№ files_lp_4_process_3_120119
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Clinical research procedural guidance outlining definitions, examples, reporting timelines, submission methods, and documentation requirements for protocol deviations in studies overseen by the Division of Microbiology and Infectious Diseases.
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
Price: 8 / 10 USD
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Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
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
Note:
Year
Subject:
Subcontractor Deviation Disposition Request Process
Document Type:
Instruction Manual
Organization / Institution:
Los Alamos National Laboratory (LANL)
Target Audience:
Subcontractors, Procurement, Engineering Teams
Note:
Date of event
Note:
Year
Year:
2023
Region / City:
N/A
Topic:
Request for deviation or waiver related to procurement processes
Document Type:
Form
Agency / Organization:
Sikorsky
Author:
N/A
Target Audience:
Contractors, procurement officers
Validity Period:
N/A
Approval Date:
N/A
Modification Date:
N/A
Form number:
KSU-IRB 022-E
Document type:
Log form
Topic:
Protocol deviations in human subjects research
Institution:
King Saud University
Oversight body:
Research Ethics Committee
Regulatory context:
Institutional Review Board compliance
Related roles:
Principal Investigator; Compliance Monitor; IRB
Included sections:
Protocol information; Deviation records; CAPA plan; Findings; Signatures
Applies to:
Research involving human participants
Source type:
Institutional research compliance record
Year:
2025
Region / city:
Dallas, TX
Topic:
Request for deviation or waiver in defense procurement
Document type:
Form
Organization / institution:
Lockheed Martin
Author:
Lockheed Martin
Target audience:
Government procurement officers, contractors, defense industry professionals
Effective period:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Note:
Year
Time Period Covered:
January 1 - June 30; July 1 - December 31
Document Type:
Excess Emission Report
Applicable Program:
Air Quality Permit Program
Submission Deadlines:
January 30, July 30, January 31
Deviation Reporting Method:
DRF-2 form for deviations not captured by CEMS
Year:
2023
Region / City:
Not specified
Subject:
Quality Control
Document Type:
Template
Organization / Institution:
University of Birmingham
Author:
Not specified
Target Audience:
Laboratories performing analyses in clinical trials
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2019
Region / City:
Colorado Springs, Colorado
Subject:
Engineering design deviation request
Document Type:
Form
Organization / Institution:
Planning and Community Development Department
Author:
Not specified
Target Audience:
Applicants and engineers submitting deviation requests
Period of Validity:
Indefinite
Approval Date:
6/26/2019
Date of Changes:
Not specified
Year:
2023
Region / City:
Nevada
Theme:
Air Pollution Control
Document Type:
Notification Form
Agency:
Nevada Division of Environmental Protection – Bureau of Air Pollution Control
Author:
Not specified
Target Audience:
Facilities under environmental regulation
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2020
Region / City:
USA
Topic:
Clinical Trials, Compliance, Noncompliance
Document Type:
Policy
Institution:
NIH, COMIRB
Author:
COMIRB
Target Audience:
Clinical researchers, IRB staff
Effective Date:
December 1, 2020
Revision Date:
August 18, 2016
Scope:
Clinical research trials, Compliance and Noncompliance Procedures
Year:
2021
Region / City:
Nevada
Topic:
Air Pollution Control
Document Type:
Notification Form
Organization:
Nevada Division of Environmental Protection – Bureau of Air Pollution Control
Author:
Not specified
Target Audience:
Companies subject to air pollution control regulations
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Method of measuring the maximum frequency deviation of FM broadcast emissions at monitoring stations
Year:
2019
Region / city:
Geneva
Topic:
Spectrum management, FM broadcasting
Document type:
ITU Recommendation
Author:
ITU
Target audience:
Radiocommunication professionals
Period of validity:
Ongoing
Approval date:
2019
Date of changes:
2019
Keywords:
FM broadcasting, frequency deviation, measurement, modulation power, monitoring
Related documents:
Recommendation ITU-R BS.412
Context:
A technical recommendation describing methods for measuring FM broadcast emissions, focusing on frequency deviation and modulation power at monitoring stations.