№ lp_1_2_61540
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This document outlines the responsibilities and commitments of the principal investigator in conducting a clinical investigation for investigational devices under FDA regulations.
Note:
Year
Subject:
Clinical Research, Investigational Devices
Document Type:
Investigator Agreement
Target Audience:
Clinical Researchers, Investigators
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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
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
Year:
20____
Region / City:
Randall County, Texas
Topic:
Legal Procedure
Document Type:
Motion
Organ / Institution:
Randall County District Court
Author:
[Attorney for Defendant]
Target Audience:
Legal Professionals, Court Officials
Period of Effectiveness:
From the date of approval
Date of Approval:
[DATE OF CASE ASSIGNMENT]
Date of Changes:
None indicated
Context:
This is a legal document requesting the appointment of a private investigator to assist a defendant in preparing a defense in a criminal case.
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
Note:
Year
Document type:
Checklist
Target audience:
Investigators, IRB staff
Context description:
A checklist for investigators and IRB staff to assess and ensure regulatory compliance in clinical and non-clinical research studies.
Year:
2025
Region / City:
Doha, Qatar
Topic:
Human Research Protection
Document Type:
Manual
Institution:
Virginia Commonwealth University
Author:
Huron Consulting Group
Target Audience:
Researchers, Investigators, Staff
Approval Date:
08/07/2025
Modification Date:
Not specified
Period of validity:
Not specified
Note:
Study Summary 1.1 Please provide a brief summary of the study in the table below. A complete description of the study with detailed information should be provided in the body of the protocol. For sections not applicable to the study, mark them as N/A. Study Title Study Design Primary Objective/Purpose Secondary Objective(s)/Purposes Research Intervention(s) ClinicalTrials.gov NCT # Study Population Sample Size Study Duration for individual subjects Study Specific Abbreviations/ Definitions
Background 3.1 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. :
this section should be limited to only information directly related to the research questions and objectives. Do not include your full dissertation proposal. 3.2 Describe any relevant preliminary data (e.g. pilot data).
Procedures Involved 5.1 Describe and explain the study design. 5.2 Please select the methods that will be employed in this study (select all that apply):
☐ Audio/Video Recording ☐ Psychophysiological Recording ☐ Behavioral Interventions ☐ Record Review - Educational ☐ Behavioral Observations and Experimentations ☐ Record Review - Employee ☐ Deception ☐ Record Review- Medical ☐ Focus Groups ☐ Record Review - Other ☐ Interviews ☐ Specimen Collection or Analysis ☐ Investigational Medical Device – (e.g. Medical Mobile Applications) ☐ Surveys and/or Questionnaires ☐Psychometric Testing ☐ Other Social-Behavioral Procedures Provide a description of all research procedures being performed and when they are performed. (Upload any surveys, questionnaires, interview scripts, focus group scripts, debriefing scripts, psychometric tests, stimulus materials, intervention manuals, and data collection forms on the Local Site Documents page in the IRB application.) 5.3 Describe the procedures or interventions that are going to be conducted as part of the research project, but that would have been conducted anyway, even if the research was not occurring (i.e. standard of care procedures, activities that would occur in a classroom). 5.4 Describe the procedures performed to lessen the probability or magnitude of risks of items selected in 5.2.5. 5 If accessing or collecting existing data, describe: The data that will be collected during the study (e.g. demographics, medical history, etc.). Attach the data capture sheet(s) on the Local Site Documents page in the IRB application. How the data will be obtained, including how you have the authority to access the data. The source or location of the data (e.g. USF Epic, TGH Epic, Hillsborough County School records, CANVAS records, publicly available databases, etc.). 5.6 If collecting and/or analyzing biological specimens, describe: How the biological specimens will be or have been collected. How the biological specimens will be stored. How long the biological specimens will be stored. How the biological specimens will be used. The laboratories that will be used. Whether the collected biological specimens will undergo genetic testing. If so, indicate if this study is part of a Genome Wide Association Study (GWAS) and whether the data will be forwarded to the NIH dbGaP. 5.7 If there are plans for long-term follow-up (once all research related procedures are complete), what data will be collected during this period.
Data and Specimen Storage for Future Research 6.1 If data or specimens will be banked for future research studies, describe where the data or specimens will be stored, how long it/they will b:
the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens.