№ lp_1_27235
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This document outlines the procedures for closing out a clinical trial, detailing the steps for both site and participant closeout activities and necessary administrative tasks.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2020
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Document Type:
Guidelines and Template
Scope:
Single-site clinical trial procedures
Version:
v.All
Date of Issue:
December 2020
Target Audience:
Study teams and administrative support staff
Protocol Number:
[Not specified]
Study Principal Investigator:
[Not specified]
Site Name:
[Not specified]
Grant/Contract Number:
[Not specified]
Funded by:
[Not specified]
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:
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
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
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
Note:
Year
Topic:
Project Management
Document Type:
User Guide
Target Audience:
Project Managers, Stakeholders
Year:
Not specified
Region / City:
Not specified
Topic:
Construction, Project Completion
Document Type:
Technical guidelines
Author:
Not specified
Target Audience:
Contractors, Consultants, Project Managers
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2021
Region / City:
United States
Topic:
Unmanned Aircraft Systems, Traffic Management
Document Type:
Project Summary
Organization / Institution:
NASA, FAA
Author:
NASA
Target Audience:
Industry professionals, researchers, government agencies
Period of Action:
Oct 2015 – May 2021
Approval Date:
May 2021
Modification Date:
N/A
Year:
2023
Region / City:
[Insert name of jurisdiction]
Subject:
Grant Closeout and Recapture of Unspent Grant Funds
Document Type:
Official Notice
Issuing Organization:
[Insert organization]
Author:
[Insert author name or department]
Target Audience:
Grantees under the Neighborhood Stabilization Program
Action Required:
Submission of specific documentation for grant closeout and fund recapture
Date of Issuance:
[Insert date]
Date of Amendment:
N/A
Expiration Date:
N/A
Year:
2026
Region / City:
United States
Topic:
Energy Research Program Reporting
Document Type:
Instructional Checklist
Agency / Institution:
Advanced Research Projects Agency-Energy (ARPA-E)
Author:
ARPA-E Program Office
Intended Audience:
Grant Recipients and Subrecipients
Reporting Period:
Varies by report type (Quarterly, Annual, Final)
Effective Date:
2026
References:
ePIC Portal, iEdison, DOE Submission Portals
Note:
Year
Institution:
United Tribes Technical College
Organ:
Institutional Review Board (IRB) for Protection of Human Subjects
Document Type:
Protocol Closeout Form
Purpose:
Research Project Closure
Related To:
Human Subjects Research
Required By:
UTTC IRB
Submission Method:
Email to [email protected]
Responsible Party:
Principal Investigator
Includes Fields:
Project Title, IRB Protocol Number, Closeout Date
Includes Reporting On:
Subject Enrollment, Study Completion, Withdrawals, Adverse Events, Protocol Deviations, Amendments
Certification Requirement:
Signature of Principal Investigator
Approval Authority:
UTTC Institutional Review Board