№ lp_1_2_05529
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This document is a formal assurance submitted by institutions engaged in human subjects research, ensuring compliance with U.S. federal regulations for the protection of human subjects in research.
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]
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Region / City:
Oregon
Topic:
Fraud, Waste, and Abuse Prevention
Document Type:
Compliance Guidelines
Organization / Institution:
Oregon Health Authority (OHA)
Author:
Health Services Advisory Group, Inc. (HSAG)
Target Audience:
Coordinated Care Organizations (CCOs)
Period of Validity:
January 31, 2024
Approval Date:
January 31, 2024
Date of Changes:
Not specified
Year:
2025
Region / city:
Not specified
Topic:
FWA Devices Architecture and Requirements
Document Type:
Industry Specification
Organization / institution:
GSMA
Author:
GSMA
Target Audience:
Operators, Manufacturers, Service Providers
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Contextual description:
A detailed specification document for the architecture and requirements of Fixed Wireless Access (FWA) devices, outlining the necessary features and standards for integration with mobile networks across 4G, 5G NSA, and 5G SA technologies.
Year:
2022
Region / City:
Amman
Topic:
Graphic Design
Document Type:
Invitation to Tender
Organization:
Norwegian Refugee Council (NRC)
Author:
MERO Procurement Department
Target Audience:
Service Providers, Graphic Designers
Effective Period:
2 years
Approval Date:
16th May 2022
Amendment Date:
None
Contextual Description:
Invitation to tender for establishing a two-year framework agreement for graphic design services, particularly for the BLP programme materials, including layout, icon design, and branding.
Year:
2026
Region / City:
East Sudan
Theme:
Office Stationery Provision
Document Type:
Request for Quotation (RFQ)
Issuing Organization:
CRS
Target Audience:
Suppliers/Vendors
Period of Implementation:
March 1, 2026 – February 29, 2028
Approval Date:
N/A
Amendment Date:
February 15, 2026
Note:
Date
Topic:
Flexible Work Arrangement
Document Type:
Template
Target Audience:
Employees
Context:
Template document for employees to submit formal requests for flexible work arrangements to employers according to Tripartite Guidelines.
Division:
Fiscal and Operations Division, Office of Program Integrity
Subject:
Fraud, Waste and Abuse (FWA) Reporting
Document Type:
Referral Submission Form
Submitting Entities:
Oregon Health Authority Office of Program Integrity; DOJ Medicaid Fraud Control Unit
Submission Method:
Email
Geographic Scope:
Oregon
Related Program:
Medicaid
Fields Included:
Referral Information; Complainant Information; Other Contracting Entity Information; Provider Information; Suspected FWA Information; Investigation Status; Financial Exposure
Key Data Elements:
FWA Detected Date; Referral Date; Agency Reporting History; Provider Identifiers; Consumer Identifiers; Allegation Summary; Claims Date Range
Note:
Year
Theme:
Flexible working
Document Type:
Application form
Organization / Institution:
University
Author:
University
Target Audience:
University employees
Year:
2024
Region / City:
Idleb, North Aleppo, Northwest Syria
Theme:
Supply of Diesel Fuel
Document Type:
Invitation to Tender (ITT)
Organ / Institution:
GOAL
Author:
GOAL
Target Audience:
Diesel Fuel Suppliers
Validity Period:
12 months (with option for 2 extensions)
Approval Date:
22nd March 2024
Amendment Date:
31st March 2024, 5th April 2024
Tender Name:
Supply of Fuel to DRC offices
Tender Number:
ITB-SSD-JUB-2020-008
Tender Issuing Date:
26 October 2020
Clarification Closing Date:
02 November 2020
Tender Closing Date:
10 November 2020 at 2.00 EAT
Region / City:
Juba, South Sudan
Sector:
Humanitarian Aid
Document Type:
Tender
Organization:
Danish Refugee Council (DRC)
Target Audience:
Service providers for fuel supply
Start Date:
26 October 2020
End Date:
10 November 2020
Contact:
[email protected]
Funding Source:
Various Donors
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
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
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.