№ lp_1_27190
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This document outlines the role, requirements, and components of a Data Safety Monitoring Plan (DSMP) in human subjects research, detailing the processes for ensuring safety, data integrity, and compliance with institutional review board (IRB) standards.
Year:
2022
Region / City:
New York, NY
Topic:
Data Safety Monitoring Plan (DSMP) for human subjects research
Document Type:
Guidance
Institution:
Institutional Review Board (IRB)
Author:
Not specified
Target Audience:
Researchers and Investigators conducting human subjects research
Effective Period:
Not specified
Approval Date:
03.07.2022
Amendment Date:
Not specified
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Institution:
Fred Hutchinson Cancer Center
Affiliated institutions:
University of Washington
Document type:
Model informed consent form
Research domain:
Clinical research
Regulatory framework:
45 CFR 46.116; 21 CFR 50.25
Oversight body:
Fred Hutch IRB; OHRP; FDA
Principal Investigator:
Chris Doe MD PhD
Intended use:
Consent for participation in clinical research studies
Population:
Prospective research participants, parents or guardians, legally authorized representatives
Study phases referenced:
Phase 1; Phase 2; Phase 3
Risk level:
More than minimal risk (when applicable)
Geographic scope:
United States
Language of document:
English
Year:
2024
Region / city:
China, New Zealand, Egypt, Philippines, Arab countries
Theme:
Scientific and technological cooperation, international research projects
Document type:
Agreement, Cooperation guidelines
Organization / institution:
Ministry of Science and Technology of China, New Zealand Ministry of Business, Innovation and Employment, Egyptian Ministry of Higher Education and Scientific Research, Department of Science and Technology of the Philippines
Author:
N/A
Target audience:
Government bodies, research institutions, international cooperation teams
Duration:
2-3 years
Approval date:
2024
Amendment date:
N/A
Document type:
Agreement
Institution:
Oregon State University
Program:
Human Research Protection Program
Oversight body:
Institutional Review Board
Research area:
Human subjects research
Parties:
Individual Investigator; Oregon State University
Compliance framework:
International, federal, state, and local laws and regulations
Training requirements:
Research ethics training; CITI or equivalent
Approval requirement:
Institutional Review Board review and approval
Signature fields:
Investigator; HRPP Administrator
Year:
2023
Region / city:
Not specified
Subject area:
Social Welfare, Social Work, Human Rights
Document type:
Course syllabus
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Students
Validity period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2020
Jurisdiction:
United States
Subject area:
Human subjects research oversight
Document type:
Regulatory guidance and comparison
Issuing authority:
U.S. Department of Defense
Implementing body:
U.S. Army Medical Research and Development Command Office of Human and Animal Research Oversight
Referenced regulation:
DoDI 3216.02
Scope:
DoD-supported research involving human subjects
Affected organizations:
Non-DoD institutions receiving DoD support
Approval authority:
Office of Human Research Oversight
Focus:
IRB review, assurances, training, reporting, and protocol modifications
Note:
Year
Topic:
Human subjects research, participant compensation, IRS regulations
Document Type:
Institutional Policy
Institution:
Purdue University
Target Audience:
Researchers, Institutional Review Board
Year:
2021
Region / City:
MCW
Topic:
Quality Improvement, Human Subjects Research
Document Type:
Checklist
Organization / Institution:
Medical College of Wisconsin
Author:
Not specified
Target Audience:
Researchers, Medical Professionals
Effective Period:
Not specified
Approval Date:
7/1/2021
Date of Changes:
7/1/2021
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Year:
2023
Region / City:
United States
Topic:
Human Subjects Research, Institutional Compliance
Document Type:
Government Form
Organization:
U.S. Department of Health & Human Services (HHS)
Author:
U.S. Government
Target Audience:
Institutions engaged in human subjects research
Effective Period:
Ongoing
Approval Date:
[Not provided]
Amendment Date:
[Not provided]
Note:
Year
Subject:
Research Ethics, Human Subjects, IRB Review
Document Type:
Application Form
Organization / Institution:
University of Mary Washington
Target Audience:
Researchers, Faculty, Students
Year:
2020
Region / City:
Oxford
Subject:
Education, Admissions
Document Type:
Interview Guidelines
Institution:
University of Oxford
Authors:
Dalveen, Jessica Goodman, Tom Crawford, Matthew Williams, Hannah Skoda, Will Poole, Ian (Admissions Operations Team)
Target Audience:
Prospective Students
Period of Action:
2020
Approval Date:
Not specified
Revision Date:
Not specified
Year:
2026
Region / City:
United States
Topic:
Human subjects, clinical trials, enrollment reporting
Document type:
Guidelines
Organ / Institution:
NIH
Author:
Not specified
Target audience:
Researchers and investigators conducting human subjects studies
Period of validity:
01/31/2026
Date of approval:
Not specified
Date of amendments:
Not specified
Note:
Year
Subject Matter:
Human Subjects Research Determination
Document Type:
Template
Institution:
Auburn University
Target Audience:
Researchers and Investigators
Note:
Year
Region / City:
Georgia
Document Type:
Monitoring Report
Submitted by:
UST Owner/Operator
Prepared by:
Consultant/Contractor
Professional Certification:
Registered Professional Engineer or Professional Geologist
Site Assessment:
Groundwater monitoring, analytical results, site ranking
Reimbursement Details:
Applicable if checked
Tables Included:
Groundwater elevations, analytical results, HVR events
Figures Included:
Site location map, potentiometric surface maps, groundwater quality maps, contaminant trend graphs
Year:
2026
Region / City:
Somerset East
Theme:
Guarding Services, Alarm Systems, Armed Response
Document Type:
Tender
Organization / Institution:
Blue Crane Route Municipality
Author:
Not specified
Target Audience:
Potential service providers
Period of Validity:
3 years
Approval Date:
09 January 2026
Date of Changes:
Not specified
Year:
N/A
Region / city:
N/A
Topic:
Program/Project Management
Document Type:
Report
Organization:
Federal Agency
Author:
N/A
Target audience:
N/A
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Context:
Report template for monitoring and assessing the progress of a federal program or project, detailing management and performance indicators.
Note:
Year
Context description:
Report on activity-based expenditures and funding allocation within federal grants, including reporting periods and detailed activity descriptions.
Year:
2019
Region / City:
United States
Topic:
Information Technology, Veterans Affairs, Healthcare
Document Type:
Performance Work Statement
Agency / Institution:
Department of Veterans Affairs, Office of Information & Technology
Author:
Not specified
Target Audience:
Contractors, VA staff, IT professionals
Period of Effectiveness:
June 27, 2019, onwards
Approval Date:
June 27, 2019
Amendments Date:
Not specified