№ lp_1_14747
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Character count: 4633
File size: 105 KB
This document is a report form for the documentation and communication of serious adverse events (SAEs) in clinical trials.
Note:
Year
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The product description is provided for reference. Actual content and formatting may differ slightly.
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
State:
Oklahoma
Demonstration name:
Institutions for Mental Diseases Waiver for Serious Mental Illness/Substance Use Disorder
Approval period for section 1115 demonstration:
12/22/2020-12/31/2025
SMI/SED demonstration start date:
12/22/2020
Implementation date of SMI/SED demonstration:
12/22/2020
SMI/SED demonstration goals and objectives:
Reduced utilization of emergency departments; Reduced preventable readmissions to acute care hospitals and residential settings; Improved availability of crisis stabilization services; Improved access to community-based services; Improved care coordination
SMI/SED demonstration year and quarter:
DY1 Q2
Reporting period:
04/01/2021 - 06/30/2021
Medicaid expansion start date:
07/01/2021
Managed care implementation status:
On hold pending legislative authority
Behavioral Health Homes sunset date:
09/30/2021
Certified Community Behavioral Health Clinics (CCBHCs) certified this period:
1
Total new CMHCs achieving CCBHC status since waiver submission:
4
State agency:
Oklahoma Department of Mental Health and Substance Abuse Services (ODMHSAS)
Relevant national initiatives:
988 crisis response number
Year:
2019
Region / city:
OECD
Topic:
Adverse Outcome Pathway, oxidative stress, brain development, neurotoxicity
Document Type:
External Review Report
Author:
OECD EAGMST review manager
Target Audience:
Scientific community, regulators, policymakers
Period of validity:
Not specified
Approval Date:
June 2018
Date of revisions:
17 March 2020
Year:
2024
Region / city:
UK
Topic:
Climate change, extreme weather, workplace safety
Document type:
Policy document
Organization / institution:
UNISON, TUC
Author:
UNISON
Target audience:
Trade union representatives, employers, workers
Period of validity:
2024–2025
Approval date:
Not specified
Date of changes:
Not specified
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:
2026
Region / City:
Boston, MA
Topic:
Clinical Research, Adverse Event Reporting
Document Type:
Form
Author:
BU Medical Campus
Target Audience:
Clinical research staff
Period of validity:
Ongoing
Approval Date:
2026-01-01
Date of Changes:
Not specified
Year:
2019
Region / City:
International
Subject:
Medical device adverse event reporting
Document Type:
Proposed document
Organ / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity:
Not specified
Approval date:
27th June 2019
Date of Changes:
Not specified