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This document provides a comprehensive quality manual template for biobanks to establish, manage, and improve their quality management systems, addressing processes, procedures, and responsibilities across biobank operations.
Year:
2023
Region / city:
Switzerland
Subject:
Quality management, biobank operations, ISO 20387
Document Type:
Manual
Organization / institution:
Biobank
Author:
Biobank team
Target audience:
Biobank personnel, auditors, customers, external collaborators
Validity Period:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
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Data Sharing Agreement between the University of Oxford and Data User for the China Kadoorie Biobank
Year:
2026
Region / City:
Oxford, United Kingdom; Beijing, China
Subject:
Data Sharing, Research Collaboration
Document Type:
Agreement / Contract
Organization:
The Chancellor, Masters and Scholars of the University of Oxford; Peking University
Parties Involved:
Oxford University, Data User
Effective Date:
[as specified in document]
Term:
[from Effective Date to conclusion of Approved Research or specified end date]
Scope:
Access and use of China Kadoorie Biobank data for approved research
Intellectual Property:
Arising Intellectual Property owned by Data User; licence granted to Oxford for teaching and research
Publication Conditions:
Submission of results to Oxford prior to public release
Data Protection:
Compliance required with Schedule 4
Year:
2026
Region / city:
UK
Topic:
Genetics, Mental Health
Document Type:
Research Study
Organization / Institution:
King’s College London, Université Laval
Author:
Genevieve Morneau-Vaillancourt, Jonathan R. I. Coleman, Kirstin L. Purves, Rosa Cheesman, Christopher Rayner, Gerome Breen, Thalia C. Eley
Target Audience:
Researchers, Academics, Healthcare Professionals
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2020
Region / City:
N/A
Theme:
Biobank Protocol, Research Standards
Document Type:
Template
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Researchers, Biobankers
Validity Period:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2018
Region / city:
Belgium
Subject:
Biobank submission to ethics committee
Document type:
Declaration form
Institution:
Ethics committee
Author:
Biobank manager
Target audience:
Biobank managers, ethics committees, research institutions
Date of approval:
Not specified
Date of amendments:
Not specified
Year:
2021
Region / City:
Australia
Subject:
Biobank protocol for research projects
Document type:
Protocol template
Organization:
Various research institutions
Author:
Not specified
Target audience:
Researchers and investigators
Period of validity:
Ongoing
Approval date:
Not specified
Date of changes:
October 2021
Authors:
Jasmine Gratton; Steve E Humphries; Marta Futema
Institutions:
Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London, United Kingdom; Cardiology Research Centre, Molecular and Clinical Sciences Research Institute, St George’s University of London, London, United Kingdom
Country:
United Kingdom
Data source:
UK Biobank
Study design:
Population-based cohort study
Subject:
Prevalence of FH-causing genetic variants and association with LDL-C levels across ancestry groups
Population:
European, South Asian, and African ancestry participants
Sample size:
140,439 European; 4,067 South Asian; 3,906 African participants with lipid and whole exome sequencing data
Genes analysed:
LDLR; APOB; PCSK9
Methods:
Principal component analysis; whole exome sequencing; variant classification using ACMG guidelines
Outcome measures:
Prevalence of pathogenic and likely pathogenic FH variants; LDL-C concentration adjusted for statin use; prevalence and incidence of coronary heart disease
Period of data collection:
2006–2010
Ethical approval:
Conducted under approved UK Biobank application 40721
Type of document:
Scientific research article
Year:
2023
Region / Country:
United Kingdom
Topic:
Air pollution epidemiology
Document type:
Supplementary material / Research dataset description
Institution:
UK Biobank
Data sources:
UKB database, spatio-temporal PM2.5 exposure model
Variables:
Demographics, lifestyle factors, environmental exposures, health outcomes
Methodology:
Cox proportional hazards models with various adjustment strategies
Target population:
UK Biobank participants
Data collection period:
Baseline recruitment and follow-up until 2017
Publication date:
2023
Endnote citation:
Provided in main manuscript reference list
Year:
2023
Region / City:
NSW, Australia
Topic:
Biobank, Inventory Verification, SOP
Document Type:
Standard Operating Procedure
Organization:
NSW Biobank
Author:
NSW Biobank Staff
Target Audience:
Biobank Personnel, Laboratory Technicians, Biobank Managers
Effective Period:
Ongoing
Approval Date:
2023
Modification Date:
Not specified
Note:
Related Documents
NSW/CTRNet Required Operational Practice 6:
Quality Management Systems and Process Improvement
NSW/CTRNet Required Operational Practice 10:
Biospecimen Storage and Retrieval
NSWHSB SOP 4.7:
Biobank Biospecimen Retrieval
NSWHSB SOP 6.2:
Biobank Data Retrieval and Transmission
Materials:
Inventory Management System (Database), Safety Equipment, Ice, Dry Ice, Liquid Nitrogen
Safety:
Follows Institutional Biosafety Guidelines
Type of document:
Supplementary research materials
Research topic:
Cardiovascular health and carotid artery stenosis prevention
Study population:
UK Biobank participants
Sample size:
270,695 participants
Country:
United Kingdom
Dataset:
UK Biobank
Variables examined:
Life’s Essential 8 score, family cardiovascular risk, carotid artery stenosis incidence
Health factors analyzed:
diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, blood pressure
Covariates:
age, sex, ethnicity, Townsend deprivation index, alcohol drinking status, education level, income level, employment status, medication use, sedentary time
Disease classification system:
ICD-9 and ICD-10 codes
Statistical methods:
hazard ratios, logistic regression analysis, population attributable risk estimation, sensitivity analysis
Content elements:
disease definitions, covariate definitions, missing data proportions, LE8 component scoring system, stratified analyses, sensitivity analyses, participant selection diagram, score distributions, risk category frequencies, cumulative incidence figures
Document number:
2.02.006
Version:
1.0
Category:
Governance
Sub-category:
Regulatory Affairs
Authored by:
Swiss Biobanking Platform
Effective date:
Not specified
Biobank:
NameProject
Research ID code:
Code
Project Leader/Sponsor or BB Manager/Director:
Name
Key-keeper:
Name & contact
Participant information:
CODE, Last Name, First Name, Date of Birth, Sex
Confidentiality status:
Confidential
Revision history:
Document number 2.02.005, Author SBP, Initial release
Year:
Not specified
Region / City:
UK
Topic:
Diabetes, Glycated Hemoglobin, Cancer Risk
Document Type:
Research Supplementary Table
Institution:
UK Biobank
Author:
Not specified
Target Audience:
Researchers, Healthcare Professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2018
Region:
United Kingdom
Document Type:
Application Form
Organization:
UKCRC Tissue Directory Coordinating Centre (TDCC)
Intended Audience:
Human tissue resource managers and researchers
Submission Requirements:
Maximum of two research case studies
Assessment Criteria:
Impact of research, role of resource, added value, fit-for-purpose, engagement activities
Contact Information:
Main contact details provided in form
Research Type:
Human tissue resource utilization
Format:
Electronic A0 conference poster for case studies
Year:
2024
Region / City:
South Carolina
Topic:
Request for Proposal / Government Procurement
Document Type:
Solicitation
Organ / Institution:
South Carolina Department of Mental Health, South Carolina Department of Veterans’ Affairs
Author:
State Fiscal Accountability Authority
Target Audience:
Potential Offerors (Bidders)
Period of Action:
3/1/2025 – 2/28/2030
Approval Date:
12/6/2024
Amendment Date:
N/A
Year:
2025
Region / city:
Tasmania
Subject:
Caretaker conventions and government operations
Document type:
Guidelines
Institution:
Department of Premier and Cabinet
Author:
Department of Premier and Cabinet
Target audience:
Tasmanian Government Ministers, Ministerial staff, employees and officers of Tasmanian State Service agencies, Government Business Enterprises, State-owned Companies
Period of validity:
During the caretaker period of the Tasmanian State Election 2025
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2023
Region / City:
Foothills
Topic:
HOA Dues, Operating Costs, Board Decisions
Document Type:
Notice
Organization / Institution:
Foothills HOA Board
Author:
Foothills HOA Board
Target Audience:
Homeowners
Effective Period:
From March 2023 onwards
Approval Date:
March 30, 2023
Amendment Date:
None
Year:
Not specified
Region / City:
Not specified
Subject:
Heat treatment, welding, bending, forming
Document Type:
Technical standard
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Professionals in welding, bending, and forming
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2010
Region / City:
Europe
Theme:
Grid Computing, Infrastructure, e-Science
Document Type:
Policy
Organization / Institution:
EGI-InSPIRE
Author:
David Kelsey
Target Audience:
Researchers, Site Administrators, Grid Operators
Approval Date:
13/07/2010
Approval Body:
EGI-InSPIRE
Modification Date:
N/A
Date of Document:
13/07/2010
Version:
1.0
Policy Group:
Security Policy Group
Contact Person:
David Kelsey, STFC, UK
Note:
Year
Institution:
Fire College
Course Number:
BFST1302
Course Title:
Fire Apparatus Operations
Document Type:
Worksheet
Purpose:
Course-to-Course Equivalency Request
Target Audience:
Applicants seeking course equivalency
Requirements:
Completed syllabus, transcript, and detailed JPR satisfaction documentation
Contact:
[email protected]
Document type:
Task book
Subject:
Trench rescue operations
Standard reference:
NFPA 1670
Intended use:
Skills evaluation and certification documentation
Issuing context:
Fire and rescue training programs
Responsible authority:
Fire Chief or Agency Head
Candidate role:
Trench Rescue Operations candidate
Evaluator role:
Supervisor or designated evaluator
Verification method:
Signatures and student identification numbers
Scope of skills:
Trench and excavation emergency operations
Format:
Form with evaluative checklist