№ files_lp_3_process_9_33726
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Administrative form template outlining institutional requirements and procedures for documenting and reporting protocol deviations in human research studies under BU Medical Campus and BMC IRB oversight.
Organization:
BU Medical Campus and BMC IRB
Document Type:
Administrative Form Template
Subject:
Protocol Deviation Tracking and Reporting
Related Policy:
HRPP Policy 6.6.3.2
Applicable System:
REDCap
Oversight Authorities:
BU Medical Campus IRB; BMC IRB; External IRBs; Sponsors; Funders; Regulatory Agencies
Purpose:
Study-wide documentation of protocol deviations
Scope:
Overall study tracking, not event-specific source documentation
Reporting Requirement:
Submission required for deviations meeting reporting criteria regardless of IRB of record
Version Control:
Study-specific version date to replace CRRO template version date
Usage Period:
Duration of study data collection
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
Not specified
Topic:
Automation in conjunction with Fast Path Online Restructure/EP
Document Type:
Knowledge Article
Organization / Institution:
BMC
Author:
Not specified
Target Audience:
IT professionals working with IMS systems
Period of validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Context description
Note:
Year
Year:
2022
Region / City:
Boston, MA
Subject:
Health care facility expansion, hospital renovation, inpatient bed and operating room addition
Document Type:
Report
Organization / Institution:
BMC Health System, Inc.
Author:
BMC Health System, Inc.
Target Audience:
Public Health Council, Health professionals, Policy makers
Period of Action:
2022-2023
Approval Date:
December 14, 2022
Date of Changes:
Not specified
Year:
2020
Region / City:
United States, Marine Corps
Subject:
IT Asset Management, Cybersecurity
Document Type:
Performance Work Statement
Author:
Marine Corps Cyberspace Operations Group (MCCOG)
Target Audience:
Government contractors, IT professionals, system administrators
Period of Effect:
April 2020 onwards
Approval Date:
April 2020
Modification Date:
N/A
Classification:
Unclassified and Classified Environments
Contractor:
N/A
Security Requirements:
Compliance with DISA STIG standards
Technology:
BMC Discovery, BMC Remedy
Systems/Software:
UNIX, Windows, Database systems, Network devices, Cloud environments
Infrastructure Requirements:
CPU, RAM, Hard Disk, NIC, DHCP, Backup
Purpose:
To provide engineering, design, installation, and configuration of BMC Discovery software and its integration with BMC Remedy ITSM suite for asset management and discovery
Related Documents:
MARFORCYBERCOM GENADMIN 20-0008
Year:
2025
Organization:
BMC Health System, Inc.
Location:
Boston, MA, USA
Program:
ACO LEAP Certification
Issuing Authority:
Health Policy Commission (HPC)
Recipient:
Mr. Gregory Jones
Effective Period:
January 1, 2026 – December 31, 2027
Type of Document:
Certification Letter
Purpose:
Confirmation of meeting LEAP standards and recertification as ACO
Contact:
Courtney Anderson, Senior Manager, [email protected]
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.
Year:
Not specified
Region / city:
Not specified
Subject:
Actuarial practice, insurance liabilities
Document type:
Compliance questionnaire
Organization / institution:
Institute of Actuaries of India
Author:
Not specified
Target audience:
Appointed actuaries
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Confidentiality:
Yes