Data Protection and Privacy
Actively involved in UK SDE/TRE space - contributed to DARE UK SATRE, leading UKTRE IG working group, contributing to NHS SDE delivery
Working with a UKCRC-registered CTU to implement risk-proportionate computer system validation
Delivering computer system validation training to UK academia/NHS organisations
Provided strategic guidance to university medical division on research IS/IG good practice, structures and resourcing
Co-chair Trusted Research Environment sub-group for JISC NHS-HE IG Working Group
Lead DSPT delivery for very large university medical department
Lead review and update of ECRINS Data Centre Standards for EU
Supported a university with its developing Secure Data Environment strategy
Regulatory soft-audit of CTU systems/trial documentation; strategic advice on CAPA and implementation
Delivered 'emergency' DSPT for major international research collaboration based at leading UK university
Consultancy to university dental school on systems/governance
Regulatory soft-audit of CTU covering IT systems, CRF development and documentation; recommendations for CAPA
Information systems audit/MHRA prep for large CTU
Provided information system design consultancy to national research programme
Led project to develop an in-house TRE for a Russel Group university including associated IG policy framework.
Supported a UKCRC Registered CTU with validation of REDCap, including validation plan, detailed implementation guidance and regulatory documentation.
Provided EDC validation advice to an NHS research group.
Leading an EDC system validation project for a UKCRC Registered CTU.
Supporting an national research programme with implementation of an EDC system.
Built a REDCap database for an international cardiac trial.
Supported a Scottish university in setting up a TRE delivered through a commercial service provider.
Systems audit of a UKCRC Registered CTU on behalf of an NHS sponsor.
Co-ordinating functional requirements gathering from users of a national hospital-based CTMS.
Contributed to NIHR COVID19 response by leading feasibility assessment of a rapid national EDC solution to support urgent research.
Providing expert input to a cross-agency (NIHR, MHRA, HRA) project to implement data standards.
Provided expert guidance to a national data registry on provision of secure data services.
Strategic review of IT system architecture and infrastructure for a UKCRC Registered CTU.
Providing IG and technical guidance to a university-based national research centre in procuring a secure data storage facility and developing a bespoke online database.
MHRA-style audit of IT infrastructure and databases (focus on system validation) for a UKCRC Registered CTU.
Provided mentoring and guidance to a new CTU IT lead.
Contributed to the
2018 ECRINS Standards
Led a national review of CTU EDC use for the
NIHR Digital Programme
Supported a University research institute through a successful ISO27001 audit.
Providing ongoing strategic IS support to a CTU.
Strategic consultancy to a CTU on EDC systems and UKCRC Registration.
Provided system validation training to a CTU programming team including recommended processes and document templates.
Supported a CTU with the procurement of a new EDC system, including market review, systematic evaluation and recommendation.
Supported development of a new University-based CTU including staffing structures and roles, computer systems and information governance.
Provided strategic advice to a UKCRC Registered CTU on staffing, cost-models and systems.
Provided strategic support to a developing CTU on system choice and integration, roles and organisational structure.
Assisted two CTUs in achieving provisional UKCRC Registration in 2017.
'Soft' regulatory-style audit of a UKCRC Registered CTU.
Supported a CTU with development of job descriptions and provided expert advice on interview panel.
Worked with a CTU to develop database documentation process and templates compliant with regulatory system validation expectations.
Provided advice and guidance to a UKCRC Registered CTU on system validation strategies and practice.
Provided advice on national EDC strategy to a major research charity.