1. Recording Clinical Data Robert Pickard Professor of Urology Newcastle University, UK robert.pickard@newcastle.ac.uk

2. Why, What, Where, How Things to consider Compliance with data protection act Compliance with NHS ethics Compliance with policies and standards of NHS organisation Status of data collector with NHS organisation Common sense

3. Why Map to research question Human disease phenotype – Demographics – Disease characteristics – Patient-driven characteristics such as QoL – Qualitative or ethnographic research – Outcomes

4. What Define your minimum data set Collect enough but no more Abstract from records – Electronic – Paper – Samples (pathology) Qualitative – Tapes, videos, filed notes

5. Where You need permission The patient (consent) Research Ethics Committee (for anything that is additional to standard care) Human tissue act (material transfer agreement) Audit committee Caldicott Guardian Honorary contract (research passport)

6. How Consider Medium – Paper, electronic, audio, samples – BACK-UP Identifiers – Anonymous (no audit trail) – Pseudoanonymous (audit trial) – most usual – Patient – identifiable data – Minefield (don’t go there) Names Numbers Sufficient personal details