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Administrative regulatory checklist outlining criteria and documentation requirements for IRB risk determination in research involving abbreviated IDE device studies.
Document Type:
Institutional Review Board (IRB) checklist
Subject:
Criteria for approval of research involving an abbreviated Investigational Device Exemption (IDE)
Related Document:
HRP-314 - WORKSHEET - Criteria for Approval
Applicable To:
IRB Chairs, Vice Chairs, designees, Research Compliance Administrators
Purpose:
Documentation of regulatory determinations and protocol-specific findings
Scope:
Initial reviews, modifications, and continuing reviews with changed determinations
Responsible Office:
IRB Office
Key Topics:
Significant Risk Device Study; Non-Significant Risk Device Study; Risk determination rationale
Regulatory Basis:
Applicable federal regulations governing investigational device studies
Record Retention:
Maintained in the protocol file
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / city:
United States
Topic:
Clinical research, FDA IND/IDE, Regulatory compliance
Document type:
Checklist
Organization / institution:
National Institute of Mental Health (NIMH)
Author:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2019
Region / city:
USA
Topic:
Medical Device Submissions
Document Type:
Instructional Guide
Organization:
FDA (Food and Drug Administration)
Author:
FDA
Target Audience:
Medical Device Manufacturers, Regulatory Affairs Professionals
Action Period:
Since January 1, 2013
Approval Date:
December 13, 2019
Amendment Date:
Not specified
Year:
Not specified
Platform:
Intel Edison
Development Environment:
Arduino IDE 1.6.5
Programming Language:
Arduino (C/C++ based)
Network Configuration:
Custom HTTP port 1000
Referenced Examples:
WiFiWebServer Arduino example
Hardware Inputs:
Digital pins 2, 4, 6, 8
Primary Functionality:
Webpage hosting with background computations
Port Restrictions:
Avoid ports 22, 23, 80, 443
Update Mechanism:
Polling (with suggested interrupt-based improvement)
Type of Document:
Technical implementation notes
Year:
2026
Topic:
Programming, Debugging, IDE Usage
Document Type:
FAQ Guide
Organization:
HackerEarth
Target Audience:
Programmers, Developers, Coding Contest Participants
Document URL:
https://www.hackerearth.com/docs/wiki/developers/solution-guide/
Context:
FAQ source explaining common runtime errors, compilation versus submission differences, and IDE troubleshooting tips for programmers.
Title:
Programming Worksheet on Syntax Highlighting, Prettyprint Formatting, and IDE Features for GCSE Programming Study
Subject:
Computer Science
Topic:
Syntax Highlighting, Code Formatting, Integrated Development Environments
Educational Level:
GCSE
Document Type:
Programming Worksheet
Structure:
Multi-task exercise sheet
Tasks Included:
Syntax highlighting analysis, code formatting (prettyprint), IDE feature comparison, code translation and testing
Programming Languages Mentioned:
Pseudocode, C#
Key Concepts:
Variables, strings, keywords, code readability, debugging features
Programming Tools Referenced:
IDE code editor features
Student Activities:
Code analysis, explanation questions, table completion, practical IDE testing, screenshots of IDE functionality
Year:
2017
Region / City:
Ide, Devon, United Kingdom
Organisation:
Ide Parish Council
Related Site:
Weir Meadow
Document Type:
Terms of Reference
Approval Date:
19 July 2017
Version:
v.2
Working Group:
Weir Meadow Working Group (WMWG)
Subject:
Development and management planning for a village sports and recreational facility
Associated Plan:
Ide Neighbourhood Plan (Policy IDE05)
Proposed Funding Sources:
Community Infrastructure Levy (CIL), National Lottery, local fundraising, Sport England, Football Association
Membership Limit:
Maximum 12 members including at least one Parish Councillor
Meeting Frequency:
Every two months after 6pm
Initial Mandate Period:
18 months
Year:
2025
Region / City:
Ide
Theme:
Community Orchard Management
Document Type:
Meeting Minutes
Organization / Institution:
Ide Parish Council
Author:
Mark Thomas (Chair)
Target Audience:
Members of Ide Community Orchard Management Group, local community
Period of Action:
November 2025
Approval Date:
27 November 2025
Date of Changes:
N/A
Year:
1989
Region / city:
Munich
Subject:
Electrical Engineering
Document Type:
Seminar Paper
Author:
Analog Devices
Target Audience:
Engineers, researchers in electrical power
Approval Date:
1989
Date of Changes:
N/A
Year:
2018
Region / City:
Philadelphia
Subject:
Information Technology, Project Management
Document Type:
Course Description
Organization / Institution:
Community College of Philadelphia
Author:
Barbara Anne Hearn
Target Audience:
Students pursuing a career in IT Project Management
Period of Validity:
Fall 2019 and onward
Approval Date:
November 28, 2018 (updated February 13, 2019)
Date of Changes:
February 13, 2019
Year:
2010
Region / City:
Kumasi
Theme:
Land administration, resettlement
Document type:
Final report
Organization:
Ministry of Lands and Natural Resources (MLNR), Government of Ghana
Author:
Praisel Consulting Limited
Target Audience:
Government agencies, World Bank, stakeholders involved in land administration and resettlement
Effective period:
2010-2011
Approval date:
October 2010
Date of amendments:
Not specified
Document type:
Submission form
Subject:
Abbreviated submission of medicinal products
Jurisdiction:
Scotland
Regulatory framework:
Freedom of Information (Scotland) Act 2002
Intended authority:
Scottish Medicines Consortium
Submission format:
Electronic
Confidentiality classification:
Commercial-in-Confidence and Academic-in-Confidence
Applicable sector:
Healthcare and pharmaceuticals
Target submitters:
Pharmaceutical companies
Review scope:
NHSScotland
Date referenced:
September 2024
Year:
1993-1995
Region / City:
California
Theme:
Environmental Science, Communications, Media
Document Type:
Curriculum Vitae
Organization / Institution:
California State University
Author:
Gregory M. Popejoy
Target Audience:
General Public, Academic Professionals
Effective Period:
2008-present
Approval Date:
1/20
Year:
2025
Region / City:
Philadelphia, PA
Field:
Health Studies, Recreational Therapy
Document Type:
CV
Organization / Institution:
Temple University
Author:
Heather R. Porter, PhD, CTRS, FDRT
Target Audience:
Academics, Researchers, Healthcare professionals
Period of Action:
From 1992–Present
Date of Approval:
April 2025
Date of Changes:
N/A
Note:
Year
Theme:
Medical Emergency, CPR, AED
Document Type:
Emergency Response Plan
Organization:
School
Target Audience:
School staff
Non-Emergency Responsibilities:
School nurse
Year:
1989
Region / City:
Munich
Topic:
Analog Design
Document Type:
Seminar Paper
Institution:
Analog Devices GmbH
Author:
Don Lancaster, A. Grütz, H. Huneus
Target Audience:
Electrical Engineers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Date
Faculty:
Faculty of Medicine
Current Affiliations:
Health Authority:
Current Rank:
Since:
Note:
Date
Year:
2018
Region / City:
Lusaka
Subject:
Resettlement Action Plan
Document Type:
Report
Organization:
Ministry of Water Development, Sanitation and Environmental Protection
Author:
Litumelo Mate, Pilila Chongo
Target Audience:
Project Affected Persons, Government Agencies, Stakeholders
Effective Period:
2018
Approval Date:
10-11-2018
Date of Changes:
Not specified
Year:
2023
Region / City:
Not specified
Topic:
Health research, COVID-19 trial
Document Type:
Research report, supplementary material
Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, health professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified