№ lp_2_1_14684
File format: docx
Character count: 3453
File size: 17 KB
Clinical trial document detailing monitoring, safety oversight, and reporting procedures for a device with 510K approval or non-significant risk across multiple institutions.
Year:
2026
Region / City:
United States
Type of document:
Clinical trial protocol section
Institution:
University of Colorado Cancer Center
Responsible party:
Sponsor investigator
Oversight committee:
Data and Safety Monitoring Committee (DSMC)
Monitoring scope:
Adverse events, unanticipated problems, protocol compliance, data quality
Reporting requirements:
IRB, local and federal authorities
Frequency of reporting:
Every six or twelve months
Auditing:
Internal audits, independent auditors, regulatory authorities
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Jurisdiction:
Canada
Authority:
Health Canada
Directorate:
Medical Devices Directorate
Document type:
Regulatory guidance and administrative instructions
Regulatory framework:
Medical Devices Regulations
Regulations issued:
July 1998
Subject matter:
Amendments for non-significant additions or deletions of catalogue or model numbers
Application scope:
Sections 28 to 31 and Section 34 of the Medical Devices Regulations
Exclusions:
Private Label licences
Submission requirements:
Fax-back form with copy of page 1 of the applicable licence
Processing timeframe:
7 calendar days from receipt
Authorization effect:
Amended licence authorizes sale of listed devices and catalogue numbers
Related guidance:
Guidance for the Interpretation of Significant Change; Guidance for the Interpretation of Sections 28 to 31
Administrative source:
Medical Devices Directorate, Health Canada
Year:
2017
Organization:
European Securities and Markets Authority (ESMA)
Document type:
Consultation response form
Region/Country:
European Union
Target audience:
Administrators, contributors, and users of benchmarks
Submission deadline:
30 November 2017
Affiliated organizations:
Global Financial Markets Association (GFMA), International Swaps and Derivatives Association (ISDA), FIA
Sector:
Financial services / Banking
Legal framework:
Benchmarks Regulation (BMR)
Year:
2026
Region / City:
Not specified
Topic:
AV Asynchrony Detection
Document Type:
Research Results
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Audiologists, Psychologists
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2025
Issuing office:
Office of Research Oversight
Organization:
U.S. Department of Veterans Affairs
Administration:
Veterans Health Administration
Document type:
Compliance checklist
Subject area:
Laboratory animal welfare
Regulatory framework:
Animal Welfare Act Regulations, PHS Policy on Humane Care and Use of Animals, VHA Directives
Oversight bodies referenced:
IACUC, ORO, NIH OLAW, USDA APHIS
Scope:
VA research involving live vertebrate animals
Intended users:
VA research facilities and IACUCs
Date of issue:
July 25, 2025
Contact information:
ORO Research Safety and Animal Welfare ([email protected]
Note:
)
Year:
2021
Region / City:
International
Topic:
Oversight activities in aerospace quality management
Document Type:
Guidelines
Organization:
International Aerospace Quality Group (IAQG)
Author:
IAQG Oversight Committee
Target Audience:
Aerospace certification bodies, auditors, and quality management professionals
Effective Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
Washington State
Theme:
Legislative Task Force Meeting
Document Type:
Meeting Agenda
Organization / Institution:
Department of Social and Health Services (DSHS)
Author:
Babs Roberts, Senior Advisor, Programs & Policy, Economic Justice Team
Target Audience:
Task Force Members, Public
Period of Effect:
August 21, 2025
Approval Date:
August 21, 2025
Date of Amendments:
None
Note:
Year
Year:
2026
Region/City:
United States
Topic:
Multifamily Housing Management
Document Type:
Form
Organization/Institution:
HUD
Author:
HUD
Target Audience:
HUD staff, Performance Based Contract Administrators, Traditional Contract Administrators, Mortgagees
Effective Period:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Organization:
Office for Nuclear Regulation
Document type:
Technical Assessment Guide
Issue number:
2
Publication date:
May 2024
Next major review date:
May 2027
Document reference:
CNS-TAST-GD-4.3
Record reference number:
2017/106068
Professional lead:
Protective Security
Author:
Deputy Professional Lead
Approved by:
Professional Lead – Protective Security
Regulatory framework:
Nuclear Industries Security Regulations 2003
Related principles:
Security Assessment Principles; Fundamental Security Principles; SyDP 4.3; FSyP 4
Scope:
Oversight of suppliers of items or services of nuclear security significance
Target audience:
ONR inspectors
Revision history:
Periodic fit for purpose review
Note:
Year
Document Type:
Clinical Research Delegation Log
Author:
Principal Investigator / Investigator of Record
Target Audience:
Research Staff
Year:
2023
Region / City:
Birmingham
Theme:
Clinical Research, Medical Oversight
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
University of Birmingham
Author:
Not specified
Target Audience:
Clinical researchers, healthcare professionals
Period of validity:
From the effective date
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2019
Region / city:
United States
Topic:
Cybersecurity, Military Health System
Document type:
Memorandum
Agency / institution:
Defense Health Agency
Author:
Ronald J. Place
Target audience:
Department of Defense officials, military healthcare personnel
Effective period:
2019–2029
Approval date:
2019
Date of amendments:
None
Note:
Year
Topic:
Conflict of Interest, Commitment Management
Document Type:
Management Plan
Organization:
University of Illinois
Author:
Professor XYZ
Target Audience:
University Faculty and Administration
Period of Validity:
Annual
Year:
2022
Region / City:
N/A
Topic:
VA Informed Consent Addendum, NCI CIRB, Boilerplate Language Revision
Document Type:
Guidance
Organization / Institution:
Department of Veterans Affairs (VA)
Author:
ORD, Office of Research Oversight (ORO), NCI CIRB
Target Audience:
VA Facilities, Research Community
Effective Period:
N/A
Approval Date:
April 6, 2022
Date of Updates:
May 12, 2022
Contextual description:
Guidance document on revisions to VA boilerplate language for NCI studies overseen by the NCI CIRB, detailing required actions for VA Facilities.
Note:
Year
Topic:
Human Research, IRB Oversight
Document Type:
Guidance
Target Audience:
Investigators conducting Human Research
Contextual description:
A guidance document for investigators conducting human research, outlining obligations and procedures for IRB oversight and approval.
Year:
2023
Region / City:
Geneva
Topic:
Internal Oversight, Audit, Risk Management
Document Type:
Annual Report
Organization / Institution:
World Meteorological Organization
Author:
Secretary-General
Target Audience:
WMO Management, External Oversight Bodies
Period of Validity:
2023
Approval Date:
30 May 2024
Date of Amendments:
N/A
Year:
2025
Region / City:
Fort Eustis, Virginia
Topic:
Acquisition Management
Document Type:
Pamphlet
Organization / Institution:
U.S. Army Training and Doctrine Command
Author:
David J. Francis
Target Audience:
U.S. Army personnel involved in acquisition management
Period of Validity:
2025 and onward
Approval Date:
16 May 2025
Amendment Date:
N/A
Effective Date:
January 1, 2026
Chapter:
0308
Document Type:
Manual
Region / City:
United States
Thematic Focus:
Nuclear Reactor Security
Institution:
U.S. Nuclear Regulatory Commission (NRC)
Target Audience:
NRC licensees, nuclear reactor operators, security personnel
Date Approved:
January 1, 2026