№ files_lp_3_process_7_049806
File format: docx
Character count: 1709
File size: 72 KB
Regulatory procedural guideline outlining criteria, responsibilities, timelines, and review processes for registration and maintenance of DMID-supported clinical study records in the ClinicalTrials.gov registry under FDAAA and NIH policy requirements.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
United States
Topic:
Clinical Trials, Research, Medical Studies
Document Type:
Glossary
Organization / Institution:
National Institutes of Health (NIH)
Author:
National Library of Medicine (NLM)
Target Audience:
Clinical researchers, healthcare professionals, medical librarians
Period of validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
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
Year:
Not specified
Region / City:
Virginia
Theme:
Education, Special Education, Assessment Criteria
Document Type:
Program Participation Criteria
Organization / Institution:
Virginia Department of Education
Author:
Not specified
Target Audience:
IEP Teams, Educators, Parents
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Theme:
Rental Screening
Document Type:
Policy
Organization / Institution:
SG Property Management
Target Audience:
Applicants
Year:
Not specified
Region / City:
Not specified
Subject:
Youth Employment, Eligibility Criteria, Documentation
Document Type:
Guidelines
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Youth (14-24 years old)
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
College of Criminal Justice Outstanding Dissertation Award Nomination Process and Selection Criteria
Year:
2022
Region / City:
Sam Houston State University
Topic:
Dissertation Award
Document Type:
Nomination and Selection Criteria
Institution:
College of Criminal Justice
Author:
Not specified
Target Audience:
Faculty members, doctoral students
Effective Period:
Ongoing (annual)
Approval Date:
09/27/2022
Modification Date:
Not specified
Year:
2026
Region / City:
United States
Topic:
IRB Approval Criteria
Document Type:
Worksheet
Organization / Institution:
University of Washington
Author:
Not specified
Target Audience:
IRB Chair, IRB members, designated reviewers, and HSD staff
Period of Validity:
Ongoing
Approval Date:
01.29.2026
Date of Changes:
01.29.2026
Year:
N/A
Region / City:
N/A
Subject:
Therapeutic Hypothermia, Neonatal Care
Document Type:
Clinical Guideline
Organization:
N/A
Author:
N/A
Target Audience:
Healthcare Providers
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2026
Region / City:
Missouri
Topic:
Hereditary Angioedema Treatment
Document Type:
Proposal
Institution:
MO HealthNet
Author:
MO HealthNet and Conduent
Target Audience:
Health professionals and stakeholders in the MO HealthNet program
Effective Period:
Starting from May 9, 2019
Approval Date:
January 20, 2026
Modification Date:
Not specified
Document Status:
Revision of Existing Criteria
Context:
A proposal outlining the preferred drug list and approval criteria for hereditary angioedema treatment agents within the MO HealthNet program.
Year:
2023
Region / City:
Germiston
Subject:
Procurement, Tender Process
Document Type:
Formal Written Price Quotation
Organization:
Department of Finance
Author:
Ms Bekane Molekwa, Acting Senior Manager Procurement Office
Target Audience:
Bidders, Service Providers, Municipal Contractors
Validity Period:
Until 30 June 2026 or until a tender is in place
Approval Date:
1 March 2024
Date of Amendments:
14 December 2023
Procurement Value:
Up to R750,000.00
Specific Requirements:
50% Disability, Preferential Procurement
Description:
Official document outlining the formal procurement process and requirements for appointing a service provider to supply, deliver, and off-load order forms for the Department of Finance, Ekurhuleni municipality.
Year:
2018
Region / City:
Minnesota
Theme:
Supportive Housing, Homelessness Assistance
Document Type:
Policy Change Notice
Organization:
Minnesota Housing
Author:
Minnesota Housing
Target Audience:
Housing providers, Coordinated Entry system managers
Effective Date:
January 1, 2019
Change Date:
2018
Period of Application:
2018-2019
Year:
2024-2025
Region / City:
Solihull
Theme:
Special Educational Needs and Disabilities (SEND) Funding
Document Type:
Policy/Guideline
Institution:
Solihull Local Authority
Author:
Solihull Local Authority
Target Audience:
Early years settings, education providers, local authorities
Period of Validity:
2024-2025
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / city:
Not specified
Topic:
Weight management, eligibility criteria
Document type:
Referral form
Organization / institution:
NHS
Author:
Not specified
Target audience:
Healthcare professionals (GPs, clinicians)
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Germiston
Theme:
Procurement / Public Sector
Document Type:
Formal Written Price Quotation
Author:
Department of Finance
Target Audience:
Bidders and Suppliers
Period of Validity:
Until 30 June 2026 or until a tender is in place, whichever comes first
Approval Date:
1 March 2024
Date of Changes:
14 December 2023