№ lp_1_2_63543
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Character count: 14440
File size: 303 KB
Provides a detailed procedural and regulatory framework for the identification, assessment, documentation, and reporting of adverse events, serious adverse events, and unanticipated problems in clinical trials.
Year:
Not specified
Region/Institution:
University of Michigan
Document Type:
Standard Operating Procedure (SOP)
Topic:
Clinical Trial Safety Reporting
Regulations Referenced:
ICH GCP Section 4.11, 21 CFR 312.32, 21 CFR 812.150
Target Audience:
Clinical trial staff including Principal Investigators, Co-Investigators, Study Coordinators, and research professionals
Approval Date:
Not specified
Scope:
Identification, assessment, recording, and reporting of AEs, SAEs, UADEs, and UaPs
Definitions Included:
Adverse Event, Serious Adverse Event, Unanticipated Adverse Device Effect, Unanticipated Problem, Co-Investigator, DSMB, IRB, IDE, IND, Life-threatening Adverse Event
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
Not specified
Region / City:
Not specified
Topic:
Ethics, Research, Clinical Trials
Document Type:
Report Form
Organ / Institution:
Parkway Independent Ethics Committee (PIEC)
Author:
Not specified
Target Audience:
Research investigators, ethics committee members
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Topic:
Cultural resources management
Document Type:
Procedures
Agency / Organization:
Washington State Department of Transportation
Target Audience:
WSDOT employees, contractors, archaeologists
Year:
2020
Region / City:
Bethlehem
Topic:
Solid waste management, recycling, landfill closure
Document Type:
Contingency plan
Organization / Institution:
Bethlehem Advisory Transfer Station Committee
Author:
Bethlehem Advisory Transfer Station Committee
Target Audience:
Select Board, Bethlehem Town Officials, Regional Solid Waste Experts
Effective Period:
May 2020 – ongoing
Approval Date:
May 2020
Date of Changes:
Not specified
Document Type:
Institutional guidance policy
Subject:
Management and reporting of unanticipated problems and adverse events in human subjects research
Organization:
UT Houston CPHS
Responsible Role:
Principal Investigator
Scope:
Human subjects research including clinical trials
Related Institutions:
Memorial Hermann Hospital; Harris County Hospital District
Regulatory References:
IRB; FDA; Investigator Brochure; MedWatch; CIOMS; IND Safety Reports; SUSAR reports
Jurisdiction:
United States; Singapore (for investigational product regulatory context)
Key Topics:
Adverse events; Serious adverse events; Unexpected adverse drug experiences; Protocol violations; Confidentiality breaches; Safety monitoring; Corrective action plans
Document Type:
Standard Practice Guideline
Subject Area:
Clinical research safety and adverse event reporting
Regulatory Framework:
Good Clinical Practice (ICH GCP)
Regulatory References:
ICH GCP Sections 4.11.1, 4.11.2, 5.16, 5.17; 21 CFR 312.53, 312.64, 312.66, 312.32; 21 CFR 812.150
Institution:
University of Michigan Institutional Review Board (IRBMED)
Applicable To:
Clinical trial staff including Principal Investigator, Sponsor-Investigator, Co-Investigator, Study Coordinators, and research personnel
Key Topics:
Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Adverse Device Effects (UADE), Unanticipated Problems (UaP)
Responsible Roles:
Principal Investigator, Sponsor-Investigator, Co-Investigators, Study Coordinators, Data and Safety Monitoring Board
Research Context:
Human subjects clinical trials
Reporting Authorities:
Sponsor, Institutional Review Board (IRB), Food and Drug Administration (FDA)
Geographical Context:
United States regulatory environment
Compliance Basis:
Federal regulations and institutional research oversight policies
Purpose:
Procedures and responsibilities for identification, assessment, documentation, and reporting of safety events in clinical studies
Note:
Year
Note:
Year
Year:
2003
Region / City:
Mount Sinai Hospital
Subject:
Clinical Research
Document Type:
Guideline
Organization / Institution:
Mount Sinai Hospital REB
Author:
REB Chair
Target Audience:
Clinical Investigators, Research Staff
Effective Period:
Ongoing
Approval Date:
November 6, 2003
Revision Date:
July 8, 2015
Year:
2023
Region / City:
Florida
Theme:
Legal Procedure
Document Type:
Statutory Instruction
Authority / Institution:
Florida State
Author:
Unknown
Target Audience:
Legal Professionals
Period of Validity:
Not specified
Approval Date:
December 15, 2023
Modification Date:
December 15, 2023
Year:
2023
Region / City:
Birmingham
Topic:
Clinical Research, Deviation and Breach Reporting
Document Type:
Standard Operating Procedure (SOP)
Organ / Institution:
University of Birmingham
Author:
Unknown
Target Audience:
Clinical research staff, investigators, research teams, compliance officers
Period of validity:
Effective from the date of publication
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
UK
Topic:
Risk Assessment, Offender Management
Document Type:
Guidance
Organ / Institution:
OASys Business Team
Author:
OASys Business Team
Target Audience:
OASys users (court staff, YOT staff, offender managers, keyworkers)
Period of Validity:
Not specified
Approval Date:
January 2021
Date of Changes:
Not specified
Year:
2017
Region / City:
North Hampton, MA
Subject:
Homeless Veterans with Serious Mental Illness Services
Document Type:
Solicitation Notice
Organ / Institution:
Department of Veterans Affairs
Author:
Corey L. Labbe
Target Audience:
Contractors
Period of Performance:
06-01-2017 to 05-31-2018 (with multiple option years)
Approval Date:
05-22-2017
Amendment Date:
N/A
Performance Location:
North Hampton VA Medical Center
NAICS Code:
624221
Contract Number:
VA241-17-Q-0332
Contact Information:
Corey L. Labbe, Contract Specialist, 207-623-8411 X-2229
Email:
[email protected]
Additional Information:
Full and open competition, NAICS code 624221 - Temporary Shelter Services
Context:
This document outlines a combined synopsis/solicitation for providing residential services for homeless veterans with serious mental illness at the North Hampton VA Medical Center.
Year:
2023
Region / City:
USA
Topic:
Firefighter injury and death notification procedures
Document type:
Standard Operating Procedure (SOP)
Organization / Institution:
Fire Department
Author:
Fire Department
Target audience:
Fire department personnel
Period of validity:
Ongoing
Approval date:
N/A
Date of amendments:
N/A
Year:
2008
Region / City:
Not specified
Topic:
Public Service Discipline
Document Type:
Form
Agency / Organization:
Public Service
Author:
Not specified
Target Audience:
Applicants for public service roles
Effective Period:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2025
Region / City:
United States
Subject:
Serious Adverse Event Reporting
Document Type:
Form
Organization / Institution:
National Cancer Institute (NCI)
Author:
National Cancer Institute
Target Audience:
Clinical Investigators, Medical Monitors, Research Staff
Effective Period:
Ongoing
Approval Date:
09/04/2025
Modification Date:
10/01/2024
Year:
2023/2024
Region/City:
Capital, Coast and Hutt Valley
Theme:
Healthcare, Patient Safety
Document Type:
Report
Organization/Institution:
Health New Zealand | Te Whatu Ora
Author:
Health New Zealand | Te Whatu Ora
Target Audience:
Healthcare professionals, policymakers, public health officials
Period of Validity:
1 July 2023 – 30 June 2024
Approval Date:
September 2025
Date of Changes:
Not specified
Note:
Year
Year:
2025
Region / City:
Belfast, Stormont Estate
Topic:
Serious Adverse Incident Process Review
Document Type:
Consultation Response Form
Organ / Institution:
Department of Health
Author:
Department of Health
Target Audience:
Individuals, Organisations involved in Patient Safety
Period of Validity:
Until 6 June 2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
XXXXXXX
Theme:
Eventing, Horse Riding, Emergency Procedures
Document Type:
Template
Organization:
FEI (Fédération Équestre Internationale)
Author:
Not specified
Target Audience:
Event Organizers, Medical and Veterinary Teams, Event Officials
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified