Virtual Research Environment Professor Richard O. Sinnott & Anthony Stell 25 th September 2010

2 Overview Proposal Work Plan Recap VRE –Introduction to and demonstration of ACC registry –Organisation and Support for Clinical Studies PMT-exemplar –Biobanking Support and Data Linkage Next steps

3 VRE::Proposal Description A state-of-the-art Virtual Research Environment (VRE) will provide the foundation for all of research phases and clinical trials associated with The VRE will comprise a clinical registry for patients with ACC/MPH and a collection of tools for security-oriented data access, linkage, analysis, annotation and storage for the associated work packages. It will support training and educational materials, and offer collaborative tools such as wikis and discussion forums. The VRE will allow incorporation of clinical annotation and hosting of secondary data from the human-based research projects in order to create a wider scientific research environment seamlessly and securely providing access to clinical and biomedical data sets. To address the sensitivity of data access and linkage, the VRE will support the secure upload and querying of clinical and other data sets associated with adrenal tumours, and where feasible the federated access to data sets across partner sites. In the realisation of this model in we shall allow for seamless linkage of clinical data sets available through the VRE with biomaterials and associated data sets without direct data linkage and hence risk of further data disclosure or linkage with other data sets. This model is especially suited to biobanking situations where clear separation of clinical information and biomaterials is demanded for confidentiality and data disclosure concerns.

4 VRE::Proposal Description UoM Tasks –#1: Supporting the Requirements of the Partner Sites –#2: Continuous security evaluation, risk assessment and ethical evaluation of the VRE –#3: Design, Development, Testing and Maintenance of the VRE –#4: VRE Clinical Trial Support –#5: VRE Biobanking Support Resourcing –75 man months for VRE development 60 man months (Anthony Stell) 12 man months (Jipu Jiang) 3 man months for WP1 lead

5 Track Record National e-Science Centre (I, II, III) Dynamic Virtual Organisations for e-Science Education Biomedical Research Informatics Delivered by Grid Enabled Services GridNet Grid Enabled Microarray Expression Profile Search Glasgow early adoption of Shibboleth Joint Data Standards Survey ESP-Grid GridNet-2 HPC Compute cluster award Sun industrial sponsorship OGC Collision OMII-Security Portlets OMII-RAVE Integrating VOMS and PERMIS for Superior Grid Authorization NCeSS Technical Management CESSDA PPP Pharming of Therapeutic RNA Grid Enabled Occupational Data Environment Towards an e-Infrastructure for e-Science Digital Repositories Grid enabled Biochemical Pathway Simulator Virtual Organisations for Trials and Epidemiological Studies A European e-Infrastructure for e-Science Repositories Modelling, Inference and Analysis for Biological Systems up to the Cellular Level Drug Discovery Portal Advanced Grid Authorisation through Semantic Technologies ShinTau (Supporting Multiple Shibboleth Attribute Authorities) Grid-enabled Virtual Safe Settings Scottish Bioinformatics Research Network (SBRN) Generation Scotland Scottish Family Health Study Meeting the Design Challenges of nanoCMOS Electronics (nanoCMOS) EU FW7 EuroDSD EU FW7 AvertIT Breast Cancer Tissue Biobank Data Management through e-Social Science (DAMES) NeSC Research Platform (NRP) NeSC Information Network (NIN) ESF Network for Study of Adrenal Tumors Scottish Health Informatics Platform for Research (SHIP) National E-Infrastructure for Social Simulation (NeISS) Enhancing Repositories for Language and Literature Researchers (ENROLLER) Proxy Credential Auditing Infrastructure for the NGS EU FW7 European Network for Study of Adrenal Tumors Cancer Research Platform EU R4SME Diagnosis of Parkinsons Disease (DiPAR) EU European Platform for Study of Wolfram, Alstrom, Bardet Biedl CompletedOn-Going

6 Anthony (and ENSAT work to now)

ENSAT-CANCER Consortium Meeting Anthony Stell, National e-Science Centre, Glasgow 25 th September 2010, Munich, Germany

ENSAT Registry

ACC - Structure Identification Diagnostic Procedures Tumor Staging Biomaterial Surgery Radiotherapy Chemotherapy Mitotane Chemo- embolisation Follow-Up Pathology Treatments

ACC - Functionality [Walkthrough – video…]

Pheo, NAPACA, APA

Clinical Studies – Pheo-PMT [Walkthrough – video…]

Pheo, NAPACA, APA

Clinical Studies - Others FIRSTMAPP ADIUVO Required… –Identifiers –Central information (i.e. “once only information) –Forms –Repeated patterns

Identifiers ENSAT ID –e.g. FRPA1-3 Study ID –e.g. 1VGYDR001 Common codes –Country and centre (enclosed) Ramifications –Foreign keys from study to registry

Security Programmatic security Encryption Audit trails

Biobanking and data linkage Clinicians ENSAT Registry Biomaterial IDs Biomaterial Clinician A Paris, Centre 1 (Patient Mr X) FRPA1-3 Local LIMS (XYZ123) 1VFRP13001=XYZ123 1VFRP13001 Researchers BioCentre Paris 1VFRP13001 Researcher, Birmingham UK ? ? ? Ethics Consent 1VFRP13001

18 Next Steps Hardening ACC and Pheo/PGL –Schema for database(s) –Functionality (data validation/…) –Usability Requirements capture –Functional imaging platform –Adrenal cancer pathology platform –Adrenal cancer genomics platform –Hormone biomarker platform –Translation adrenal cancer models –Clinical trials ADIUVO/FIRSTMAPP –eCRFs for different phases –Data extraction –… Centralised vs Federated Models

19 Next Steps …ctd Security policy –Definition and enforcement Access and authorisation management Collaboration – s –Audio-confs/skype –Pre-2011 meetings $$$ Data quality management?

20 Questions 20