№ lp_1_2_59292
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This checklist is intended to help track regulatory documents for clinical research studies under FDA IND/IDE and includes guidelines for creating a regulatory binder.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
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
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
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
Study name:
Abbreviated Title
IND number:
XXXXXX
Regulatory framework:
21 CFR Part 312
Jurisdiction:
United States
Document type:
Sponsor obligation transfer agreement
Transferor:
XYZ Co.
Transferee:
UTSW Medical Center
Involved authorities:
Food and Drug Administration; Drug Enforcement Administration
Scope:
Allocation of sponsor responsibilities for an Investigational New Drug
Signatories:
Current IND Sponsor; New Sponsor
Course Code:
IND 299
Module:
Module Two
Document Type:
Assignment Guidelines and Rubric
Academic Program:
Bachelor of Arts in General Studies (BA.GS)
Assignment Title:
Milestone One
Subject:
SMART Goal and Strategy Paper
Audience:
Students enrolled in the BA.GS degree program
Purpose:
Articulation of career and personal goals related to completion of the BA.GS degree
Submission Format:
1–2 page Microsoft Word document
Formatting Requirements:
Double spacing, 12-point Times New Roman font, one-inch margins
Evaluation Criteria:
Specific Goal; Measure; Attain; Relevance; Time Frame; Articulation of Response
Total Points:
100
Document Type:
Regulatory submission outline
Subject Area:
Clinical research regulation
Regulatory Framework:
U.S. Food and Drug Administration Investigational New Drug (IND) process
Applicable Regulation:
21 CFR 312.23
Institutional Context:
Sponsor-Investigator IND submissions
Primary Topic:
Structure and required information for an initial IND application
Sections Included:
Introduction; General Investigational Plan; Investigator Brochure; Proposed Clinical Research; Chemistry, Manufacturing and Control Information; Pharmacology and Toxicology Information; Previous Human Experience; Additional Information; Appendix
Drug Information Elements:
Active ingredients, pharmacological class, structural formula, dosage formulation, route of administration
Clinical Research Elements:
Objectives, study duration, investigational plan, subject numbers, treatment evaluation approach
Risk Information:
Drug-related risks based on toxicology and prior studies
Manufacturing Information:
Drug substance, drug product, placebo product, labeling
Supporting Materials:
References, clinical protocols, informed consent documents, letters of authorization
Geographic Jurisdiction:
United States
Intended Participants:
Sponsor-investigators and clinical research institutions
Associated Authority:
U.S. Food and Drug Administration
Year:
2025
Region / City:
New Delhi, India
Subject:
Accounting for contracts referencing nature-dependent electricity
Document Type:
Letter / Official Comments
Organization:
Institute of Chartered Accountants of India (ICAI)
Author:
CA Gaurav Singhal
Target Audience:
Accounting Standards Board
Period of Applicability:
Ind AS 109 and Ind AS 107 amendments
Date of Submission:
06.05.2025
Topics Covered:
Scope clarification, hedge accounting, transition approach, net purchaser test, enhanced disclosures, IFRS convergence
Year:
2026
Region / City:
Not specified
Document Type:
Standards of Care
Institution:
Not specified
Author:
Not specified
Target Audience:
Healthcare professionals involved in cancer management
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Topic:
Regulatory compliance, human subject research
Document type:
Checklist
Organization / Institution:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Year:
Not specified
Region / City:
Not specified
Topic:
Adverse events tracking in clinical studies
Document Type:
Template
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Site Monitors, Principal Investigators, study team members
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Year:
2023
Region / City:
Not specified
Topic:
Clinical trial procedures, data management
Document type:
Manual
Organization / Institution:
National Institute of Mental Health (NIMH)
Author:
Not specified
Target audience:
Principal Investigator, study team members
Effective period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Note:
Year
Subject:
Concomitant medications tracking
Document Type:
Template
Organization / Institution:
NIMH
Target Audience:
Principal Investigators, study team members
Year:
2023
Region / City:
United States
Topic:
Clinical trials, Regulatory documentation
Document type:
Checklist
Organization / Institution:
NIMH
Author:
NIMH
Target Audience:
Principal Investigators, study team members
Period of validity:
Ongoing
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
N/A
Topic:
Delegation of authority, Research study management
Document Type:
Template
Organization / Institution:
National Institute of Mental Health (NIMH)
Author:
N/A
Target Audience:
Principal Investigators, Study team members
Period of validity:
N/A
Approval Date:
N/A
Date of amendments:
N/A