№ lp_1_2_51233
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Character count: 5825
File size: 42 KB
This document provides guidelines for conducting clinical trial closeout procedures at multiple study sites, detailing administrative tasks, data management, and participant notification requirements.
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
Price: 8 / 10 USD
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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
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
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
Program:
FHWA Emergency Relief (ER)
Document type:
Inspection and closeout checklist
Repair category:
Permanent repair
Issuing authority:
Federal Highway Administration
Intended use:
Field inspections and final project reviews
Project phase:
Final closeout
Authorization requirement:
FHWA project authorization prior to construction
Environmental compliance:
NEPA, permits, Section 106, ESA
Financial documentation:
Federal-aid eligible cost verification and final estimates
Construction compliance:
Buy America, Davis-Bacon, materials certifications
Audit readiness:
Documentation retention and procurement compliance
Administrative reference:
DDIR, PS&E, federal-aid project agreements and forms
Year:
2020
Region / City:
Not specified
Topic:
Clinical trial procedures
Document Type:
Clinical trial protocol
Institution:
NIAMS
Author:
Not specified
Target Audience:
Research staff, clinical trial personnel
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2021
Region / City:
Canberra
Theme:
Clinical Trials, Research Procedures
Document Type:
Procedure Manual
Organization:
Canberra Health Services
Author:
Clinical Trials Unit
Target Audience:
CHS Staff involved in clinical trials
Period of Effect:
Indefinite
Approval Date:
17/09/2021
Amendment Date:
Not specified
Document Status:
Controlled, subject to updates
Note:
Year
Note:
Year
Region / City:
Central Region, Alaska
Topic:
Project Closeout, Highway Design
Document Type:
Guide
Organization:
Alaska Department of Transportation & Public Facilities (DOT&PF)
Author:
Chris Post, P.E., Fred Park, P.E., Steven Rzepka, P.E., Devki Rearden, Ryan Norkoli, P.E.
Target Audience:
DOT&PF staff, consultants, contractors
Effective Period:
Ongoing, updates periodically
Approval Date:
Not specified
Date of Last Update:
Not specified
Jurisdiction:
State of Kansas
Department:
Department of Administration, OFPM-DCC
Document type:
Project closeout checklist
Project scope:
Construction projects
Responsible party:
Contractor
Reviewing parties:
Owner; Project Architect/Engineer
Approval requirement:
Completion and verification prior to final payment
Related documentation:
Certificate of (Partial) Occupancy; Record Documents; Operations and Maintenance manuals
Associated form:
Form 571 – Certificate of Project Completion / Affidavit of Contractor
Year:
2023
Region / City:
United States
Subject:
Subcontract closeout process
Document Type:
Internal Procedure
Organization / Institution:
Leidos
Author:
Leidos
Target Audience:
Contractors and subcontractors
Period of Action:
Ongoing as per subcontract agreements
Approval Date:
N/A
Date of Amendments:
N/A
Section number:
017800
Document title:
Closeout Submittals
Discipline:
Construction administration
Subject:
As-Built Documents and Record Documents
Document type:
Specification section
Project phase:
Closeout
Responsible parties:
Contractor; Design Professional; Architect
Related sections:
01 7700 – Closeout Procedures; Divisions 02 through 49
Submittal types:
As-Built; Shop Drawings; O&M; Warranty; Record Documents
Formats required:
PDF; CAD (.dwg)
Digital platform:
eBuilder
Update frequency:
Weekly during construction
Review period:
5 business days
Timing of submittal:
At Substantial Completion
Scope of work covered:
Architectural; Structural; Civil; Landscape; FLS; MEP; Fire Sprinkler; Fire Alarm; Building Automation; Security/Access; Nurse Call; ITG
Standards for revisions:
Clouded, dated, and numbered revisions during construction; removed in final record set
Ownership of final record set:
Owner