№ lp_1_2_19862
File format: docx
Character count: 5204
File size: 4266 KB
Informed consent document for patients outlining the voluntary use, potential risks, duration, costs, and oversight of an experimental medical treatment with an unapproved test article.
Note:
Year
Type of Document:
Informed Consent Form
Target Audience:
Patient or legal representative
Treatment:
Unapproved drug, device, or biologic
Condition:
Serious medical condition without FDA-approved treatments
Duration of Treatment:
Specified per case
Risks:
Potential unknown harms including death or harm to fetus
Costs:
May be billed to patient or insurance
Oversight:
Institutional Review Board (IRB) and FDA
Price: 8 / 10 USD
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Note:
Year
Subject:
Emergency Use Treatment
Document Type:
Informed Consent Form
Year:
2026
Country:
Australia
Type of document:
Application form
Issuing authority:
Therapeutic Goods Administration (TGA)
Intended audience:
Medical practitioners
Purpose:
Application to become an authorised prescriber of unapproved medicines or medical devices
Regulatory reference:
Therapeutic Goods Regulations 1990, Regulation 12B(1B)
Required attachments:
Ethics committee or specialist college approval/declaration (if applicable)
Information collected:
Personal details of medical practitioner, patient consent, product information, prescribing details
Submission method:
Email or fax to TGA
Year:
2026
Region / City:
United States
Theme:
Emergency and Individual Patient Use of Unapproved Drugs
Document Type:
Regulatory Guidance
Agency / Institution:
FDA, BMC/BUMC IRB
Author:
Not specified
Target Audience:
Healthcare professionals, Investigators, Physicians
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
Lackawanna Trail School District
Subject:
School Board Meeting Minutes
Document Type:
Meeting Minutes
Organization / Institution:
Lackawanna Trail School District Board of Education
Author:
Board Members
Target Audience:
Board Members, District Staff, Public
Period of Action:
July 7, 2025
Approval Date:
Not approved
Modification Date:
Not indicated
Year:
2026
Region / City:
Earlham, Iowa
Subject:
Budget Planning and Allocation
Document Type:
Meeting Minutes
Organization / Institution:
Earlham City Council
Author:
Budget Committee
Target Audience:
City Council Members, Local Government Officials
Period of Action:
Fiscal Year 2026
Approval Date:
February 11, 2026
Amendment Date:
N/A
Year:
2025
Region / City:
Andhra Pradesh
Topic:
Urban Development
Document Type:
Government Order
Authority:
Government of Andhra Pradesh
Author:
S. Suresh Kumar, Principal Secretary to Government
Target Audience:
Municipalities, Urban Development Authorities, Government Officials
Effective Period:
From 26-07-2025
Approval Date:
26-07-2025
Amendment Date:
26-07-2025
Year:
2025
Region / City:
N/A
Topic:
Medical Device, Compassionate Use
Document Type:
Worksheet
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Investigators, Designated Reviewers
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Region / City:
Big Pine
Topic:
Board meeting minutes
Document Type:
Meeting minutes
Organization / Institution:
Big Pine Community Services District
Author:
BryAnna Vaughan, Gary Doyel, Walt Sharer, Kent Schlick, Denise Tetrick
Target Audience:
Board members, contractors, administrative staff
Period of Validity:
May 15, 2024
Approval Date:
Not approved
Date of Changes:
May 15, 2024
Contextual Description:
Meeting minutes from the Big Pine Community Services District board meeting held on May 15, 2024.
Year:
2024
Region / City:
Big Pine
Topic:
Community Services District Board Meeting
Document Type:
Meeting Minutes
Organization:
Big Pine Community Services District
Author:
Denise Tetrick
Target Audience:
Board Members, Community Members
Period of Validity:
January 17, 2024
Approval Date:
January 17, 2024
Amendment Date:
None
Year:
2025
Location:
Richford, Vermont, USA
Document type:
Meeting minutes
Governing body:
Town of Richford Selectboard
Chair:
Steinhour
Attendees:
Andy Pond, Kristin Sheperd, Sherry Paquette, Alan Fletcher, Town Clerk Kiley Deuso, Karen Cangelosi, Whitney Benzing, Drew Gingras, Jon Wood, James Kleckan, Mark Jaffee, Robert Wetherby, Gerry Vaisey
Topics covered:
TAP Final Scoping Report, zoning issues, water plant security, road and building maintenance, parks, cemeteries, planning applications, executive session
Decisions made:
Approval of previous minutes, purchase of cameras, term extensions, sending violation letters, permissions for bus shelters, executive session for contractual matters
Meeting start time:
5:00 pm
Meeting end time:
6:20 pm
Submission:
Karen Cangelosi
Year:
2025
Document Type:
Worksheet
Purpose:
Emergency use of unapproved drugs, biologics, or devices
Audience:
Investigators and Designated Reviewers
Regulatory Reference:
FDA IND, 21 CFR §50
Scope:
Life-threatening or severely debilitating conditions
Approval Requirement:
IRB reporting within 5 working days
Consent Requirement:
Informed consent from patient or legally authorized representative, exceptions documented
Certification:
Physician uninvolved in investigation must certify when consent cannot be obtained
Document ID:
HRP-322
Related Documents:
HRP-310, HRP-314, HRP-506
Year:
2024
Region / City:
Big Pine, Inyo County, California, USA
Document Type:
Meeting Minutes
Organization:
Big Pine Community Services District
Attendees:
BryAnna Vaughan, Gary Doyel, Kent Schlick, Breeanna Ralston, Kevin Bigham, Denise Tetrick, Dave Tanksley, Christie Martindale, Jen Roeser
Absent:
Colleen Randolph
Topics Discussed:
Sewer disconnection, budget presentation, public comments, bills and warrants, old and new business, updates on water and sewer system, grants, and regulatory compliance
Next Meeting:
January 15, 2025
Document Status:
Unapproved
Source Type:
Administrative record
Meeting Start Time:
6:00 PM
Meeting Adjournment Time:
8:10 PM
Minutes Prepared By:
Denise Tetrick
Date:
March 20, 2024
Location:
Big Pine Community Services District
Topic:
Board meeting minutes
Document type:
Meeting minutes
Organization:
Big Pine Community Services District
Author:
Denise Tetrick, Administrative Services Manager
Target audience:
Board members, district staff, stakeholders
Approval date:
Pending
Next meeting:
April 17, 2024
Year:
2024
Region / City:
Victoria, Australia
Topic:
Non-emergency patient transport, clinical protocols
Document type:
Clinical Practice Protocols
Author:
Victorian Government, Department of Health
Target audience:
Licensed non-emergency patient transport providers, healthcare services
Period of validity:
August 2024 - June 2025
Approval date:
August 2024
Revision date:
June 30, 2025
Year:
2022
Region / City:
Massachusetts
Topic:
Transportation Services
Document Type:
Contract Appendix
Organization / Institution:
Commonwealth of Massachusetts, EOHHS, HST Office
Author:
Not specified
Target Audience:
Transportation Providers under contract
Effective Period:
From 7/1/22
Approval Date:
Not specified
Revision Date:
Not specified
Jurisdiction:
Victoria, Australia
Legislation reference:
Non-Emergency Patient Transport Regulations 2016 Part 3, Regulations 19–21
Subject:
Clinical competency standards for Non-Emergency Patient Transport staff
Document type:
Official regulatory standard
Issuing authority:
Victorian Government, Department of Health
Place of publication:
Melbourne
Address:
1 Treasury Place, Melbourne
Publication date:
November 2021
Copyright holder:
State of Victoria, Australia
Applicable roles:
Clinical Instructor (CI), Ambulance Transport Attendant (ATA), Patient Transport Officer (PTO)
Training requirements:
Annual skills maintenance training aligned to patient acuity levels
Contact:
[email protected]
Note:
Year
Theme:
Non-Emergency Healthcare Transportation
Document Type:
Policy / Program Information
Organization / Institution:
Aetna Better Health of Ohio, Molina Healthcare
Target Audience:
Medicaid members, Medicare members, MyCare Ohio members, CareSource members
Year:
2015
Region / City:
Maine
Topic:
Non-Emergency Transportation
Document Type:
Policy and Procedure
Organization / Institution:
Maine Department of Health and Human Services
Author:
MaineCare Services
Target Audience:
MaineCare Members, Transportation Providers, Brokers
Effective Period:
From 4/5/2015
Approval Date:
4/5/2015
Date of Last Update:
4/5/2015
Year:
2024
Region / City:
Victoria, Australia
Topic:
Non-Emergency Patient Transport Licence Renewal
Document Type:
Checklist
Organization:
Department of Health, Victoria
Author:
Victorian Government, Department of Health
Target Audience:
NEPT service providers and applicants
Validity Period:
Ongoing
Approval Date:
February 2024
Last Modified:
February 2024
Year:
2023
Region / City:
Victoria, Australia
Subject:
Non-Emergency Patient Transport (NEPT) licensing
Document type:
Form
Organization:
Department of Health, Victoria
Author:
Victorian Government
Target audience:
Individuals or corporate bodies applying for a Non-Emergency Patient Transport license
Effective period:
Indefinite, subject to updates
Approval date:
September 2023
Date of amendments:
N/A