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This document is a checklist intended to guide the creation and maintenance of a regulatory binder for non-clinical human subject research conducted under NIMH funding, ensuring compliance with institutional, state, and federal regulations.
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
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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 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:
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
Note:
Year
Subject:
Investigational Product Management
Document Type:
Standard Operating Procedure
Institution:
National Institutes of Health
Target Audience:
Principal Investigator, Study Team Members
Note:
Year
Target Audience:
Principal Investigator and study team members who are delegated to manage investigational products
Prepared by:
Office of Non-clinical and Clinical Compliance, Pharmaceutical and Medical Devices Agency
Organization:
Pharmaceutical and Medical Devices Agency
Country:
Japan
Date of preparation:
January 26, 2017
Version:
1.0
Subject area:
Medical devices regulation
Topic:
Non-clinical studies
Document type:
Regulatory guidance
Inspection type:
Document-based conformity inspection
Legal basis:
Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Target materials:
Supporting data and documents for approval applications
Scope:
Non-clinical studies of medical devices
Intended users:
Applicants for medical device approval and inspection personnel
Year:
2023
Note:
Region / City
Topic:
Research Protocol
Document Type:
Template
Organization / Institution:
DF/HCC
Target Audience:
Investigators, Research Institutions
Note:
Year
Year:
2020
Region / city:
Colorado
Topic:
Behavioral Health
Document Type:
Award Nomination
Organization / Institution:
Colorado Behavioral Healthcare Council (CBHC)
Author:
CBHC
Target Audience:
Community Behavioral Health Organizations
Period of Validity:
Until award announcement
Approval Date:
2020
Date of Changes:
N/A
Year:
2026
Region / City:
Bedford, Luton
Theme:
Healthcare, Sexual Health, Substance Use
Document Type:
Freedom of Information Request
Organization / Institution:
Bedfordshire Hospitals NHS Foundation Trust
Author:
FOI Officer
Target Audience:
Healthcare professionals, policy makers, and researchers
Period of Action:
Not specified
Approval Date:
02/02/2026
Date of Changes:
None
Year:
2023
Region / City:
Ireland
Theme:
Digital Mental Health and Wellbeing Programmes
Document Type:
Referral Form
Organization / Institution:
ISPCC
Author:
ISPCC
Target Audience:
Non-clinical referrers (parents, carers, and teachers)
Effective Period:
Ongoing
Approval Date:
Not specified
Revision Date:
Not specified
Note:
Contextual Description
Year:
2026
Organization:
NHS Professionals
Type of document:
Request Form
Target audience:
Hospital and Trust staff
Location:
United Kingdom
Departments:
Various wards and care groups
Required approvals:
Finance Manager verification, Non-Clinical Consultant review
Fields included:
Contact details, placement dates, hours, working pattern, staff number, system knowledge, assignment code, job description attachment, CV review, interview requirement, DBS requirement
Purpose:
Requesting non-clinical staff placement
Program Name:
Click or tap here to enter text
Year:
2025
Organization:
American Physical Therapy Association (APTA)
Document Type:
Faculty Qualifications Chart
Target Audience:
Program administrators and faculty members
Last Updated:
07/07/2025
Contact:
[email protected]
Instructions Included:
Yes
Data Fields:
Faculty Name, Academic Credentials, Certifications/Memberships, Program Responsibilities, Qualifications, Mentor Qualifications, Professional Development
Year:
2024
Region / City:
N/A
Subject:
Dream research, semantic analysis
Document Type:
Research Protocol
Organization / Institution:
DREAMSEMANTICS.ORG
Author:
N/A
Target Audience:
Researchers, professionals in psychology and dream studies
Effective Period:
N/A
Approval Date:
27 December 2024
Date of Changes:
N/A