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Recording Clinical Data

Recording Clinical Data. Robert Pickard Professor of Urology Newcastle University, UK robert.pickard@newcastle.ac.uk. Why, What, Where, How. Things to consider Compliance with data protection act Compliance with NHS ethics Compliance with policies and standards of NHS organisation

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Recording Clinical Data

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  1. Recording Clinical Data Robert Pickard Professor of UrologyNewcastle 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

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