3. Expedited Adverse Event Reporting. Other References and Resources. 3. Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0).

Adverse Events
Adverse Events - presentation

sherrill-n

, 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.

AE/SAE/EAE  Identification and Reporting
AE/SAE/EAE Identification and Reporting - presentation

giovanna-b

. Presentation Overview. PSRT queries. Safety Physicians. Adverse Events. PSRT Query Process. <. 72 . hours. Email to . (. mtn028safetymd@mtnstopshiv.org. ) . Your Protocol Safety Physicians. Devika Singh.

FDA Final Rule & Revised NCI Guidelines for Expedited Reporting of Adverse Events
FDA Final Rule & Revised NCI Guidelines for Expedited Re - presentation

mitsue-sta

S. Percy Ivy, MD. Associate Chief, Senior Investigator. Investigational Drug Branch, National Cancer Institute. ivyp@ctep.nci.nih.gov. . National Cancer Institute. . National Cancer Institute.

FDA Final Rule & Revised NCI Guidelines for Expedited Reporting of Adverse Events
FDA Final Rule & Revised NCI Guidelines for Expedited Re - presentation

lois-ondre

S. Percy Ivy, MD. Associate Chief, Senior Investigator. Investigational Drug Branch, National Cancer Institute. ivyp@ctep.nci.nih.gov. . National Cancer Institute. . National Cancer Institute.

A series of randomised controlled N-of 1 trials in patients
A series of randomised controlled N-of 1 trials in patients - presentation

tatyana-ad

placebo. REPORTING ADVERSE EVENTS AND COMPLETING THE REPORT FORM. Trial protocol code: ISRCTN30952488. Version 1, 17 November 2016. THIS PRESENTATION MUST BE USED WITH:. The Trial Protocol (. Section 2.9).

A series of randomised controlled N-of 1 trials in patients who have discontinued or are considerin
A series of randomised controlled N-of 1 trials in patients - presentation

min-jolico

placebo. REPORTING ADVERSE EVENTS AND COMPLETING THE REPORT FORM. Trial protocol code: ISRCTN30952488. Version 1, 17 November 2016. THIS PRESENTATION MUST BE USED WITH:. The Trial Protocol (. Section 2.9).

Safety of the Subject  Cena Jones-Bitterman, MPP, CIP, CCRP
Safety of the Subject Cena Jones-Bitterman, MPP, CIP, CCRP - presentation

natalia-si

Holden Comprehensive Cancer Center. Protocol Development and Monitoring . Key definitions. Identifying, documenting and reporting Adverse Events. Investigator Responsibilities . How are research participants protected? .

Remote Monitoring of Adverse Events
Remote Monitoring of Adverse Events - presentation

conchita-m

Dee Blumberg, PhD. An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . (21 CFR 312.32).. Adverse Events. An adverse event or suspected adverse reaction is considered “serious” if, in the view of .

Unanticipated Problems
Unanticipated Problems - presentation

pamella-mo

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 .

Updated September  Page of Healthcare Facility HAI Reporting Requirements to CMS via NHSN  Current or Proposed Requirements CMS Reporting Program HAI Event Reporting Specifications Reporting Start Da
Updated September Page of Healthcare Facility HAI Reporting - pdf

test

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

Postmarket  monitoring Overview
Postmarket monitoring Overview - presentation

conchita-m

What is . postmarket. monitoring?. Why is it important?. Tools used in . postmarket. monitoring. Managing risk. Adverse events. Risk management plans. Signals. Early warning system. Recall. actions.

Critical Thinking about Institutional Disclosure
Critical Thinking about Institutional Disclosure - presentation

trish-goza

of Adverse Events to Patients . August 6. , 2012 (Call 2 of 2). Sponsoring Offices:. National Center for Ethics in Health Care . Office of Quality, Safety and Value, Risk Management Program. 1. Welcome.

FDA Final Rule & Revised CTEP Guidelines for Expedited
FDA Final Rule & Revised CTEP Guidelines for Expedited - presentation

stefany-ba

S. Percy Ivy, MD. Associate Chief, Senior Investigator. Investigational Drug Branch, National Cancer Institute. ivyp@ctep.nci.nih.gov. . National Cancer Institute. . . Cancer Therapy Evaluation Program (CTEP).

Event Repository Reporting
Event Repository Reporting - presentation

calandra-b

Mark Hawkins. ACACSO. May 11 – 13, 2016. 2. Idaho. History. Event Lifecycle. Dependencies. Idaho?. Originally included in the Washington territory and included Montana & Wyoming . George M Willing – Shoshone “the sun comes from the mountains” .

Dartmouth Human Research Protection Program (HRPP)
Dartmouth Human Research Protection Program (HRPP) - presentation

stefany-ba

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 .

Dartmouth Human Research Protection Program (HRPP)
Dartmouth Human Research Protection Program (HRPP) - presentation

karlyn-boh

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 .

IRB reporting updates  Main Points
IRB reporting updates Main Points - presentation

ellena-man

Simplified process. Electronic submission to IRB. “Robust” guidance from HSO. One reporting mechanism (no separate forms). New 60 day amendment submission deadline. IRB Makes the Determination. When .

Monitoring and reporting of medication errors
Monitoring and reporting of medication errors - presentation

min-jolico

By. Tsneem. . Tagelsir. . Khider. Medication safety. What is “medication error”?. Error . . Failure. of a planned action to be completed as intended. Medication error . Any . preventable event .

Event Reporting Theory and Practice
Event Reporting Theory and Practice - presentation

kittie-lec

AIRS – Anesthesia Incident Reporting System. Patrick Guffey MD. Chair, AQI AIRS Steering Committee. Richard Dutton MD MBA. Chief Quality Officer, AQI. Lance Mueller. Director, AQI. June 26, 2014. Insights.

Comparison Study of EIMC Devices and Pilot Implementation i
Comparison Study of EIMC Devices and Pilot Implementation i - presentation

sherrill-n

Rebeca M. Plank, MD MPH. Brigham and Women’s Hospital / . Botswana-Harvard School of Public Health AIDS Institute Partnership. Early Infant Male Circumcision (EIMC): . Safety and Sustainability. Minimal bleeding.

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