№ lp_1_2_39343
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This document is an application for a substantial modification (SM) to a clinical trial, providing detailed updates on regulatory changes, document revisions, and trial information, in accordance with EU regulations and guidance.
Year:
2024
Region / City:
EU
Subject:
Clinical Trial
Document Type:
Application
Author:
Applicant Name
Target Audience:
Regulatory authorities
Period of validity:
From March 19, 2024
Date of approval:
March 19, 2024
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2018
Region / City:
San Joaquin Valley, California
Topic:
Healthcare, Agricultural Industry
Document Type:
Report
Organization:
Diringer and Associates, California Rural Legal Assistance Foundation
Author:
Joel Diringer, JD, MPH, Noe Paramo, JD
Target Audience:
Agricultural workers, policymakers, public health professionals
Period of Action:
April 2018
Date of Approval:
April 2018
Date of Changes:
N/A
Contextual Description:
A report examining the impact of Medi-Cal expansion on farmworkers in San Joaquin Valley, addressing both health coverage and economic consequences for agricultural employers.
Note:
Year
Theme:
Accreditation
Document Type:
Worksheet
Organization / Institution:
Higher Learning Commission (HLC)
Target Audience:
Institutions seeking accreditation
Year:
2024
Region / City:
California
Subject:
Environmental Defense Fund, compensation, gas revenue requirement
Document Type:
Decision
Authority / Institution:
California Public Utilities Commission
Author:
Environmental Defense Fund
Target Audience:
Public utilities stakeholders, environmental advocacy groups, regulatory bodies
Period of Effectiveness:
January 1, 2024
Approval Date:
December 23, 2024
Date of Last Amendment:
N/A
Year:
2026
Region / City:
California
Topic:
Gas Systems, Public Utilities
Document Type:
Decision
Agency / Organization:
Public Utilities Commission of the State of California
Author:
Not specified
Target Audience:
Not specified
Effective Period:
Not specified
Approval Date:
December 21, 2023
Modification Date:
Not specified
Date:
01-01-1900
Subject:
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
Sponsor:
Sponsor Name
EU Trial number:
Trial Number
Application number:
SM-x
Protocol Number:
Protocol Number/Acronym
Protocol Title:
Protocol Title
Document version:
v2.0
Regulation compliance:
Regulation (EU) No 536/2014
Document type:
Substantial Modification Application
Target audience:
Regulatory authorities
Submission portal:
CTIS
Modification scope:
Substantial and non-substantial changes described
Document components:
Protocol, IB, IMPD, SoC, track-changes version
Date of last update:
01-01-1900
Year:
2024
Region/City:
Texas
Theme:
Floodplain management
Document Type:
Template
Organ/Institution:
Texas Water Development Board
Author:
Texas Water Development Board
Target Audience:
Communities participating in the NFIP
Period of Validity:
Indefinite
Approval Date:
April 2024
Modification Date:
April 2024
Year:
2013
Region / City:
New Zealand
Subject:
Financial Markets Conduct Act, disclosure requirements
Document Type:
Regulatory form
Agency / Institution:
Licensed market operator, listed issuer
Author:
Not specified
Target Audience:
Entities with substantial holdings in financial products
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2021
Region / City:
Ireland
Subject:
Medical Devices, Clinical Investigation
Document Type:
Notification
Author:
Health Products Regulatory Authority (HPRA)
Target Audience:
Sponsors of clinical investigations
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Note:
Year
Subject:
Clinical Trial Application
Document Type:
Protocol
Year:
2024
Region / City:
European Union
Topic:
Clinical Trial Modifications
Document Type:
Application
Organization / Institution:
European Medicines Agency (EMA)
Author:
Applicant
Target Audience:
Regulatory Authorities
Period of Validity:
Ongoing
Approval Date:
March 19, 2024
Modification Date:
January 1, 1900
Project:
[name of project]
Type:
Project Management Document
Sector:
[Country/Sector Context]
Objective:
Define stakeholder engagement program including consultation and grievance mechanisms
Implementing Agency:
[name of implementing agency]
Target Groups:
Affected parties, other interested parties, vulnerable/disadvantaged groups
Framework:
World Bank Environment and Social Framework (ESF)
Components:
[list components and short description]
Locations:
[list locations]
Project Stage:
Preparation and Implementation
Mechanisms:
Grievance Mechanism (GM)
Budget:
[insert total estimated amount]
Year:
2026
Region / City:
Community-based
Subject:
Disaster Management
Document Type:
Template
Author:
Federal Emergency Management Agency (FEMA)
Target Audience:
Local government officials, community planners, disaster management coordinators
Period of Action:
Ongoing, as required for CRS credit
Approval Date:
2026-02-01
Date of Changes:
None
Year:
2026
Region / City:
Hong Kong
Topic:
Securities and Futures Regulation
Document Type:
Notification Form
Organization:
Securities and Futures Commission
Author:
Securities and Futures Commission
Target Audience:
Licensed Corporations, Registered Institutions, Substantial Shareholders
Period of Validity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Year
Contextual Description:
Document is a form for requesting approval for substantive changes in academic programs from an accrediting body.
Year:
2014
Organization:
U.S. Department of Veterans Affairs
Office:
Strategic Acquisition Center
Type of Document:
Request for Information (RFI) Amendment
Solicitation Number:
VA119-14-I-0190
Amendment Number:
A00001
Response Deadline:
June 27, 2014, 12:00 PM EST
Contact Person:
Lance Belcher
Contact Email:
[email protected]
Additional Contact:
Shirelle Taliaferro, [email protected]
Survey Management:
Monterey Consultants, Inc.
Survey URL:
www.mcix.com/ECOMM
Location of Performance:
Fredericksburg, VA
Year:
2017
Region / City:
North Little Rock, AR, USA
Type of Document:
Contract Amendment / Modification
Administered By:
Department of Veterans Affairs, Chief, A&MM (90C/NLR)
Issued By:
Department of Veterans Affairs, Central Arkansas Veterans HCS
Contract Number:
598-17-105
Solicitation Number:
VA256-17-B-0485
Effective Date:
08-25-2017
Purpose:
Add specifications and drawings, update bid schedule
Project Title:
Correct Legionella Problems with Modifications to the Water Distribution System
Delivery Schedule:
See attached documents
Contractor:
[Name not specified in the document]
Year:
2013
Region / City:
Hines, IL, United States
Document Type:
Contract Amendment / Modification
Issuing Agency:
Department of Veterans Affairs
Contracting Officer:
Patricia Gibson-Anderson
Contractor:
Not specified
Effective Date:
August 19, 2013
Proposals Due Date:
September 11, 2013
Subject:
Great Lakes TCA Site Visit Responses and Documentation
Attached Documents:
Questions and answers from TCA site visit August 30, 2013; TCA May–July 2013; TCA detailed formulary; 1-dimensional barcode
Year:
2017
Region / City:
Eatontown, NJ
Subject:
Technology Acquisition
Document Type:
Performance Work Statement (PWS)
Organization / Institution:
Department of Veterans Affairs
Author:
Not specified
Target Audience:
Contractors and vendors in technology and IT services
Period of Validity:
Not specified
Approval Date:
May 19, 2017
Date of Changes:
Not specified
End Date:
Not specified
Additional Information:
Task Order PWS Version 1.0
Year:
2023
Region / city:
Durham
Topic:
Public Rights of Way, Footpath Diversion
Document Type:
Order
Issuing Authority:
Secretary of State for Environment, Food and Rural Affairs
Author:
Claire Tregembo BA(Hons) MIPROW
Target Audience:
Local Authorities, Stakeholders in Urban Planning, Public Rights of Way Users
Effective Period:
Not specified
Approval Date:
16 January 2026
Modification Date:
17 November 2023