Marion Flood NHS GGC. Safe Haven
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- Marilyn Waters
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1 Marion Flood NHS GGC Safe Haven
2 Safe Haven (phase 1) NHS Greater Glasgow and Clyde (NHSGG&C) is developing a Safe Haven to support the secondary research uses of clinical data. This development is supported by the Scottish Government through the Chief Scientist Office It is in partnership with the Robertson Centre for Biostatistics (RCB), University of Glasgow. Governance is via a Local Privacy Advisory Committee (LPAC) whose primary function is to protect the privacy and confidentiality of our patients.
3 Safe Haven Governance NHS datasets GP Data Safe Haven IT Infrastructure SQL cluster Node 1 Node 2 NHS Safe Haven Database Anonymised server RCB Clinical Trials Research Data SMR Core Dataset Db1 Data Requests Linked CHI Seeding SCI Store Db2 Db2 Application server PACS Other Datasets Db3 Db3 LPAC decisions Dumb terminals
4 Local Privacy Advisory Committee Mary Sweetland CHAIR Marian Stewart Judith Godden Isobel Brown Andy Crawford GGC Caldicott Guardian Ethics Scientific Officer Information Governance Manager Head of Clinical Governance Richard Groden Clinical Director, Glasgow City CHP TBC John Ip Duncan Porter Frances Paton Patient Representative LMC Representative Acute Clinician Business Intelligence Manager (Information Services) All unconsented datasets have a finite lifetime determined by the Privacy Advisory Committee and will include statistical disclosure control.
5 Safe Haven Data Request Process Research Audit Service Evaluation FOI Scientific Officer WoS Ethics Refer to NHSGGC FOI Policy Clinical Governance Is dataset already available in Safe Haven? No Complete LPAC application for linkage of new dataset Yes Dataset approved Is data consented? No Complete RAS application for unconsented data (Safe Haven) Safe Haven Committee Yes Complete IRAS application for study (REC approval) Ethics approval required Submit application to LPAC for decision No Is application approved? Apply for R&D Approval Apply to Safe Haven with clinical study name and Ethics approval number Safe Haven Committee Is application approved? Yes Yes No n.b During the start up phase, all applications to Safe Haven will be submitted to LPAC for approval Application declined (appeals process?) Provide access to Safe Haven
6 Going Live Use key projects to: write applications test systems understand quality/ limitations of specific NHS data sets involved understand real time availability of data build a core dataset
7 GP data Core Dataset data items, including lifestyle, diagnosis, co-morbidities, social circumstances, contra-indications, drugs E-prescribing data SMR data GRO data - Encashed prescriptions, BNF categorised - Hospital admission data - Death records for GGC Key Clinical datasets - Clinical datasets from locally held applications
8 Key Exemplar Projects The Safe Haven will provide a service for clinical trials including feasibility, e-recruitment and follow up using healthcare information: SCOT: Standard care versus Celecoxib Outcome Trial in patients with osteo or rheumatoid arthritis. A Large Streamlined Safety Study which can be linked with other clinical data. Stratified Medicine: Genetic cancer research project looking at six cancer types; breast, ovarian, lung, prostrate, melanoma and colorectal.
9 Key Exemplar Projects TRUST: An EU funded, multinational study for elderly patients with subclinical hypothyroidism: a randomised placebo controlled trial of Hormone replacement therapy FAST: A prospective, randomised, open label, blinded endpoint clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with gout EHR4CR: European clinical research project looking at the feasibility of identifying patients electronically
10 Metadata Safe Haven Metadata accessible via website Catalogue of datasets held within safe haven: No of records within each dataset Time period Data quality issues Data dictionary for each dataset: List of available data items Comprehensive definition for each data item held Data type
11 The Future Phase 2 develop system for wider access to datasets Phase 3 extension across NRS -West Any Questions?
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