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

2. Plan General points to consider Documentation Storage Sharing
What I will be talking about

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
. Will need R&D approval plus Caldicott guardian.

4. Points to consider: study specific
REC submission and study protocol
Patient information sheets and consent forms
REC asks to set out: what data will be collected, how it will be stored, who can access, how long it will be stored for (need to justify if longer than 12 months)

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
From NHS records – remains their property, cannot share with 3rd party

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 Identifiers Paper, electronic, audio, samples – BACK-UP
Anonymous (no audit trail)
Pseudoanonymous (audit trial) – most usual
Patient-identifiable data (to be avoided if possible)
PID = names, numbers or other details sufficient enough to identify them. Keep in separate location

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
Lockable filing cabinet/drawer; secure room; password protected; if on disk then disk must be kept securely

12. Sharing – You need permission!
The patient (consent)
Research Ethics Committee
Caldicott Guardian
HTA: anything that contains cells
Caldicott – protection of PID in health service. May allow us to access data but agreement generally not to share with any third party!

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:

14. Questions?