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Quality Management Manual
Version:
…1……………………………………………………..
Date Created:
…30.07.2013……………………………………………………..
……………………………………………………………..
Date of last review:
Date of next review: …30.07.2014……………………………………………………..
Name of Author:
Stephen McQuaid
Signature of Author:
Authorised by:
Jacqueline James
Signature:
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Contents
Abbreviations ........................................................................................................... 4
Introduction .............................................................................................................. 5
Section 1: Organisation and Quality Management System .................................. 6
Organisation and management .............................................................................. 6
NIB Operational Committee .................................................................................... 6
The NIB Steering Committee .................................................................................. 6
Ethics, Governance and HTA Advisory Group ........................................................ 7
Information Technology and Data Management Committee ................................... 8
Biosampling and Quality Assurance Committee (BQAC) ....................................... 8
Quality Policy .......................................................................................................... 9
Quality Management System .................................................................................. 9
Quality Objectives and Plans .................................................................................. 9
Quality Manager ..................................................................................................... 9
Quality Manual ........................................................................................................ 9
Document and version control ................................................................................ 9
Section 2: Governance .......................................................................................... 10
Ethical Approval .................................................................................................... 10
HTA permission .................................................................................................... 10
Sponsorship arrangements ................................................................................... 10
Research Governance arrangements ................................................................... 10
Access Policy ....................................................................................................... 11
Material Transfer Agreement ................................................................................ 11
Section 3: Personnel .............................................................................................. 11
Professional Direction ........................................................................................... 11
Staffing ................................................................................................................. 11
Training, competence and staff development ....................................................... 12
Job descriptions and contracts ............................................................................. 12
Staff meetings ....................................................................................................... 12
Staff training and education .................................................................................. 12
Section 4: Communications .................................................................................. 13
Internal communication......................................................................................... 13
External communication ....................................................................................... 13
Communication with patients and donors ............................................................. 13
Clinically relevant findings .................................................................................... 13
Communication with researchers.......................................................................... 13
Stakeholder feedback ........................................................................................... 14
Section 5: Premises and Environment ................................................................. 14
Premises and environment ................................................................................... 14
Facilities for staff ................................................................................................... 14
Facilities for patients ............................................................................................. 14
Facilities for storage.............................................................................................. 14
Health and safety .................................................................................................. 15
Risk Assessments ................................................................................................ 15
Equipment ........................................................................................................... 15
Section 6: Evaluation and quality assurance ...................................................... 15
Evaluation ............................................................................................................. 15
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Complaints ............................................................................................................ 15
Anomalies and non-conformities .......................................................................... 15
Section 7: Resources ............................................................................................. 16
Procurement ......................................................................................................... 16
Subcontracting ...................................................................................................... 17
Section 8: Handling of Samples ............................................................................ 17
Consent ................................................................................................................ 17
Traceability ........................................................................................................... 17
Samples ................................................................................................................ 17
Sample collection.................................................................................................. 17
Transport of samples ............................................................................................ 17
Selection and release of samples to researchers ................................................. 18
Quality control of samples .................................................................................... 18
Proficiency testing................................................................................................. 18
Disposal of samples.............................................................................................. 18
Section 9: Handling Data ....................................................................................... 18
Data ...................................................................................................................... 18
Data protection ..................................................................................................... 18
Data Security ........................................................................................................ 18
Data quality ........................................................................................................... 19
Return of research data ........................................................................................ 19
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Abbreviations
BHSCT
Belfast Health and Social Care Trust
BQAC
Biosampling & Quality Assurance Committee
CCRCB
Centre for Cancer Research and Cell Biology
COSHH
Control of Substances Hazardous to Health
CPA
Clinical Pathology Accreditation
CR-UK
Cancer Research UK
DHSSPS
Department of Health, Social Services and Patient Safety
DNA
Deoxyribonucleic acid
HSC R & D
Health and Social Care Research and Development
HTA
Human Tissue Authority
MTA
Material Transfer Agreement
NHS
National Health Service
NIB
Northern Ireland Biobank
NICR
Northern Ireland Cancer Registry
NICTC
Northern Ireland Cancer Trials Centre
NI- MPL
Northern Ireland Molecular Pathology Laboratory
NICRCF
Northern Ireland Cancer Research Consumer Forum
QMS
Quality Management System
QUB
Queen’s University Belfast
RNA
Ribonucleic acid
SOP
Standard Operating Procedure
TMA
Tissue Microarray
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Introduction
This quality manual outlines the practices and procedures which govern the
collection, processing, storage and distribution of human tissue and associated
biosamples within the Northern Ireland Biobank (NIB). It exists as part of the Quality
Management System (QMS) of the NIB.
Objectives of the quality manual:
-
To meet the requirements of the Human Tissue Act (2004) and the Human
Tissue Authority (HTA) Codes of Practice
To comply with local regulatory requirements
To provide information for NIB staff, NIB users and Accreditation bodies
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Section 1: Organisation and Quality Management System
Organisation and management
NIB Operational Committee
NIB Operational Team meet approximately every two months as the NIB Operational
Committee. These meetings are chaired either by the NIB Scientific Director or
Deputy Scientific Director. The meetings provide a forum for staff to feedback
experiences and to guide best practices and future developments.
The NIB Steering Committee
The NIB steering committee is currently chaired by the Belfast Health Social Care
Trust (BHSCT) Director of Research and Development and meets at least twice a
year to oversee the good practices of the NIB on an ongoing basis. The terms of
reference of this committee are as follows:6
-
-
To ensure, as much as possible, that the NIB develops in line with the
recommendations set out in the NI Biobanking Advisory Group Report.
To assess if sponsorship, governance and legal requirements are in place that
satisfy local and national requirements.
To agree and support the operational procedures put in place for the
biosample and data collections.
To assess and monitor the development of the NIB Information Technology
infrastructure, to ensure it is fit for purpose and can interface appropriately with
relevant parts of the Health and Social Care/Department of Health and Social
Services and Public Safety (DHSSPS), Northern Ireland Cancer Registry
(NICR) and other databases as appropriate and to ensure compatibility with
national and international activities for sample and data collection.
To agree and monitor the conditions under which researchers are given
access to the biological samples and data in the biobank.
To monitor the use of allocated funds for the NIB.
To assess the impact of the biobank on BHSCT and Queens University Belfast
(QUB) in relation to costs.
To evaluate promotional activities of the NIB and agree an effective
communication plan.
To consider and agree future developmental phases of the NIB, including
feasibility for a regional collection of samples and related data.
Membership of the NIB Steering Committee is usually for three years, renewable for
a further two. As the NIB becomes more established, it is hoped to extend the
membership to include service users, lay persons and representatives of patients
and survivorship. Currently it comprises:-
Director of Research & Development, Belfast Health & Social Care Trust
(Chair)
Scientific Director of Northern Ireland Biobank
Deputy Director, HSC Research and Development Division, Public Health
Agency
Director of the Northern Ireland Cancer Trials Centre (NICTC), BHSCT
Director, Northern Ireland Cancer Registry
Director, Centre for Cancer Research & Cell Biology (CCRCB), Queens
University Belfast
Professor of Molecular Pathology, Centre for Cancer Research & Cell Biology,
QUB
Clinical Lead for Tissue Pathology, Belfast Health & Social Care Trust
Senior academic representation from the QUB Centre for Public Health and
the Centre for Infection & Immunity
Senior academic representation from the Biomedical Sciences Research
Institute of the University of Ulster.
Ethics, Governance and HTA Advisory Group
These advisors assist and advise the Scientific Director on matters relating to
research governance, ethics and HTA compliance. Membership of the group
includes the Scientific Director and is approved by the NIB Steering Committee. The
group meets as required at the request of the NIB Scientific Director.
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Information Technology and Data Management Committee
This committee oversees the development of the information management system
designed to track the collection, storage and distribution of anonymised tissue
samples. This Committee is chaired by the CCRCB Professor of Bioimaging and
Bioinformatics and includes representation from PathXL, the IT company awarded
the tender to develop the NIB IMS.
IT and Data Management Committee Membership:
-
NIB Lead for IT and Data Management
NIB Scientific Director
NIB Deputy Scientific Director
NIB Administrator
NIB Clinical Research Nurses
NIB Digital Pathology Technician
PathXL Project Manager
PathXL Senior Software Developer
Biosampling and Quality Assurance Committee (BQAC)
This committee meets approximately every two months and deals with the practical
aspects of sampling and all quality assurance issues associated with samples in the
tumour collection. It is chaired by the NIB Deputy Director. NIB is closely integrated
with BHSCT Tissue Pathology at the Royal Victoria and the Belfast City Hospital.
This committee is critical for the success of biobanking and key NHS personnel
responsible for HTA documentation and standard operating procedures relating to
CPA accreditation of the NHS laboratories are involved.
Six consultant
histopathologists are supported through the Belfast CR-UK Centre and facilitate the
biobanking workflow within Tissue Pathology and NI-MPL. The BQAC oversees the
production of Standard Operating Procedures (SOPs) for all activities relating to NIB.
BQAC Committee membership:
-
NI Deputy Scientific Director and Quality Manager (chair)
Senior Biomedical Scientists BHSCT Tissue Pathology
Representation from BHSCT Consultant ‘CR-UK funded’ pathologists
NIB Biomedical Scientists
NI-Molecular Pathology Laboratory Biomedical Scientists
BHSCT Tissue Pathology Archivist
Quality Lead for BHSCT Tissue Pathology
NIB Clinical Research Nurse
NIB Digital Pathology Technician
NIB Administrator
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Quality Policy
NIB is committed to the creation of a resource to facilitate high calibre translational
research through the organised collection of biological samples linked with welldefined clinical and pathological data. The NIB will:





Operate a quality management system to achieve continual quality
improvement
Continually review and improve the NIB quality management system
Ensure that the needs and requirements of users are met
Ensure all NIB personnel are familiar with the contents of the quality manual,
procedures relevant to their work and this quality policy
Comply with all relevant regulatory, health and safety and environmental
legislation
Comply with the standards required by relevant accreditation bodies
This quality policy will be periodically reviewed to ensure its continuing suitability
Quality Management System
The components of the NIB QMS are described throughout this manual. NIB
Standard Operating Procedures which support the QMS Quality Objectives and
Plans are located on the NIB website at www.nibiobank.org other support documents
can be found on the QUB NI-MPL shared drive.
The NIB quality objectives and plans for forthcoming year are discussed and planned
at the NIB Steering Committee. Staff receive feedback via the Operational Team
Meetings.
Quality Manager
There is a designated Quality Lead (Chair of BQAC) for the NIB who is responsible
for implementing and maintaining the NIB quality management system.
Quality Manual
The quality manual is maintained by the NIB Administrator. It is reviewed and
updated yearly or as required by operational changes and changes are
communicated to relevant personnel by the NIB Administrator.
Document and version control
All documents relevant to the QMS of the NIB are reviewed and updated regularly or
as required. See SOP Admin 03 (Creation, Amendment, Retention and Destruction
of NIB Documentation).
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Section 2: Governance
The NIB is governed by the principles of transparency and accountability; it functions
within a strict regulatory framework and is compliant with the research governance
requirements of the two main stakeholders, namely Queen’s University Belfast and
Belfast Health and Social Care Trust.
Ethical Approval
NIB has generic ethics approval which was awarded by a recognized research
committee from the Office for Research Ethics Committees in Northern Ireland
(reference 11/NI/0013). The approval covers the prospective collection, storage and
distribution of a targeted collection of malignant tissues and related biosamples for
cancer focused research. The NIB also has approval in place to collect samples of
tissues and blood from individuals with premalignant or potentially malignant
conditions. Furthermore NIB has OREC (NI) approval to access and distribute for
research anonymised samples from the BHSCT laboratory archives. This includes
samples from the archives of tissue pathology, cytopathology, haematology and
molecular diagnostics. All amendments to the original application must be OREC NI
approved.
HTA Licencing Arrangements
The NIB is integrated within the NI-MPL, based in the QUB Centre for Cancer
Research and Cell Biology as a facility to store human samples for future research
under the QUB HTA Research licence (HTA licensing number 12044). The HTA is
aware that NIB samples stored in CCRCB are under the responsibility of the QUB
HTA Research licence DI.
The existing BHSCT Pathology HTA licence
arrangements ensures all HTA regulations are followed by NHS pathology for the
storage of tissue for as yet undefined research. The BHSCT pathology HTA licence
(HTA licensing number 12278) also facilitates the temporary storage of NIB
prospectively-collected frozen samples on the RVH site prior to batch transfers to the
long-term storage facility in CCRCB.
Sponsorship arrangements
Queen’s University Belfast and The Belfast Health and Social Care Trust are joint
sponsors of the Northern Ireland Biobank. In line with the requirements of both
institutions the NIB staff are trained in the principles of Good Clinical Practice and
have completed appropriate training on the Human Tissue Act 2004.
Research Governance arrangements
The NIB has worked with the Research Office of BHSCT and the Research
Governance Office of QUB to ensure a robust infrastructure is in place which
operates with a clear understanding of responsibility. The NIB works closely with the
Research Office of BHSCT and the Research Governance Office of QUB to ensure
there is appropriate tracking of all required documents for each application. Audits of
the application work flow are carried out by senior NIB personnel. Decisions
regarding access to the samples in the NIB are impartial and members of the
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scientific review team will be asked to agree to the principles of non-disclosure.
Independent-peer review is carried out by NIB for the majority of applications prior to
the release of samples. In some instances, the Scientific Director may make a
decision to release samples on the basis of proven, relevant peer-reviewed grant
income, for example for research council funded projects.
Access Policy
The NIB has an access policy which adheres to the over-arching access policies of
the Confederation of Cancer Biobanks.
Material Transfer Agreement
An overarching Material Transfer Agreement (MTA) between the provider
organisation (BHSCT) and the recipient organisation (QUB) is in place which
encompasses all movements of materials from BHSCT to the NIB. Release of
tissues to researchers for a funded, scientifically approved project is subject to a
QUB-Recipient MTA for use of the samples and this incorporates the terms from the
BHSCT-QUB MTA. The MTA forms part of the “application request for use of the
samples”. The Chief Investigator and the University’s Designated Individual (DI) are
required to sign the MTA once the application to request the use of the samples has
been approved and before any samples are released.
Section 3: Personnel
Professional Direction
The Scientific Director professionally leads the NIB.
Staffing
The NIB Director, Deputy Director and Administrator regularly reviews the workload
and staffing of the NIB to ensure the service is delivered by appropriately trained and
qualified staff:
NIB staff include:
-
Scientific Director
Deputy Director & Quality Lead
Administrator
IT and Data Management Lead
Clinical Research Nurses
Biomedical Scientists
Medical Laboratory Assistants
Digital Pathology Technician
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Training, competence and staff development
It is recognized that records of professional qualifications and/or training will be
maintained by the employing organization. The NIB maintains a central record of
biobank-specific training procedures which are documented and reviewed regularly.
This includes:
-
Induction for new NIB staff members
Training staff in skills specific to their job according to NIB SOPs
NIB competency framework document which is signed off by appropriately
trained NIB/NI-MPL personnel
A documented and reviewed approach to staff appraisal with annual review of
training needs and personal development plan.
Professional behaviour
NIB staff who have access to donor identities and/or donor identifiable data are
bound by the confidentiality policy of BHSCT.
Non NHS contracted staff (who all have honorary contracts with the BHSCT) working
within the NI-MPL are supervised by NIB personnel for any work they carry out on
behalf of the NIB.
Job descriptions and contracts
Job descriptions are held within individual training files or available from personnel
departments of the NIB stakeholder organizations.
Staff meetings
Please refer to Section 1: Organisation and Quality Management System for
information on staff meetings
Staff training and education
NIB staff are encouraged to have a training/Continuing Professional Development
folder which includes records of:
-
Personal details, CV, professional memberships
Work based activities
Evidence of attendance at training and development courses
Evidence of mandatory training
Competency document as appropriate
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Section 4: Communications
Internal communication
Internal communication amongst NIB staff is maintained through:
- Regular NIB meetings (Refer to Section 1)
- Dissemination of minutes
- Email
External communication
External communication is maintained through:
-
NIB webpage
NIB annual report
Updates in the CCRCB Bulletin
A number of joint academic and clinical roles are in place within the NIB to help
engage clinical staff and facilitate mutual understanding of biobanking. Promotion of
the NIB and biobanking is also achieved by attendance/presentation of NIB staff at
conferences and events.
Communication with patients and donors
The NIB has established links with the Northern Ireland Cancer Research Consumer
Forum (NICRCF) for lay input into information produced for donors.
This
involvement in future will extend to representation on the NIB Steering Committee
(See Section 1)
Information about accrual numbers and published research studies using NIB
samples is made available to donors via the NIB annual report and the NIB
webpage.
Clinically relevant findings
Prior to consent, potential donors are informed that no attempt will be made by the
NIB to trace research results back to individual patients.
Communication with researchers
The NIB is developing a web-based biosample catalogue to provide information on
the types and numbers of samples held. This will be integrated into the official NIB
webpage.
The NIB is also displayed on the CCB portal, CCRCB webpage and the NI-MPL
webpage.
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Stakeholder feedback
On or shortly after a project end date, researchers will be required to submit a short
end of project report on the progress of their study.
NIB welcomes feedback via the NIB Administrator.
Section 5: Premises and Environment
Premises and environment
The NIB main storage facilities are located within the Northern Ireland Molecular
Pathology Laboratory in the basement of CCRCB, Queen’s University Belfast.
Tissue is collected via the BHSCT Tissue Pathology Laboratories at the Royal
Victoria Hospital and Belfast City Hospital. Blood collected in the Royal Victoria
Hospital site is processed in the basement laboratory of the Centre for Public Health,
Institute of Pathology. Blood collected in the Belfast City Hospital site is processed in
the NICTC laboratory in the Northern Ireland Regional Cancer Centre or in the NIMPL in CCRCB.
Facilities for staff
The NIB has adequate facilities for staff within these buildings.
Facilities for patients
There is no requirement for facilities for patients other than as visitors to the Centre.
Facilities for storage
The NIB’s permanent storage facility is in the basement of CCRCB. Access to this
facility is by electronic pass card / key pad access and is restricted to authorised
individuals only. Visitors are accompanied by authorised personnel at all times.
The NIB has temporary storage facilities in the Institute of Clinical Sciences B
Building, Royal Victoria Hospital, and in the laboratory of the NICTC, Belfast City
Hospital. Access to both facilities is restricted to authorized personnel.
NIB freezers and refrigerators are located in air conditioned rooms. Freezers and
refrigerators are subject to continuous temperature monitoring with remote alarms to
mobile phones and email of designated personnel. Freezer status can also be
monitored online. Back up freezer storage is available on both sites.
Patient consent forms are held in the Northern Ireland Clinical Trials Centre based . .
Access to this facility is by electronic pass card and is restricted to authorised
individuals only. Visitors are accompanied by authorised personnel at all times.
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Health and Safety
The NIB complies with relevant Health and Safety policies and procedures of the
BHSCT and QUB.
Risk Assessments
Risks are assessed for both the tissue sample and the tissue handler and are
reviewed every 2 years. Risk Assessment documents are cross referenced in
appropriate SOPs.
Equipment
All equipment calibration, validation logs and service contracts are maintained by the
different lab managers in different sites (BHSCT Tissue Pathology laboratories,
NICTC laboratory, NI-MPL).
Section 6: Evaluation and quality assurance
Evaluation
Evaluation of the NIB is achieved through:
- Horizontal and vertical, internal and external audits. Please refer to Admin 06
SOP for Audit and Quality Control
- Reports from accreditation bodies
- End of project reports
- Reporting and management of anomalies and non-conformities
- Annual management review
Results or feedback from evaluation activities are discussed at either the Operational
Committee or the Biosampling and Quality Assurance Committee meetings and
reported in the NIB annual report.
Complaints
Please refer to Admin SOP 05 -Complaints
Anomalies and non-conformities
The NIB has procedures in place for the reporting, management and review of
anomalies and non-conformities. Please refer to Admin 02 SOP for Incident
Reporting.
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Section 7: Resources
The NIB storage facility is located within the Northern Ireland Molecular Pathology
Laboratory in a purpose-built area in the basement of the CCRCB, QUB.
Funding for the NIB is a syndicate of three partners. The Health and Social Care
Research and Development Division of the Public Health Agency (HSC R & D
Division) awarded a five year grant to support the day to day running costs and the
majority of the staffing costs (2010-2015)
Cancer Research-UK has provided funds as part of the Belfast CR-UK Centre
initiative to enhance the research infrastructure within the BHSCT Tissue Pathology
departments to facilitate sample accrual and molecular typing.
The Friends of the Cancer Centre has provided funds for the creation of the
Information Management System and for the purchase of a MacroPath Imaging
System.
NIB operates a modest cost recovery model. NIB facilitates BHSCT in the retrieval
of costs from researchers for the acquisition and transfer of samples from the
BHSCT laboratory archives to the NIB storage area. Resources subsequently
created by NIB/NI-MPL staff using samples retrieved from the Tissue Pathology
Archive (eg for the creation of TMAs, extraction of DNA, RNA etc) and distributed by
NIB to researchers are also associated with a modest cost recovery model in order
to subsidize further activities within the NIB.
An environment is being created in Belfast where science is rapidly developing and
where the conventional model for biomarker discovery and validation is changing.
This model provides ‘fit for purpose’ biosamples of high-level quality within a
regulated framework. NIB works closely with the Northern Ireland Molecular
Pathology Laboratory (NI-MPL) to provide an end to end sample collection and
analytical framework for all researchers in Northern Ireland and beyond.
The Scientific Director meets regularly with the chief funder (HSC R & D Division) to
review and amend financial plans, as required and to plan ahead for the continued
financial viability of the Biobank.
The Scientific Director will also explore other sources of funding from charities and
other appropriate sources such as the EU.
In the event that NIB is no longer funded, contingency plans would be drawn up in
consultation with the Confederation of Cancer Biobanks to transfer accrued samples
to an appropriately accredited biobank.
Procurement
NIB operates under the auspices of BHSCT and QUB with regard to the
procurement of items of capital expenditure.
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Subcontracting
Services subcontracted out by the NIB are undertaken by approved subcontractors
in line with QUB or BHSCT policies.
Section 8: Handling of Samples
Consent
Consent for donation to the NIB is undertaken using ethically approved NIB consent
forms and patient information sheets. Please refer to Donor 01 SOP for Informed
Consent for Patients with Solid Tumours and Donor 03 SOP for Informed Consent
for Patients with Haematlogical Malignancies
Patients are given the opportunity to withdraw their consent from the NIB. Please
refer to Donor 02 SOP for Withdrawal of Consent.
Traceability
The NIB has a dedicated Information Management System which conforms to
21CFR11 guidelines for secure access and date/time/user tracking of changes to the
system and meets HTA requirements for traceability of samples. This allows each
sample to have a unique identifier number, to be registered against a collection
protocol, to have a record of significant events and to identify where any sample is at
any time (including release of samples to researchers). Please refer to IT01 SOP for
Data Entry,Sample 07 Transfer and Tracking of Prospectively Collected, PatientConsented samples from NHS to NIB(CCRCB) and Sample 06 Retrieval of samples
from BHSCT Tissue Pathology Archives and Transfer to NIB.
Samples
The NIB has ethical approval to collect surplus tissue for research at the time of
diagnostic sampling, and in addition has approvals in place to retrieve and distribute
anonymised samples from the BHSCT laboratory archives.
The NIB is developing a procedure for the adoption of investigator led tissue
samples from clinical trials including hosting of clinical trials from multiple sites.
Sample collection
For prospective sample collection protocols please refer to disease specific sample
SOPs.
Transport of samples
For the internal transport of prospectively collected samples within the NIB and its
host organisations please refer to NIB Risk AssessmentsRA01 and RA02)
17
For transport of NIB samples outside the NIB and its host organizations, please refer
to Sample 11–SOP for Packaging and Transport of Samples
Selection and release of samples to researchers
See NIB Access Policy
Quality control of samples
Please see Admin 06 SOP for Audit and Quality Control
Proficiency testing
The NIB and/or laboratories used by the NIB participate are subject to relevant
internal and external quality assurance testing.
Disposal of samples
Disposal of samples is undertaken according to the HTA Code of Practice 5:
Disposal of Human Tissue. NIB Samples for disposal follow the procedures within
CCRCB and the NI-MPL – see NI-MPL-SOP-0036-Waste Disposal-E1A (QUB S
drive).
Section 9: Handling Data
Data
Hard copies of the NIB pathologist’s reporting proformas are held by the NIB
Biomedical Scientists based in the Tissue Pathology laboratories. The data is
inputed directly into the NIB IMS by NHS-employed NIB staff for all prospectively
collected tissue samples
For associated clinical data, please refer to SOP on Admin 04 Data Collection,
Storage and Dissemination.
Data protection
The NIB operates within the requirements of law ie Data Protection Act and the
Belfast Health & Social Care Trust (BHSCT) policies for data access. Linkage of
clinico-pathological data to biosamples samples held within the NIB for subsequent
distribution in an anonymised form to researchers has been approved by the Office
of the Data Guardian of the BHSCT. A service level agreement has been formalized
with the Northern Ireland Cancer Registry to facilitate this linkage of relevant clinical
and pathological data.
Data Security
Access to the NIB IMS is by individual logins for authorised personnel only. Levels
of permission are approved by the NIB Senior Management Team and arranged via
18
the NIB Administrator. The IMS incorporates a robust back-up procedure in the
event of a failure which may result in loss of live electronic data. Please refer to IT
SOPs for further information.
Data quality
-
Regular audits of the IMS are undertaken to identify missing data or fields
which are not completed correctly. Please refer to Admin 06 SOP for Audit
and Quality Control
Return of research data
See Access Policy
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