№ lp_2_3_29319
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This document provides a standardized template for creating clinical trial protocols under DMID sponsorship, with sections for study-specific customization.
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
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Organization:
Division of Microbiology and Infectious Diseases (DMID)
Country:
United States
Subject:
Clinical trial protocol registration requirements
Document Type:
Regulatory and procedural guidelines
Regulatory Framework:
Food and Drug Administration Amendments Act of 2007 (FDAAA); Final Rule; NIH Policy
Registry:
ClinicalTrials.gov
Scope:
Interventional Phase I–IV studies; U.S. FDA-regulated device studies; Pediatric Post-Market Surveillance; DMID-held IND/IDE; DMID-funded studies
Responsible Party:
DMID or IND holder, Principal Investigator, or designated entity under FDAAA
Registration Deadline:
Within 21 days of first subject enrollment
Oversight Roles:
Clinical Project Manager (CPM); SIO
Compliance Activities:
Quality assurance review; data query resolution; periodic protocol review
Division:
Division of Microbiology and Infectious Diseases (DMID)
Study Type:
Non-IND study
Document Type:
Investigator Agreement Form
Purpose:
Protocol Registration Package requirement
Submitting Organization:
Clinical Trials Management Contractor, Technical Resources International, Inc. (TRI)
Investigator Role:
Investigator of Record (IoR)
Required Attachments:
Curriculum Vitae or Statement of Qualifications
Regulatory Framework:
45 CFR Part 46; ICH/GCP
Oversight Bodies:
Institutional Review Board (IRB) or Ethics Committee (EC)
Obligations:
Protocol compliance; informed consent; adverse event reporting; record maintenance; IRB/EC reporting
Signature Requirement:
Investigator of Record signature and date
Year:
2021
Region / city:
United States
Topic:
Pharmacovigilance, Serious Adverse Event Reporting
Document Type:
Reporting Guidelines
Organization / Institution:
DMID-CROMS
Author:
DMID-CROMS Pharmacovigilance Group
Target Audience:
Researchers, Healthcare Professionals, Clinical Trial Investigators
Validity Period:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / city:
US
Subject:
Serious Adverse Event Reporting
Document Type:
Report
Organization:
DMID-CROMS Pharmacovigilance Group (PVG)
Author:
DMID-CROMS
Target audience:
Researchers, healthcare professionals, investigators
Effective period:
Ongoing
Approval date:
Not specified
Amendment date:
Not specified
Organization:
Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID)
Country:
United States
Document Type:
Instructional template and procedural guidance
Subject Area:
Clinical research quality management
Related Standards:
Good Clinical Practice (ICH E6(R2))
Associated Systems:
DMID CROMS (Clinical Research Operations and Management Support), NIAID Clinical Research Management System (N-CRMS)
Intended Users:
Clinical research sites conducting DMID-funded clinical studies or trials
Key Roles Mentioned:
Principal Investigator, DMID Clinical Project Manager (CPM)
Scope:
Development, implementation, and oversight of site Clinical Quality Management Plans
Lifecycle Coverage:
Protocol lifecycle from implementation to data review and documentation
Referenced Authorities:
U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH)
Required Actions:
Version control, documentation review, quality control and quality assurance activities, signatures and filing of CQMP documents
Primary Components:
Protocol and site identification, quality control activities, quality assurance activities, roles and responsibilities, record selection, internal and external data sources
Organization:
Division of Microbiology and Infectious Diseases
Abbreviation:
DMID
Related organization:
National Institute of Allergy and Infectious Diseases
Regulatory framework:
Good Clinical Practice
Subject area:
Clinical trial compliance and protocol deviation reporting
Document type:
Clinical research procedural guidance
Scope:
Identification, documentation, and reporting of protocol deviations in clinical studies
Responsible parties:
Principal Investigator and study site staff
Reporting timeframe:
Within 5 working days of identification or scheduled protocol activity
Applicable systems:
EMMES Internet Data Entry System (IDES / AdvantageEDC)
Oversight bodies:
Institutional Review Board / Independent Ethics Committee
Data management organization:
The Emmes Company, LLC
Submission platforms:
DMID-CROMS website, fax, or e-mail submission system
Documentation requirement:
Completion and maintenance of a DMID Protocol Deviation Form in site regulatory files and subject source documents
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:
2009
Region / city:
South Africa
Subject:
Registration of medicines
Document type:
Guideline
Organization / institution:
South African Health Products Regulatory Authority (SAHPRA)
Author:
Not specified
Target audience:
Applicants for registration of medicines
Period of validity:
Ongoing
Date of approval:
Not specified
Date of amendments:
May 2019
Version:
7
Date of implementation:
June 2011
Deadline for comment:
September 30, 2010
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English
Year:
2015
Region / City:
Thailand
Topic:
eCTD Specification, Regulatory Submission, Pharmaceutical Industry
Document Type:
Technical Specification
Organization / Institution:
Thai FDA
Author:
Thai FDA
Target Audience:
Pharmaceutical companies, regulatory professionals
Validity Period:
Ongoing
Approval Date:
01/12/2015
Date of Changes:
Not specified
Year:
2024
Region / City:
European Union
Topic:
eCTD Implementation
Document Type:
Technical Guide
Organization / Institution:
Health Level Seven (HL7)
Author:
Not specified
Target Audience:
Regulatory bodies, developers, and industry professionals involved in eCTD implementation
Effective Period:
2024
Approval Date:
March 2024
Date of Changes:
March 2024
Version:
1.2
Date:
4th of October 2024
OID:
2.16.840.1.113883.3.989.5.1.1.6.1.2
Document Change History:
2012-2024
Year:
2024
Region / City:
EU
Theme:
Electronic submission, regulatory requirements
Document Type:
Technical Guide
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Regulatory bodies, pharmaceutical industry
Effective Period:
2024 and beyond
Approval Date:
4th October 2024
Modification Date:
N/A
Year:
2001
Type of document:
Regulatory guidance
Scope:
Pharmacokinetics data reporting for nonclinical studies
Applicable region:
International (ICH)
Referenced guidelines:
M4 Organization of the Common Technical Document, M4S: The CTD — Safety and Safety Appendices
Target audience:
Pharmaceutical industry, regulatory affairs professionals
Document format:
Templates and tables for data presentation
Key topics:
Absorption, distribution, metabolism, excretion, plasma protein binding, study in pregnant or nursing animals
Year:
N/A
Region / City:
N/A
Subject:
Pharmaceutical Documentation, eCTD
Document Type:
Regulatory Guidance
Organization / Institution:
FDA
Author:
N/A
Target Audience:
Pharmaceutical Industry
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2023
Region / City:
South Africa
Topic:
eCTD validation for new registration of medicinal products
Document Type:
Template
Organization:
SAHPRA
Author:
Not specified
Target Audience:
Applicants submitting new registration applications for medicinal products in eCTD format
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified