№ lp_1_2_19436
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The document provides a detailed guide for preparing a GCP inspection dossier for clinical trials involving Investigational Medicinal Products (IMP) in the UK, outlining the required information and format for submission.
Note:
Year
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
Rwanda
Theme:
Clinical Trials, Good Clinical Practice (GCP) Inspection
Document Type:
Guidelines
Organization / Institution:
Rwanda Food and Drugs Authority (Rwanda FDA)
Author:
Dr. Emile BIENVENU
Target Audience:
Clinical trial regulators, researchers, pharmaceutical professionals
Period of Validity:
Starting from 23/07/2021
Approval Date:
20/05/2021
Date of Revision:
06/01/2023
Year:
2023
Region / city:
USA
Topic:
Clinical Trials, Regulatory Compliance
Document Type:
Guidelines
Institution:
FDA, UTA
Author:
Unknown
Target Audience:
Researchers, Investigators, Clinical Trial Personnel
Effective Period:
Ongoing
Approval Date:
Unknown
Date of Changes:
Unknown
Note:
Contextual Description
Note:
Year
Topic:
Clinical Trials, Good Clinical Practice (GCP)
Document Type:
Checklist
Target Audience:
Clinical Investigators, Research Coordinators, Regulatory Affairs Professionals
Note:
Year
Contextual Description:
International ethical and scientific standards for conducting clinical trials with human subjects, outlining compliance with ICH-GCP Guidelines and additional requirements for NYU’s HRPP.
Note:
Year
Topic:
Cloud Infrastructure, DevOps, Cloud Migration
Document Type:
Resume
Author:
Rithvik Katakamsetty
Target Audience:
Potential Employers, Recruitment Agencies, Cloud Infrastructure Specialists
Year:
2025
Region / City:
Birmingham
Theme:
Clinical Research, Good Clinical Practice (GCP)
Document Type:
Policy
Organ / Institution:
University of Birmingham
Author:
University of Birmingham Research Ethics Committee
Target Audience:
Researchers, Clinical Research Staff
Period of Validity:
Ongoing
Approval Date:
Dec-2025
Date of Changes:
Not specified
Date of Review:
2028, Quarter 4 (Oct-Dec)
Year:
2023
Region / City:
Bentonville, AR, Dallas, TX
Theme:
Data Engineering, Cloud Computing, Data Processing, Cloud Architecture
Document Type:
Resume
Organization:
Walmart, Southern California Edison
Author:
Anusha Reddy
Target Audience:
Hiring Managers, Data Engineering Teams
Period of Activity:
Apr 2025-Present, Mar 2024-Feb 2025
Approval Date:
Not specified
Modification Date:
Not specified
Subject Area:
Clinical research regulation
Document Type:
Regulatory document review worksheet
Related Standards:
ICH GCP Guidelines; 45 CFR 46; 21 CFR 50; 21 CFR 312
Institution / Authority Referenced:
Division of Microbiology and Infectious Diseases (DMID)
Regulatory Authority Referenced:
U.S. Food and Drug Administration (FDA)
Ethics Oversight Reference:
Office for Human Research Protections (OHRP)
Purpose:
Guidance for completion, review, and maintenance of essential regulatory documents for clinical trials
Document Structure:
Tier-based classification of regulatory documents with section and page references
Document Tiers:
Tier 1A; Tier 1B; Tier 2; Closeout Documents
Key Forms Referenced:
Form FDA 1572; Investigator of Record Form; Financial Disclosure Form
Key Roles Referenced:
Principal Investigator; Sub-Investigator; Clinical Site Monitor
Oversight Bodies Referenced:
Institutional Review Board (IRB); OHRP
Applicable Study Types:
DMID-supported IND and IDE clinical studies
Primary Users:
Site staff conducting DMID supported studies; clinical site monitors; DMID contractors
Core Documentation Covered:
Investigator credentials, IRB approvals, informed consent documentation, laboratory certifications, regulatory compliance records
Compliance Focus:
Verification of adherence to Good Clinical Practice and applicable federal regulations
Year:
2024
Region / City:
European Union
Theme:
Health Technology Assessment
Document Type:
Guidance Document
Author:
HTA Coordination Group (HTACG)
Target Audience:
Health Technology Developers, Regulatory Authorities, Medical Researchers
Period of Validity:
Ongoing
Approval Date:
28 November 2024
Date of Last Change:
N/A
Context:
Guidance document for filling in the joint clinical assessment (JCA) dossier template for medicinal products, intended for use by health technology developers and regulatory bodies.
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified
Year:
2023
Region / city:
Singapore
Topic:
Pharmaceutical manufacturing and regulatory requirements
Document type:
Regulatory guideline
Organization:
Health Sciences Authority
Author:
Health Sciences Authority
Target audience:
Pharmaceutical manufacturers, regulatory professionals
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2026
Region / City:
Singapore
Subject:
Pharmaceutical Manufacturing and Regulatory Compliance
Document Type:
Regulatory Guidelines
Organization:
Health Sciences Authority (HSA)
Author:
Health Sciences Authority
Target Audience:
Pharmaceutical Manufacturers, Regulatory Affairs Professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
eCTD, registration dossier, Ministry of Health of Ukraine
Document Type:
Order
Organization / Institution:
Ministry of Health of Ukraine
Target Audience:
Regulatory authorities, applicants for medicinal product registration
Year:
2015
Region / City:
Burlington, NJ
Topic:
Fleet Management Software
Document Type:
User Guide
Organization:
Dossier Systems, Inc.
Author:
Dossier Systems, Inc.
Target Audience:
Fleet Maintenance Managers, IT Administrators
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2022
Region / City:
SADC region
Topic:
Medicine Regulatory Harmonization
Document Type:
Position Paper
Organization / Institution:
SADC Medicines Regulatory Forum (SADC MRF)
Author:
T. Sithole, G. Mahlangu, S. Walker, S. Salek
Target Audience:
Regulatory authorities, pharmaceutical industry, applicants
Period of Validity:
Up to 12 months from issuance of recommendation
Date of Approval:
Not specified
Date of Amendments:
Not specified
Note:
Year
Topic:
Academic Promotion and Tenure
Document Type:
Instructional Guidelines
Organization / Institution:
Auburn University
Target Audience:
Faculty, Department Chairs, University Administrators
Context:
Instructional guidelines for faculty members preparing their dossiers for promotion and tenure evaluations.
Year:
2026
Region / city:
USA, Canada
Topic:
Active substance evaluation
Document Type:
Regulatory document
Organization:
Regulatory Authority (PMRA, EPA)
Author:
Applicant
Target Audience:
Regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified