Data Protection and Privacy
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.
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.