№ lp_1_23807
File format: docx
Character count: 9534
File size: 88 KB
Guidance document for researchers outlining procedures and responsibilities for submitting and reviewing amendments to previously approved human research studies and clinical trials.
Year:
2018
Type of Document:
Guidance notes
Target Audience:
Principal Investigators, Research Ethics Board members
Regulations Referenced:
Tri-Council Policy Statement (TCPS 2), ICH Good Clinical Practice (E6)
Scope:
Research involving human participants, including clinical trials
Approval Authority:
Research Ethics Board (REB)
Submission Requirements:
Electronic submission of amendments, updated consent forms, and relevant documentation
Review Process:
Expedited Review, Full Board Review
Conflict of Interest:
Required declaration for new Principal Investigators
Amendments Covered:
Protocol changes, investigator changes, funding agency changes, study title changes, risk updates
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Country:
Canada
Study Type:
Phase II clinical trial
Treatment Regimen:
Bendamustine-Rituximab combination with concurrent Acalabrutinib
Participants:
62
Centers:
9
Primary Endpoint:
Combined Complete and Very Good Partial Response (CR+VGPR) rates
Secondary Endpoints:
Best overall response (BoR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), Minimal Residual Disease (MRD)
Median Age:
69
Mutation Analysis:
MYD88 89.3%, CXCR4 28.6%, TP53 1.8%
Adverse Events:
Treatment-related adverse events (TRAEs) in 53 participants, 42 Grade 3/4 during combination therapy, 15 Grade 3/4 during monotherapy
Follow-up:
Median 350 days
Data Cut-off:
June 5, 2024
Document Type:
Clinical trial report
Year:
2023
Region / city:
Australia
Topic:
Oncology, Pharmaceuticals
Document Type:
Resubmission
Institution:
Australian Government, Pharmaceutical Benefits Advisory Committee
Author:
AstraZeneca Pty Ltd.
Target Audience:
Healthcare professionals, regulatory bodies
Effective Period:
Ongoing
Approval Date:
November 2021
Date of Changes:
November 2021
Year:
2024
Region / city:
United States
Theme:
Organic agriculture, regulatory processes
Document type:
Government report
Organ / institution:
U.S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS)
Author:
U.S. Department of Agriculture (USDA)
Target audience:
Government agencies, agricultural organizations, organic certifiers, farmers
Period of action:
2024-2027
Approval date:
Pending
Amendment date:
Not specified
Year:
2026
Region / city:
United States
Subject:
Healthcare, Patient Experience, Pediatric Hospitals
Document Type:
Report
Agency / Institution:
Agency for Healthcare Research and Quality (AHRQ)
Author:
Agency for Healthcare Research and Quality (AHRQ)
Target Audience:
Healthcare professionals, hospital administrators, policymakers, researchers
Period of validity:
N/A
Approval date:
October 12, 2022
Date of changes:
N/A
Year:
2024
Region / City:
Lafayette, Indiana
Topic:
Lead and Galvanized Water Service Line Replacement
Document Type:
Notice
Organization / Institution:
Lafayette Water Works
Author:
Steve Moore
Target Audience:
Drinking water consumers, property owners
Action Period:
7 years (estimated)
Approval Date:
November 1, 2024
Date of Changes:
N/A
Context:
A public notice regarding the identification and replacement of galvanized water service lines potentially downstream of lead pipes, outlining health risks, steps for reducing exposure to lead, and replacement options.
Year:
2026
Region / city:
N/A
Topic:
Research protocols review
Document type:
Review form
Organization / institution:
eCompliance
Author:
N/A
Target audience:
Researchers, Institutional Review Boards (IRB)
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Context:
A review form for ongoing research protocols used to update institutional review boards on participant data, protocol deviations, and study status.
Year:
2013
Region / City:
Not specified
Subject:
Developmental Language Disorder (DLD)
Document Type:
Care Pathway
Organization:
Not specified
Author:
Not specified
Target Audience:
Health professionals, therapists, parents, educators
Period of validity:
Not specified
Approval Date:
Not specified
Date of last update:
Not specified
Year:
2023
Region / City:
Cheshire and Merseyside
Topic:
Healthcare, Continuing Care
Document Type:
Procedure Guide
Organization:
NHS Cheshire and Merseyside
Author:
NHS Continuing Healthcare
Target Audience:
Healthcare practitioners, case managers, legal representatives
Period of Validity:
From 1 April 2012 onwards
Approval Date:
January 2023
Date of Amendments:
None specified
Year:
2021
Region / city:
Montana
Topic:
Accounting, Lease Disclosure
Document Type:
Report
Organization:
Statewide Accounting Bureau
Author:
Statewide Accounting Bureau
Target Audience:
State agencies
Period of validity:
Fiscal Year 2021
Approval Date:
May 19, 2021
Date of Changes:
Not specified
Product Name:
VP SpotDot (previously Emprint)
Document Type:
User Manual
Revision:
20150327
Model Number:
VPTT0508-01
Manufacturer:
ViewPlus Technologies, Inc.
Product Description:
Tactile Graphics and Braille Embossing Printer powered by Tiger
Interface:
USB
Print Capabilities:
Full-color ink printing and tactile embossing
Supported Paper Sizes:
A4, US Letter (8.5 x 11 in.), Legal (8.5 x 14 in.), envelopes
Power Supply:
100–240 VAR (±10%), 50/60 Hz (±3%)
Compliance Standards:
FCC Part 15 Class B, EN55022, EN55024, EN61000 series, CISPR22, NMB-003
Intended Audience:
Owners and operators of the VP SpotDot printer
Year:
2024
Region / City:
Priestley College
Topic:
Looked After and Previously Looked After Children
Document Type:
Policy
Organ / Institution:
Priestley College
Author:
Priestley College
Target Audience:
Staff, Governors, and Stakeholders of TCAT Academies
Effective Period:
From approval date (21.6.22) onwards
Approval Date:
21.6.22
Date of Latest Update:
10.10.23
Note:
Date of Submittal
Year:
2025
Region / city:
International
Topic:
Shark conservation, finning regulation
Document type:
Recommendation
Organization / institution:
International Commission for the Conservation of Atlantic Tunas (ICCAT)
Author:
Japan
Target audience:
CPCs (Contracting Parties and Cooperating Non-Contracting Parties)
Period of validity:
Ongoing
Approval date:
2025
Amendment date:
Not specified
Year:
2024
Region / City:
Wabash, Indiana
Subject:
Sanitary and Stormwater Sewer Regulations
Document Type:
Ordinance
Body/Institution:
Wabash City Council
Author:
John Burnsworth, President of the Common Council
Target Audience:
Residents, developers, public utility companies, city officials
Effective Period:
2024
Approval Date:
______ Day of ________, 2024
Amendment Date:
______ Day of ________, 2024
Year:
2026
Organization:
IQNavigator
Audience:
Hiring Manager and Program Office staff
Document Type:
Procedure/Instruction
Scope:
Assignment lifecycle management
Topics:
Assignment edits, contract amendments, onboarding checklist, assignment closure
Effective Date:
2026-02-05
Year:
2023
Region / City:
Geneva
Subject:
Event Data Recorders (EDRs), Vehicle Safety
Document Type:
Working Document
Organization / Institution:
United Nations
Author:
Economic Commission for Europe, Inland Transport Committee, World Forum for Harmonization of Vehicle Regulations
Target Audience:
Vehicle manufacturers, regulatory authorities, safety engineers
Period of Application:
Indefinite
Approval Date:
Not specified
Date of Last Update:
Not specified
Year:
2023–2027
Location:
Royal Borough of Kensington and Chelsea, London
Document Type:
Building Contract
Governing Law:
England
Parties:
The Mayor and Burgesses of the Royal Borough of Kensington and Chelsea; [Contractor]
Contract Framework:
JCT Measured Term Contract 2016, as amended
Contract Scope:
Temporary hoarding and security services for Notting Hill Carnival
Execution:
Deed
Signatories:
Authorized representatives of both parties
Schedules Included:
Schedule of Amendments, Schedule 1–3
Year:
2025
Region / City:
Rogers, Arkansas
Subject:
Development Impact Fees
Document Type:
Ordinance
Organization / Institution:
Rogers City Council
Author:
Rogers Waterworks and Sewer Commission
Target Audience:
City officials, developers, residents
Period of validity:
From October 1, 2025
Approval Date:
July 22, 2025
Date of amendments:
June 16, 2025