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Recording Clinical Data

Recording Clinical Data. Richard Oliver Head of Information Governance Newcastle upon Tyne Hospitals NHS Trust Additional slides: Professor Rob Pickard. Plan. General points to consider Documentation Storage Sharing. General points to consider. Compliance with Data P rotection Act

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Recording Clinical Data

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  1. Recording Clinical Data Richard Oliver Head of Information Governance Newcastle upon Tyne Hospitals NHS Trust Additional slides: Professor Rob Pickard

  2. Plan • General points to consider • Documentation • Storage • Sharing

  3. General points to consider • Compliance with Data Protection Act • General Data Protection Regulations (May 2018) • Necessary approvals (REC, NHS Trusts) • Where NHS patients, data or facilities are involved: • Compliance with policies and standards of NHS organisation (inc.Caldicott) • Status of data collector with NHS organisation

  4. Points to consider: study specific • REC submission and study protocol • Patient information sheets and consent forms

  5. Consent Forms

  6. GDPR & Research • A data controller must have a legal basis for collection and use of data. • Research is not in itself a legal basis. • Consent is key. • Consent must be explicit and affirmative.

  7. Caldicott Principles 1) Justify the purpose for which the information is needed. 2) Only use personally identifiable information when absolutely necessary. 3) Use the minimum personal identifiable information possible – if possible use an identifier number rather than a name. 4) Access to the information should be on a strict need to know basis. 5) Everyone should be aware of his/her responsibilities to respect clients confidentiality. 6) Understand and comply with the law. The most relevant legislation is the GDPR 2018, the Police & Criminal Evidence Act 1984 and the Human Rights Act 1998.

  8. Documentation – What data to record? • Collect enough but no more • From NHS records (can include name, address to contact patient) • Data collected during study

  9. Documentation • Legible • Accurate and complete • Date, time, signature, name and designation • Corrections made with single line strike-through, initialled and dated

  10. Storage • Medium • Paper, electronic, audio, samples – BACK-UP • Identifiers • Anonymous (no audit trail) • Pseudoanonymous (audit trial) – most usual • Patient-identifiable data (to be avoided if possible)

  11. Storage: University Policy • Adequate, relevant and not excessive • Accurate • Not kept for longer than is necessary • Kept safe from unauthorised access, accidental loss or destruction • Secure rooms/lockable cabinets • Password protected

  12. Sharing – You need permission! • The patient (consent) • Research Ethics Committee • Caldicott Guardian

  13. Key Point • Know what you are allowed to do • REC application / protocol • Patient information sheets / consent forms • Agreements with NHS bodies • University Policy and legislation:http://www.ncl.ac.uk/res/research/ethics_governance/ethics/toolkit/data/

  14. Questions?

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