№ lp_1_2_57730
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Administrative form outlining required information and procedures for notifying an institutional review board about planned reliance arrangements for multi-site human subjects research and coordinating oversight responsibilities.
Document type:
Administrative form
Subject area:
Human subjects research oversight
Regulatory context:
Institutional Review Board reliance and authorization
Applicable research type:
Collaborative multi-site research involving human subjects
Institution:
Campbell University
Responsible office:
Campbell IRB Office
Jurisdiction:
United States
Intended use:
Notification and coordination of IRB oversight
Related process:
IRB application and reliance agreement determination
Form status:
Not an IRB application
Source type:
Institutional administrative record
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2022
Note:
Region / City
Topic:
Data and Safety Monitoring, Clinical Trials, Study Reporting
Document Type:
Instruction Sheet, Report Template
Organization / Institution:
NIAMS
Target Audience:
Investigators, Study Team Members, Data Managers, Study Statisticians, Monitoring Body
Contextual Description:
Instruction sheet for preparing data and safety monitoring reports for multi-site clinical studies.
Year:
2020
Note:
Region / City
Topic:
Clinical Research
Document Type:
Guideline
Organization / Institution:
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Target Audience:
Researchers, Clinical Trial Coordinators, Investigators
Form number:
CER-NGER-015
Version:
1.0
Date of issue:
7 January 2025
Jurisdiction:
Australia
Regulatory framework:
National Greenhouse and Energy Reporting Regulations 2008
Scheme:
National Greenhouse and Energy Reporting Scheme
Related mechanism:
Safeguard Mechanism
Type of document:
Regulatory nomination form
Issuing authority:
Clean Energy Regulator
Subject matter:
Nomination of multi-site cement production facilities
Eligible activities:
Cement production attributable to Portland cement clinker
Reporting period applicability:
Activities conducted on or after 1 July 2023
Approval deadline:
30 June of the relevant financial year
Submission methods:
Post and email
Target entities:
Operators of multi-site cement production businesses
Administrative purpose:
Facility nomination and variation of existing nominations
Year:
2023
Document Type:
GHG Project Plan Appendix
Organization:
American Carbon Registry (ACR)
Version:
1.1
Date Published:
2023-12-01
Scope:
Multi-Site GHG Projects
Project Approach:
Aggregated or Programmatic Development Approach (PDA)
Validation Status:
Subject to validation and public disclosure
Year:
2023
Document type:
Pre-audit checklist
Program:
Chain of Custody certification
Standard referenced:
MSC Chain of Custody Standard: Default Version
Related standard:
ASC Chain of Custody Standard
Issuing organization:
Marine Stewardship Council
Copyright holder:
Marine Stewardship Council
Version:
2.1
Official language:
English
Intended users:
Single-site and multi-site organisations handling certified seafood
Certification scope:
MSC and ASC certified seafood products
Content focus:
Purchasing, identification, segregation, labelling, and promotion of certified products
Status:
Guidance document
Publication source:
MSC website
Year:
2020
Note:
Region / City
Topic:
Clinical Trials, Closeout Procedures
Document Type:
Procedure Guidelines
Organization / Institution:
NIAMS
Target Audience:
Researchers, Clinical Trial Coordinators, IRB Members, Study Site Personnel
Year:
2017
Region / City:
United States
Topic:
Clinical Research, Multi-Site Clinical Trials
Document Type:
Manual, Guidelines
Organization / Institution:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Author:
NIAMS
Target Audience:
Researchers, Clinical Trial Coordinators
Period of Action:
October 2017 and onwards
Approval Date:
October 2017
Date of Modifications:
Not specified
Year:
Not specified
Region / City:
United States
Topic:
Medical research protocols, ethics
Document type:
Protocol Addendum
Institution:
United States Army Medical Research and Development Command (USAMRDC)
Author:
Not specified
Target audience:
Research institutions, ethics committees
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Date:
March 31, 2025
Place:
Zurich, Switzerland
Company:
ABB Ltd
Division:
Smart Buildings Division, Energy Distribution Business Line
Product:
ABB Ability™ InSite Energy Pro
Platform Type:
Cloud-based energy management platform
Technology Partner:
AWS
Related Standard:
ISO 50001
Event:
Hannover Fair (March 31 – April 4, Hall 15, Stand D76)
Industry Sector:
Energy management and electrification
Target Audience:
Building owners, developers, energy managers of multi-dwellings and mid-sized commercial properties
Contact:
[email protected]
Address:
Affolternstrasse 44, 8050 Zurich, Switzerland
Year:
2026
Region / City:
Not specified
Subject:
Research Study Coordination and IRB Communication
Document Type:
Template / Protocol Guide
Institution:
Multiple participating institutions
Authors:
Not specified
Target Audience:
Research study teams, IRB personnel
Effective Period:
Duration of the study
Key Roles:
Reviewing IRB POC, Lead Study Team Representative, Relying Site POC, Relying Site Study Team Representative
Responsibilities:
Conflict of Interest management, study team training, local considerations, IRB application and review, consent form management, continuing review, reportable events, closure reports
Communication Channels:
Email, institutional portals, direct contact
Year:
Not specified
Region / City:
Not specified
Subject:
Human Research Protection, Institutional Review Board
Document Type:
Procedure
Organization / Institution:
Rutgers University
Author:
Not specified
Target Audience:
Principal Investigators, IRB Administrators, Reliance Administrators, External Institution Research Teams
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Institution:
West Virginia University
Document type:
Investigator Manual
Scope:
Participating Site (pSite) responsibilities for Human Research under a single IRB
Audience:
Research investigators and study staff
Regulatory framework:
Federal human research protections and local institutional policies
Required training:
Human research protections training for all study personnel
Submission system:
WRAP SmartForms
Approvals:
sIRB approval and local institutional approvals
Responsible party:
Lead study team and pSite investigator
Key procedures:
Consent documentation, ongoing reporting, site-specific study management
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