№ lp_1_31429
File format: docx
Character count: 7785
File size: 29 KB
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.
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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
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
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:
2017
Regulation:
EU No 536/2014
Document type:
Template
Topic:
Investigational Medicinal Products (IMP)
Regulatory reference:
Article 62(1) of Regulation (EU) No 536/2014
Manufacturer:
Not specified
Certification authority:
Qualified Person (QP)
Target audience:
Manufacturers, sponsors, regulatory bodies
Purpose:
Harmonisation of batch release certification
Approval date:
Not specified
Modification date:
Not specified
Context:
Template for certification of investigational medicinal products batch release for clinical trials, ensuring compliance with EU regulations on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Year:
2023
Region / city:
EU
Topic:
Medical Device Safety
Document Type:
Checklist
Organization:
European Commission
Author:
European Commission
Target Audience:
Medical device manufacturers
Effective Period:
Ongoing
Approval Date:
2023
Revision Date:
Not specified
Year:
2016
Region / city:
EU
Theme:
Pharmaceutical Regulation
Document Type:
Guideline
Organization:
EFPIA
Author:
Sini Eskola
Target audience:
Regulatory authorities, pharmaceutical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Year
Document type:
Accountability log
Scope:
Clinical investigation site
Subject matter:
Investigational medical devices
Regulatory framework:
EU Regulation 2017/745 on Medical Devices (MDR)
Applicable date:
26 May 2021
Version date:
18 August 2021
Responsible organization:
Kliniska Studier Sverige
Responsible network:
National network for clinical investigations with medical devices within Clinical Studies Sweden
Geographical context:
Sweden
Intended setting:
Clinical investigation site(s)
Signatory role:
Principal Investigator
Source category:
Clinical research documentation
Year:
2023
Region / City:
Portland
Topic:
Clinical Research
Document Type:
Form
Author:
VA Portland Health Care System
Target Audience:
Researchers, Investigators, IRB Members
Period of Action:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Global
Subject:
Clinical trials, Teletrial Model, Investigational Medicinal Product
Document Type:
Standard Operating Procedure (SOP)
Institution:
Teletrial Primary Site Pharmacy
Author:
Not specified
Target Audience:
Clinical trial staff, Teletrial site personnel
Period of validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2019
Region / city:
EU
Theme:
Clinical trials, Genetic modification
Document type:
Application form
Organization / institution:
European Union
Author:
Not specified
Target audience:
Regulatory authorities, developers of medicinal products
Validity period:
Not specified
Approval date:
October 2019
Amendment date:
December 2020
Document type:
Quality Technical Agreement
Subject:
Manufacture, overlabelling, importation, release and distribution of investigational medicinal products
Applicable regulations:
GMP, GDP, Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), ICH Good Clinical Practice, Declaration of Helsinki 1996
Parties:
Sponsor Organisation; Manufacturing Organisation; Importing Organisation
Geographic scope:
Great Britain
Intended use:
Clinical trials
Term:
Up to five years from final signature
Review frequency:
Every five years
Annexes:
Drug products and services; Responsibilities of each Party; Key Contact Persons; List of Subcontractors; Technical Agreement Approval; Version History
Providing organisation:
The Newcastle upon Tyne Hospitals NHS Foundation Trust Quality Assurance Pharmacy Team
Source type:
Contractual regulatory document governing quality responsibilities in clinical research supply chains