№ lp_1_31428
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This document is a template for recording and tracking adverse events (AEs) in research studies, providing a structure for site monitors, principal investigators, and study teams.
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
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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
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
Year:
2019
Region / city:
OECD
Topic:
Adverse Outcome Pathway, oxidative stress, brain development, neurotoxicity
Document Type:
External Review Report
Author:
OECD EAGMST review manager
Target Audience:
Scientific community, regulators, policymakers
Period of validity:
Not specified
Approval Date:
June 2018
Date of revisions:
17 March 2020
Year:
2024
Region / city:
UK
Topic:
Climate change, extreme weather, workplace safety
Document type:
Policy document
Organization / institution:
UNISON, TUC
Author:
UNISON
Target audience:
Trade union representatives, employers, workers
Period of validity:
2024–2025
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Year:
2003
Region / City:
Mount Sinai Hospital
Subject:
Clinical Research
Document Type:
Guideline
Organization / Institution:
Mount Sinai Hospital REB
Author:
REB Chair
Target Audience:
Clinical Investigators, Research Staff
Effective Period:
Ongoing
Approval Date:
November 6, 2003
Revision Date:
July 8, 2015
Year:
2026
Region / City:
Boston, MA
Topic:
Clinical Research, Adverse Event Reporting
Document Type:
Form
Author:
BU Medical Campus
Target Audience:
Clinical research staff
Period of validity:
Ongoing
Approval Date:
2026-01-01
Date of Changes:
Not specified
Year:
2019
Region / City:
International
Subject:
Medical device adverse event reporting
Document Type:
Proposed document
Organ / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity:
Not specified
Approval date:
27th June 2019
Date of Changes:
Not specified
Year:
2020
Region / City:
International
Topic:
Medical device regulation
Document Type:
Final Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, medical device manufacturers, healthcare providers
Period of Validity:
Not specified
Approval Date:
18 March 2020
Date of Changes:
Not specified
Note:
Year
Theme:
Healthcare, Medication Safety, Adverse Drug Event Prevention
Document Type:
Program Evaluation Report
Organization / Institution:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
Healthcare Providers, Medicare Beneficiaries, Policymakers
Year:
2022
Region / City:
N/A
Topic:
Adverse Reaction Tracking, Drug Allergy Management
Document Type:
User Manual
Institution:
Department of Veterans Affairs
Author:
N/A
Target Audience:
Healthcare professionals in the Veterans Health Administration
Period of Validity:
N/A
Approval Date:
September 2022
Date of Amendments:
N/A
Year:
2025
Region / City:
United States
Subject:
Serious Adverse Event Reporting
Document Type:
Form
Organization / Institution:
National Cancer Institute (NCI)
Author:
National Cancer Institute
Target Audience:
Clinical Investigators, Medical Monitors, Research Staff
Effective Period:
Ongoing
Approval Date:
09/04/2025
Modification Date:
10/01/2024