№ files_lp_3_process_9_67202
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File size: 196 KB
A guideline document outlining the procedures for reporting serious adverse events (SAEs) to the DMID-CROMS Pharmacovigilance Group, including submission timelines and contact information.
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
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:
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:
2025
Note:
Region / City
Subject:
Wireless LAN, Privacy, SAE Credentials, Security
Document Type:
Technical Proposal
Organization / Institution:
IEEE
Author:
Dan Harkins (HPE), Michael Montemurro (Huawei), Jouni Malinen (Qualcomm Technologies, Inc.)
Target Audience:
Developers, Engineers, Researchers in Wireless LAN Security
Approval Date:
2025-07-29
Context:
This document outlines proposed changes to IEEE P802.11bi regarding the encryption of SAE password identifiers to enhance privacy and prevent eavesdropping during authentication exchanges between CPE Clients and CPE APs.
Note:
Year
Year:
2021
Note:
Region / City
Topic:
Wireless LAN Security
Document Type:
Standard
Organization / Institution:
IEEE
Author:
Po-Kai Huang, Ido Ouzieli, Ilan Peer, Johannes Berg
Target Audience:
Technical professionals and developers in wireless networking
Approval Date:
2021-06-29
SUBJECT:
Submittal of Substantiating Information to Support the [INSERT NAME OF PROGRAM] Milestone B Section 4252 Certifications and Determination
Year:
2017
Region / City:
United States
Note:
Subject
Major defense acquisition program, Milestone B approval
Document Type:
Memorandum
Organization:
Department of Defense
Author:
Not specified
Target Audience:
Defense acquisition professionals
Period of Action:
Not specified
Approval Date:
[INSERT DATE]
Date of Changes:
Not specified
Year:
2023
Date:
March 21, 2023
Location:
Galesburg, MI
Company:
TecNiq Inc.
Contact:
Don Kennedy, Marketing Specialist
Document Type:
Press Release
Product Name:
T67 6” Oval Light
Product Category:
LED Vehicle Lighting
Compliance Standards:
FMVSS 108; SAE J595; IP68
Warranty:
Lifetime Warranty
Mounting Type:
Grommet Mounted with AMP Connector
Lens Options:
Clear Lens
LED Configurations:
Amber Flasher with Diffused Reverse; Stop with Diffused Taillight; Stop/Tail/Turn with Diffused Reverse; Reverse with Additional Diffused Reverse
Intended Applications:
Dump Trucks; Refuse Trucks; Bucket Trucks; Trailers; Fleet Vehicles; Construction Equipment; Boats
Note:
Year
Year:
2020
Region / city:
Global
Topic:
Clinical research ethics, reporting of serious adverse events
Document type:
Standard Operating Procedure (SOP)
Organization:
ISU-IREB
Author:
ISU-IREB SOP Team
Target audience:
Researchers, ethics committees, clinical trial personnel
Period of validity:
Ongoing
Approval date:
2020
Date of amendments:
None
Description:
This document provides procedures for the reporting and evaluation of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in clinical research.
Year:
2015
Region / City:
Plymouth, Mich.
Topic:
Automotive, Fuel Efficiency, Engineering Competition
Document Type:
Press Release
Organization:
Freudenberg-NOK Sealing Technologies
Author:
Cheryl Eberwein, Leslie Dagg, Adriana Van Duyn
Target Audience:
Automotive industry professionals, engineering students, SAE competitors
Period of Action:
June 2015
Approval Date:
June 23, 2015
Modification Date:
N/A
Note:
Context
Year:
1990-1993
Region / City:
Chevy OBS trucks
Topic:
Automotive AC Installation
Document Type:
Technical Instructions
Organization / Institution:
Kwik Performance
Author:
Not specified
Target Audience:
Automotive mechanics and enthusiasts
Effective Period:
Not specified
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
Note:
Year
Brand:
Kwik Performance
Product:
AC Hose Kit
Vehicle Compatibility:
Chevy OBS trucks (1991–1993 and some 1990 models with SAE fittings)
Compressor Compatibility:
Sanden compressors (508, 709, SD7B10, 7176)
Vehicle System:
Automotive air conditioning (AC)
Document Type:
Installation instructions
Components Described:
#10 suction hose, #8 pressure hose, ½” hardline with 90-degree bend, safety switch fitting
Related Parts:
Sanden HD compressor, Sanden Mini compressor, 90-degree manifold (part number 342310), straight manifold kit (part number K10550)
Recommended Replacement Part:
Receiver/drier (accumulator)
Recommended Service Operation:
Orifice tube replacement in condenser lower tube
Technical Specifications:
Final torque 15–20 lb/ft for #8 pressure hose and 21–27 lb/ft for #10 suction hose
System Fluids Mentioned:
PAG oil
Reference Link:
https://www.kwikperf.com/collections/air-conditioning
Topic:
Automotive AC hose installation and compressor connection procedure
Year:
2023
Note:
Region / City
Topic:
Financial Information, Education
Document Type:
Instructional Guide
Organization / Institution:
Commission on Accreditation in Physical Therapy Education (CAPTE)
Target Audience:
Doctor of Physical Therapy Programs
Period of Validity:
2023-2024
Context:
Instructions for completing and posting the 2023 DPT Student Financial Fact Sheet as required by CAPTE for accredited Doctor of Physical Therapy programs.