№ lp_1_2_33661
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The document provides guidance to inspectors regarding early initiation of safety systems and human intervention in nuclear facilities.
Year:
2024
Note:
Region / city
Topic:
Safety systems, Nuclear facilities
Document Type:
Technical Assessment Guide
Organization / Institution:
Office for Nuclear Regulation (ONR)
Author:
Human Factors Safety Inspector
Target Audience:
Inspectors, Nuclear facility staff
Issue:
7.2
Next Scheduled Review:
November 2029
Date of Publication:
November 2024
Document Reference:
NS-TAST-GD-010
Record Reference:
2021/57204
Revision Commentary:
Fit for purpose review. New template and check of validity of references.
Scope:
Guidance on safety systems in nuclear facilities, with an emphasis on human factors and operator actions within the 30-minute window.
Relationship to other legislation:
Includes reference to Licence Conditions (LCs) and relevant Safety Assessment Principles (SAPs).
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / city:
Bern, Switzerland
Theme:
Clinical Trials, Monitoring
Document Type:
Template
Organization / institution:
Swiss Clinical Trial Organisation (SCTO)
Author:
Monitoring Platform of the SCTO
Target audience:
Clinical trial monitors, study staff
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Theme:
Clinical Trial Management
Document Type:
Protocol
Target Audience:
Research Coordinators, Study Personnel
Year:
2015
Region / City:
Not specified
Subject:
Clinical Research Procedures
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
Clinical Research Center (CRC)
Author:
Not specified
Target Audience:
Site staff involved in clinical trials
Period of validity:
Not specified
Approval Date:
01/01/2015
Effective Date:
06/01/2016
Revision History:
Ongoing, with revision dates
Source Documents:
Clinical trial records, CRFs, IRB approvals, training certificates
Sponsor:
Not specified
Keywords:
Site Initiation Visit, SOP, clinical trial, CRC
Year:
2023
Region / City:
Canberra
Document Type:
Medical procedure
Organization:
Canberra Health Services
Author:
Not specified
Target Audience:
Medical professionals, including Neurologists, Geriatricians, Nurses, Pharmacists, and Students under supervision
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
[Date]
Region / city:
[Location]
Topic:
Project Management
Document Type:
Project Initiation Document
Organ / Institution:
[Institution Name]
Author:
[Author Name]
Target Audience:
Project Managers, Project Teams, Stakeholders
Effective Period:
[Start Date] - [End Date]
Approval Date:
[Date]
Amendment Date:
[Date]
Note:
Contextual Description
Year:
Not specified
Region / City:
Not specified
Subject:
Clinical trial preparation, study initiation, investigational product handling
Document Type:
Educational Material
Institution / Organization:
Not specified
Author:
Dr. Chen
Target Audience:
Clinical trial staff, researchers, regulatory bodies
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / city:
North East London
Topic:
Healthcare, Diabetes, Continuous Glucose Monitoring
Document Type:
Medical Guidance
Organization:
Barts Health NHS Trust, Homerton Healthcare NHS Foundation Trust, Barking, Havering and Redbridge University Hospitals NHS Trust
Author:
Specialist diabetes teams
Target Audience:
Healthcare professionals, primary care physicians
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
August 2023
Note:
Context description
Year:
2017
Region / City:
Kent State University
Subject:
Clinical Research
Document Type:
Standard Operating Procedure (SOP)
Institution:
Kent State University
Author:
Not specified
Target Audience:
Clinical research staff, Principal Investigators, Study Coordinators
Period of Validity:
Ongoing
Approval Date:
01/29/2017
Revision Date:
Not specified
Note:
Year
Note:
Year
Topic:
Initiation Ritual
Document Type:
Ritual Preparation Guide
Target Audience:
Associate Chapters & Chapters
Year:
2020
Note:
Region / City
Theme:
Payments Initiation, ISO 20022
Document Type:
Message Definition Report
Author:
SWIFT, IFX, OAGi, TWIST
Target Audience:
Payments Standards Evaluation Group (SEG)
Period of Validity:
2020-2021
Document Scope:
Covers customer-to-bank payment initiation messages
Message Definitions:
pain.001, pain.007, pain.002, pain.008
Business Process:
Customer-to-bank payments and collections
Business Role:
Financial institutions, debtors, creditors
Document Objective:
Provide message definitions for payments initiation
Description:
This document outlines the context and objectives of a set of messages developed for payments initiation in the ISO 20022 standard, including message flows and business scenarios.
Year:
2026
Region / City:
Global
Theme:
Project Management
Document Type:
Project Plan
Organization / Institution:
Various
Author:
Various
Target Audience:
Project Managers, Stakeholders
Effective Period:
Ongoing
Approval Date:
[TBD]
Date of Changes:
[TBD]
Organization:
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
Document type:
Guidance document
Subject:
Delegation of Tasks Logs (DTLs) and Registration and Credential Repository (RCR) procedures
Applicable to:
ULACNet clinical research studies
Regulatory framework:
Good Clinical Practice (GCP), Food and Drug Administration (FDA), National Cancer Institute (NCI) requirements
Related entities:
Lead Academic Organizations (LAOs); DCP Regulatory Contractor
Scope:
Accruing clinical research sites participating in ULACNet protocols
Referenced standards:
ICH GCP E6 R2; FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
Purpose:
Requirements and procedures for initiation, completion, submission, review, and maintenance of DTLs and RCR registrations
Audience:
Site principal investigators, investigators, sub-investigators, and clinical research personnel involved in ULACNet studies
Year:
2010
Region / City:
St. Matthew Parish, Charlotte, NC, USA
Subject:
Catholic Faith Formation
Document Type:
Handbook
Organization / Institution:
St. Matthew RCIA Team
Author:
RCIA Team and Pastoral Staff
Target Audience:
Prospective Catechumens and Candidates
Application Period:
2010–2011
Interviews Deadline:
January 2011
Retreats:
Winter one-day retreat, Spring three-day retreat
Sacraments Covered:
Baptism, Confirmation, Eucharist
Contact Information:
RCIA Coordinator: Tom Lindemuth, Email: [email protected]
, Phone:
(704) 840-4088; Sponsor Coordinator: Jane Brock, Email: [email protected]
Note:
, Phone
(704) 936-7400
Year:
2026
Region / City:
United Kingdom
Theme:
Pharmaceutical Treatment
Document Type:
Prescribing Information
Organization:
NHS
Author:
Dr. Joanne Ritchie
Target Audience:
Healthcare professionals, specifically specialists and GPs
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Contraindications:
Venous thromboembolic disorder, arterial thromboembolic disease, known thrombophilic disorders, known osteoporosis, headaches with focal neurological symptoms, pregnancy, breastfeeding
Monitoring:
DEXA scan recommended after 1 year of treatment
Special Warnings/Precautions:
Use of non-hormonal contraception for at least 1 month after initiation
Adverse Effects:
Hot flushes, headache
Primary Care responsibilities for continuation:
Prescribe as recommended, seek advice from the specialist if needed
Specialist Service responsibilities for initiation:
Discuss benefits and side effects with the patient, initiate treatment and monitor
Criteria for Discontinuation:
Menopause, increase in migraine frequency, ATE/VTE events, acute liver deterioration
Date of Initiation:
Not specified
Communication:
Contact details for the specialist and hospital pharmacy provided
Year:
2023
Region / City:
United Kingdom
Topic:
Nuclear Safeguards
Document Type:
Technical Inspection Guide
Organization / Institution:
Office for Nuclear Regulation (ONR)
Author:
Safeguards Inspector
Target Audience:
Inspectors, Operators
Period of Validity:
Until June 2026
Approval Date:
January 2023
Review Date:
June 2026
Date of Updates:
January 2023, June 2026
Document Reference:
SG-INSP-GD-001
Record Reference No.:
ONRHH-822789359-20562
Year:
2024
Region / city:
Great Britain
Theme:
Nuclear Power, Safety and Security, Regulatory Process
Document Type:
Guideline
Organization:
Office for Nuclear Regulation (ONR)
Author:
M Connolly, T Parkes
Target Audience:
Requesting Parties (RP) including vendors and partner organizations
Period of Effect:
2007–2027
Approval Date:
August 2024
Next Major Review Date:
August 2027
Document Reference:
ONR-GDA-GD-006
Record Reference:
2024/34844
Revision Commentary:
Formatting updates and content review
Contextual Description:
A guideline document detailing the Generic Design Assessment (GDA) process for safety and security assessments of new Nuclear Power Plants (NPP) by the Office for Nuclear Regulation (ONR).
Year:
2025
Region / city:
Devonshire Dock Complex
Subject:
Nuclear Safety Inspection
Document Type:
Regulatory Report
Organization:
Office for Nuclear Regulation (ONR)
Author:
Nominated Site Inspector
Target Audience:
Public, Local Liaison Committee Members
Period of Effect:
January 1, 2025 – June 30, 2025
Approval Date:
August 2025
Date of Changes:
May 2025
Contextual Description:
Regulatory report on nuclear site inspections conducted at BAE Systems Marine Limited, detailing both routine and non-routine activities, including fire safety and incident investigations.
Year:
2025
Region / City:
Not specified
Topic:
Nuclear Safety, Property Transactions
Document Type:
Technical Inspection Guide
Organization / Institution:
Office for Nuclear Regulation (ONR)
Author:
Nuclear Safety Inspector
Target Audience:
Inspectors, Nuclear Facility Licensees
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / city:
Dungeness
Topic:
Nuclear site inspections
Document type:
Site report
Organization / institution:
Office for Nuclear Regulation (ONR)
Author:
Nominated Site Inspector Dungeness B
Target audience:
Stakeholders, public
Period of validity:
1 April – 30 June 2025
Approval date:
August 2025
Date of changes:
None