№ files_lp_3_process_7_060501
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Institutional policy text defining terms, criteria, responsibilities, identification procedures, management steps, and reporting obligations for unanticipated problems and adverse events in research overseen by UT Houston CPHS and the IRB.
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
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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
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
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
Topic:
University examinations, extensions, and excusals
Document type:
Student guide
Institution:
University of Oxford
Target audience:
University students
Year:
2024
Region / City:
Sheffield
Theme:
Cognitive Behavioural Therapy, Mental Health, Postgraduate Education
Document Type:
Academic Information Guide
Organization:
University of Sheffield
Author:
University of Sheffield
Target Audience:
Healthcare professionals, postgraduate students
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Last Update:
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:
2023
Region / City:
Cyprus
Theme:
Sustainable Heritage Management, Accelerator Science, Technology
Document Type:
Research Paper
Organization / Institution:
The Cyprus Institute
Author:
Kirsi O. Lorentz
Target Audience:
Researchers, Heritage Professionals, Policy Makers
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Contextual description
Year:
2021
Region / City:
Global
Topic:
Networking Troubleshooting
Document Type:
Instructor Guide
Organization:
Cisco Networking Academy
Author:
Cisco Systems
Target Audience:
Networking instructors
Effective Date:
N/A
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2020
Region / City:
Brussels
Topic:
Artificial Intelligence, Cognitive Architectures, Automation
Document Type:
Proposal Template
Organization / Institution:
Human Brain Project
Author:
Not specified
Target Audience:
Applicants, all interested
Validity Period:
Until 16 October 2020
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Russia
Topic:
Education for people with disabilities
Document Type:
Report
Organization:
Human Rights Watch
Author:
Human Rights Watch
Target Audience:
General public, policymakers, educators, disability rights advocates
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2026
Region / city:
Global
Topic:
Mental Health, Discrimination, Stigma
Document type:
Research Article
Author:
Ioannis Bakolis, Graham Thornicroft, Silia Vitoratou, Nicolas Rüsch, Chiara Bonetto, Antonio Lasalvia, Sara Evans-Lacko
Target audience:
Researchers, Mental Health Professionals
Period of validity:
Ongoing
Date of approval:
2026
Date of changes:
None
Year:
2016
Region / City:
Naivasha, Kenya
Topic:
Tea Economy, Market Development, Smallholder Tea, Climate Change
Document Type:
Provisional Agenda
Organization / Institution:
Intergovernmental Group on Tea
Author:
Committee on Commodity Problems
Target Audience:
Delegates and members of the Intergovernmental Group on Tea
Period of Effect:
25-27 May 2016
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Summary
Year:
Not provided
Region / City:
Not provided
Theme:
Research methodology
Document type:
Academic paper
Organization:
AGH University of Science and Technology Press
Author:
Not specified
Target audience:
Researchers, academics, students
Period of validity:
Not specified
Approval date:
Not provided
Date of amendments:
Not provided
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
Year:
2009
Applies to:
SQL Server 2008
Type of Document:
Technical Article / White Paper
Authors:
Sunil Agarwal, Boris Baryshnikov, Keith Elmore, Juergen Thomas, Kun Cheng, Burzin Patel
Technical Reviewers:
Jerome Halmans, Fabricio Voznika, George Reynya
Publisher:
Microsoft Corporation
Publication Date:
March 2009
Topics:
Database performance, SQL Server troubleshooting, resource bottlenecks, memory and I/O optimization, tempdb management, query performance
Intended Audience:
Database administrators, IT professionals
Tools Covered:
SQL Server Profiler, Performance Monitor, Dynamic Management Views, Extended Events, Data Collector
Year:
2024
Region / City:
United Kingdom
Topic:
Nuclear Safety Culture, Organisational Culture
Document Type:
Guideline
Organisation / Institution:
Office for Nuclear Regulation (ONR)
Author:
Principal Inspector – Nuclear Safety
Target Audience:
ONR Human and Organisational Capability Specialist Inspectors
Period of Validity:
Until November 2029
Approval Date:
November 2024
Revision Date:
November 2025
Note:
Year
Topic:
Mechanical Engineering / Gears, Pulley Systems, and Sprockets
Document Type:
Answer Key
Target Audience:
Engineering students or professionals