№ lp_1_27246
File format: docx
Character count: 2674
File size: 120 KB
Accountability record within clinical research documentation that records receipt, storage, dispensing, return, and disposal of investigational medical devices at clinical investigation sites in accordance with EU MDR requirements.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
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
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:
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
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
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
Note:
Year
Subject:
Clinical Research, Investigational Devices
Document Type:
Investigator Agreement
Target Audience:
Clinical Researchers, Investigators
Year:
2012
Region / City:
Falls Church, VA
Topic:
TRICARE Dental Program, Data Exchange
Document Type:
Interface Control Document (ICD)
Organization / Institution:
DHSS Program Executive Office
Author:
Not specified
Target Audience:
DHSS Program Executive Office, TMA Contract Operations Office
Period of Validity:
Ongoing
Approval Date:
June 7, 2012
Date of Changes:
May 25, 2012
Year:
2004
Region / City:
Falls Church, VA
Topic:
Data Exchange, Health Care Provider Record
Document Type:
Technical Specification
Organization:
EI/DS Program Office
Author:
Mr. Phil Dederer, Mr. Steve Luhrman, Mr. Jeffrey Lopata, Mr. Allen Johnston
Target Audience:
Technical personnel, EI/DS Program Office members, TRICARE Management Activity-Aurora (TMA-Aurora) staff
Effective Period:
Not specified
Approval Date:
May 7, 2004
Revision Date:
Not specified
Year:
2025
Region / City:
European Union
Topic:
Medical Devices
Document Type:
Application Form
Authoring Organization:
Medical Device Coordination Group (MDCG)
Target Audience:
Conformity assessment bodies
Period of Validity:
Ongoing
Approval Date:
January 2025
Amendment Date:
N/A
Year:
2017
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Regulatory Document
Organization / Institution:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Notified Bodies, Conformity Assessment Bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified